nigms -- tips for new nih grant applicants page 1...

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These tips were gathered by NIGMS staff members. Suggestions for additions to the list are welcome, and should be sent to [email protected] . First Steps 1. Find out about the institutional support that is available to you (such as a startup package). 2. Broaden your vision beyond that which you had as a student. 3. Seek mentoring. 4. Instead of feedback, try "feed forward." (This approach, put forth by Dr. Keith Yamamoto of the University of California, San Francisco, involves asking three senior colleagues to act as your "grant committee" and discussing your ideas for the application with them before starting the writing process. Next, write one page of three to five specific aims and discuss these with the committee before beginning to write the body of the application. Thus, by the time you tackle the bulk of the writing, the organization and content of your proposal have received fairly detailed scrutiny and critical consideration.) Start Work 5. Have a good idea! 6. Establish your independence as an investigator. 7. Generate preliminary data. 8. Enlist collaborators and include letters that clearly spell out the collaborations in your proposal. 9. Look at successful proposals of colleagues in your field. 10. Contact NIH by Web and by phone to reach people who want to help you: l NIH -- http://www.nih.gov l Center for Scientific Review-- http://www.csr.nih.gov/ l National Institute of General Medical Sciences -- http://www.nigms.nih.gov/ l Computer Retrieval of Information on Scientific Projects (CRISP, a searchable database of federally funded biomedical research projects)-- http://crisp.cit.nih.gov Start Writing Page 1 of 2 NIGMS -- Tips for New NIH Grant Applicants 3/20/2002 http://www.nigms.nih.gov/funding/tips.html

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Page 1: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

These tips were gathered by NIGMS staff members Suggestions for additions to the list are welcome and should be sent to ruizbrannigmsnihgov

First Steps

1 Find out about the institutional support that is available to you (such as a startup package)

2 Broaden your vision beyond that which you had as a student

3 Seek mentoring

4 Instead of feedback try feed forward (This approach put forth by Dr Keith Yamamoto of the University of California San Francisco involves asking three senior colleagues to act as your grant committee and discussing your ideas for the application with them before starting the writing process Next write one page of three to five specific aims and discuss these with the committee before beginning to write the body of the application Thus by the time you tackle the bulk of the writing the organization and content of your proposal have received fairly detailed scrutiny and critical consideration)

Start Work

5 Have a good idea

6 Establish your independence as an investigator

7 Generate preliminary data

8 Enlist collaborators and include letters that clearly spell out the collaborations in your proposal

9 Look at successful proposals of colleagues in your field

10 Contact NIH by Web and by phone to reach people who want to help you

l NIH--httpwwwnihgov

l Center for Scientific Review--httpwwwcsrnihgov

l National Institute of General Medical Sciences --httpwwwnigmsnihgov

l Computer Retrieval of Information on Scientific Projects (CRISP a searchable database of federally funded biomedical research projects)--httpcrispcitnihgov

Start Writing

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11 Prepare your proposal early--well before the deadline Do not rush

12 Make your first proposal your best proposal Convey your confidence and enthusiasm for the project

13 Do your homework and know the literature and issues questions and controversies in your area

14 Place your work in perspective Cite others If there are two camps make sure you cite both sides

15 Make your priorities clear Provide a timeline

16 Be focused

17 Discuss potential problems and pitfalls Describe alternate strategies

18 Carefully consider your funding needs Start with personnel--you will need to explain fully the role of each person on the grant Review the NIH modular grant rules which specify that you must request funds in $25000 modules and which do not permit increments for inflation in the out -years In order to arrive at an appropriate bottom-line figure you will have to treat the budget as a 4- or 5-year budget you should get expert assistance in this preparation Although you will not have to detail budgetary needs keep in mind that the reviewers will judge your competence in part by how well your funding request matches the scope of the project

19 Use a clear and concise writing style

20 Proofread Have zero tolerance for typographical errors misspellings or sloppy formatting

21 Critique your own proposal

22 Have others read your final draft as well

After Review

23 Remember that reviewers and the NIH program directors who influence funding decisions usually try to give new investigators a break

24 If you are not funded the first time around revise your application carefully Consult your program director for advice

25 If you are funded be sure to talk with your program director at least once a year to discuss your progress

National Institute of General Medical Sciences National Institutes of Health Bethesda Maryland 20892-6200

Last updated November 1 1999 Last reviewed February 13 2001

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A SHORT GUIDE TO THE PREPARATION OF NIH GRANT APPLICATIONS

TABLE OF CONTENTS

INTRODUCTION ABSTRACT RESEARCH PLAN (overview)

A SPECIFIC AIMS B BACKGROUND AND SIGNIFICANCE C PRELIMINARY RESULTSPROGRESS REPORT D RESEARCH DESIGN AND METHODS

BUDGET AND JUSTIFICATION ASSURANCES

iexcl HUMAN iexcl ANIMAL

RESOURCES AND ENVIRONMENT OVERALL CONSIDERATIONS

INTRODUCTION This information is based very closely on NIH Publication No 93-3606 Quick Guide for the Preparation of Grant Applications written and distributed by the Hispanic Cancer Control Research Network (HCCRN) Hispanic Cancer Control Program Special Populations Studies Branch National Cancer Institute NIH The original publication was the result of a grant-writing workshop sponsored by HCCRN in 1991 and a follow-up activity in 1992 It contains information and suggestions especially pertinent to cancer control research along with more generic information This document has been modified to more specifically meet the needs of investigators preparing applications for laboratory-based research projects

The guide is organized according to the major sections of the PHS-398 Grant Application Instructions Each section is described and a checklist is provided detailing what that section should cover In addition suggestions are included to enhance an applications success The checklists are not exhaustive but rather are designed to job ther application writers memory and ensure completeness This document in no way obviates the need for an inexperienced applicant to seek further advice from experienced colleagues or from appropriate program personnel at NIH

PLANNING YOUR APPLICATION Several key issues should be considered before during and after your application is written

1 The usual deadlines for new NIH grant applications are February 1 June 1 and October 1

2 The usual deadlines for amended applications and competing renewal applications are March 1 July 1 and November 1

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3 Please note The deadlines for investigator-initiated applications related to AIDS and in response to RFAs may differ

4 The review and selection process for applications takes 8 to 10 months Submit your very best application because reviewers expect you to have taken the time needed to think it through before submitting

5 Before you begin writing your grant application read the PHS 398 instructions carefully and become familiar with all the requirements and certifications necessary If you are submitting in response to a published initiative such as Program Announcements (PA) or Request for Applications (RFA) read the PA or RFA in detail If at all possible find someone in your institution who can assist you in understanding and completing the application Ask your colleagues for copies of successful NIH grant applications to get a more concrete idea of what each section should include Incomplete applications are returned without review

6 Establish deadlines for the preparation of the grant application particularly when collaborating investigators are involved Be aware of institutional deadlines that could delay your application Allow time for equipment failures personnel shortages etc

7 Reread your application Have someone else read it Proofread it again

8 If several people are contributing to the writing decide who will do the final editing

9 If possible have objective experts (eg successful grantees an institutional panel) review your proposal Friends or close associates are rarely as critical as the reviewers on an NIH study section

10 Do not feel inhibited about requesting technical assistance from the funding agency or your institution Talk to the program representative who will manage the grant for advice on scientific and technical issues and to the grants management specialist for advice on administrative issues Your institutional grants office can also be of assistance Talk to them and find out how they can help you

11 Investigate any special research priorities of funding agencies and ascertain from the program representative whether your project falls within the scope of an existing initiative (RFA or PA) or an area of special emphasis

12 When submitting a revised application answer all reviewer concerns mentioned in the earlier Summary Statement Changes you make in the revised application must be described and illustrated eg bracketing underlining etc Regardless of how you feel dont insult the reviewers If you differ in your opinion try to courteously convince the reviewers of your point -of views In addition to responding to specific reviewer concerns review all other aspects of the application to determine whether updating or improvement is called for or possible Just because it was not criticized before is no guarantee it will not be criticized in the review of the revised application

13 First Award Applicants letters of reference and institutional commitment are very important particularly the wording or phrasing of these letters You should emphasize this to those who will write your letters The institutional commitment letter in particular should clearly state that the applicant has independent lab space and adequate equipment Any other tangible expression of institutional commitment that might exist (start -up funds support for a technician etc) should be mentioned This indicates to Study Section members that you are not merely a pair of hands but have independence and institutional support

ABSTRACT Purpose The purpose of the abstract is to describe succinctly every major aspect of the proposed project except the budget The abstract is an important part of your application It is used in the grant referral process along with a few other parts of the application to detene what study section is appropriate to review the application and to what institute at NHi it is most relevant Members of the Study Section who are not primary reviewers may rely heavily on the abstract to understand your proposal

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Recommended Length The recommended length of the abstract will vary among different funding agencies but the NIH abstract is a half-page and confined to the designated space provided in the application

Content The abstract should include

iexcl a brief background of the project iexcl specific aims or hypotheses iexcl the unique features of the project iexcl the methodology (action steps) to be used iexcl expected results iexcl evaluation methods and iexcl description of how your results will effect other research areas iexcl the significance of the proposed research

Suggestions 1 Be complete but brief 2 Use all the space allotted 3 View the abstract as your one-page advertisement 4 Write the abstract last so that it reflects the entire proposal Spend time reviewing it 5 Remember that the abstract will have a longer shelf life than the rest of the proposal and may be used

for purposes other than the review such as to provide a brief description of the grant in annual reports presentations or in response to requests from top management at NIH

RESEARCH PLAN (Overview) PurposeThe purpose of the research plan is to describe the what why and how of the proposal This is the core of the proposal and will be reviewed with particular care The what will be Part A Specific Aims the why Part B Background and Significance and the how Part C Preliminary Results contributes to both the why and how Part D Research Design and Methods The assessment of this research plan will largely determine whether or not the proposal is favorably recommended for funding

Recommended Length The maximum length of the research plan is 25 pages

Content The research plan should answer the following questions iexcl What do you intend to do iexcl Why is this worth doing How is it innovative iexcl What has already been done in general and what have other researchers done in this field Use

appropriate references What will this new work add to the field of knowledge iexcl What have you (and your collaborators) done to establish the feasibility of what you are proposing to

do iexcl How will the research be accomplished Who What When Where Why

Suggestions 1 Make sure that all sections (A B C and D--the what why and how of the proposal) are intemally

consistent and that they dovetail with each other Use a numbering system and make sections easy to find Lead the reviewers through your research plan One person should revise and edit the final draft

2 Show knowledge of recent literature and explain how the proposed research will further what is already known

3 Emphasize how some combination of a novel hypothesis important preliminary data a new experimental system andor a new experimental approach will enable important progress to be made

4 Establish credibility of the proposed principal investigator and the collaborating researchers

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RESEARCH PLAN PART A

SPECIFIC AIMS

Purpose The purpose of the specific aims is to describe concisely and realistically what the proposed research is intended to accomplish

Recommended Length The recommended length of the specific aims is one page

Content The specific aims should cover n broad long-term goals n the hypothesis or hypotheses to be tested and n specific time-phased research objectives

Suggestions

1 Generally the Specific Aims section should begin with a brief narrative describing the long-term goals of the project and the hypothesis guiding the research This is followed by a numbered list of the Aims

2 State the hypothesis clearly Make sure it is understandable testable and adequately supported by citations in the Background and by data in the Preliminary Results Sections Be sure to explain how the results to be obtained will be used to test the hypothesis

3 Show that the objectives are attainable within the stated time frame

4 Be as brief and specific as possible For clarity each aim should consist of only one sentence Use a brief paracraph under each aim if detail is needed Most successful applications have 2-4 specific aims

5 Dont bite off more than you can chew A small focused project is generally better received than a difftise multifaceted project

6 Be certain that all aims are related Have someone read them for clarity and cohesiveness

7 Focus on aims where you have good supporting preliminary data and scientific expertise

RESEARCH PLAN PART B

BACKGROUND AND SIGNIFICENCE

Purpose The purpose of the background and significance section is to state the problem to be investigated the rationale for the proposed research the current state of knowledge relevant to the proposal and the potential contribution of this research to the problem(s) addressed

Recommended Length Approximately 3 pages

Content The background and significance section should cover n the rationale for the proposed project n the state of existing knowledge including literature citations and highlights of relevant data n gaps that the project is intended to fill

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Suggestions 1 Make a compelling case for your proposed research project Why is the topic important Why

are the specific research questions important How are the researchers qualified to address these

2 Establish familiarity with recent research findings Avoid outdated research Use citations not only as support for specific statements but also to establish familiarity with all of the relevant publications and points of view Your application may well be reviewed by someone worlcing in your field If their contributions and their point of view are not mentioned they are not iikely to review your application sympathetically

3 Make sure the citations are specifically related to the proposed research Cite and paraphrase correctly and constructively

4 Highlight why research findings are important beyond the confines of a specific project ie how can the results be applied to further research in this field or related areas

5 Stress any innovations in-experimental methods (eg new strategies- research methods used interventions proposed)

RESEARCH PLAN PART C

PRELIMINARY RESULTSPROGRESS REPORT

Purpose The purpose of the preliminary results section is to describe prior work by the investigators relevant to the proposed project In a new application the preliminary results are important to establish the experience and capabilities of the applicant investigators in the area of proposed research and to provide experimental support for the hypothesis and the research design This section is not mandatory for new applications but it is virtually impossible to obtain a favorable review without strong preliminary data In a competing renewal application this section becomes a progress report describing studies performed during the last grant period

Recommended Length The recommended length of the preliminary resultsprogress report section is 6-8 pages

Content The preliminary results section should include the following n most importantly a description of recent studies by the applicant investigators that establish the

feasibility and importance of the proposed project n a brief description of older published studies by the applicant that provide important

background information relevant to the proposed project n results of previous studies by the applicant not directly relevant to the proposed project if they

are needed to establish the applicants competence and experience with the experimental techniques to be used in the proposed project

Suggestions 1 All Tables and Figures necessary for the presentation of preliminary results must be included in

this section of the application Full-size glossy photographs of materials such as electron micrographs gels etc may be included in the appendix but only if a photocopy (reduced in size as appropriate) is included in the body of the Research Plan

2 Figures and Figure legends must be legible There are specific limits on type size given in the application instructions but beyond these rules the critical factor is whether the data are legible and convincing to the reviewers

3 Do not dwell on results already published Summarize the critical findings in the text and include

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reprints of the full article in the appendix Up to 10 publications can be included with the appendix material

RESEARCH PLAN PART D

RESEARCH DESIGN AND METHODS

Purpose The purpose of the research design and methods section is to describe how the research will be carried out This section is crucial to how favorably an application is reviewed

Recommended Length The maximum recommended length of the research design and methods section is 20 pages

Content The research design and methods section should include the following n an overview of the experimental design n a detailed description of specific methods to be employed to accomplish the specific aims n a detailed discussion of the way in which the results will be collected analyzed and interpreted n a projected sequence or timetable (work plan) n a description of any new methodology used and why it represents an improvement over the

existing ones n a discussion of potential difficulties and limitations and how these will be overcome or mitigated n expected results and alternative approaches that will be used if unexpected results are found n precautions to be exercised with respect to any procedures situations or materials that may be

hazardous to personnel or human subjects

Suggestions Number the sections in this part of the application to correspond to the numbers of the Specific Aims

1 Give sufficient detail Do not assume that the reviewers will know how you intend to proceed

2 Avoid excessive experimental detail by referring to publications that describe the methods to be employed Publications cited should be by the applicants if at all possible Citing someone elses publication establishes that you know what method to use but citing your own (or that of a collaborator) establishes that the applicant personnel are experienced with the necessary techniques

3 If relevant explain why one approach or method will be used in preference to others This establishes that the alternatives were not simply overlooked Give not only the how but the why

4 If employing a complex technology for the fast time take extra care to demonstrate familiarity with the experimental details and potential pitfalls Add a coinvestigator or consultant experienced with the technology if necessary

5 Document proposed collaborations and offers of materials or reagents of restricted availability with letters from the individuals involved

BUDGET AND JUSTIFICATION Purpose The purpose of the budget and justification is to present and justify all expenses required to achieve project aims and objectives For multi-institutional applications there must be a separate

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budget for each subcontractor or consortium member

Recommended Length Special forms are provided for the budget and justitication Read the instructions carefully If there is a coinvestigator at another institution for whom funds are requested be sure to include their budget

Content The budget and justification should cover the following n personnel n consultants n equipment n supplies n travel and n other expenses eg animal maintenance

Suggestions

1 Be realistic Both padding and deliberately underbudgeting reflect naivete which will be recognized by reviewers

2 Provide brief descriptions of duties for all positions listed in the budget with the percentage of effort requested each year and any anticipated flucations Special skills or accomplishments of a designated person may be included if not discussed elsewhere

3 If possible try to identify specific individuals for each position requested To be named personnel are very often deleted by reviewers

4 Justify all equipment purchases The proposed acquisition of major pieces of equipment is likely to be scrutinized very carefully Details are important especially for non-project specific equipment eg FAX machine and computers

5 Break out supply costs into major categories (reagents disposables etc) Provide special justification for any unusual expenses requested

6 Detail and justify travel costs Make sure they reflect cuffent fares and lodging costs and that proposed travel is project related

7 Explain any year-to-year fluctuations in the budget including the level of effort of personnel especially if they can not be attributed to routine salary increases Changes should parallel the research plan and project aims

8 Check indirect costs Some institutions have on-campus and off -campus rates

9 Be complete but concise There are no page limits in this section

10 Provide adequate justification for the need to use outside consultants if applicable

11 The budget must be approved by the grantee institution business office before they can sign the application

12 If applicable provide documentation of institutional rates for animal maintenance and acquisition Exceptionally large numbers of animals will need detailed justification

13 Prorate service contracts to percentage of time equipment is used for this project

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ASSURANCES Purpose The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines

Recommended Length A special form must be completed for the assurances section See page B of the PHS 398 application

Content The assurances cover n human subjects n vertebrate animals n inventions and patents n debarment and suspension n drug-free workplace n lobbying n delinquent Federal debt n misconduct in science n civil rights n handicapped individuals n sex discrimination and n age discrimination

Suggestions 1 Be familiar with assurances certifications and requirements for complying with these

regulations

2 Begin to obtain assurances early since they tend to require the cooperation of different institutions

3 Check your institutions grants management office for additional requirements Different institutions follow different procedures and timelines

HUMAN SUBJECTS Purpose The purpose of this section describing the involvement of human subjects is to ensure the protection of the rights and welfare of people who participate in research projects

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section If an exemption has been designated in item 4a on the face page enough detail still must be provided to allow the determination of the appropriateness of the exemption If no exemption is claimed there are six points which must be addressed in this section A full description of these points can be found on page 22 of the PHS 398 application package Be thorough in addressing these six areas

All research applications involving human subjects must address the issue of inclusion of women and minorities in the subject population A justification is required if there is limited representation of women and minorities Peer review and NIH program staff will consider this justification in their evaluation of your application Failure to address this issue will impose a bar making any award until all the concems raised by the IRG have been resolved

The assurance of compliance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 4b of the face page as must the IRB approval date

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Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving human subjects requires a current review by your Institutional Review Board (IRB) Be sure to provide the most recent review date for your project

3 You must provide information on the inclusion of women and minorities in the study population

VERTEBRATE ANIMALS Purpose The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section There are five points which must be addressed in this section A full description of these points can be found on page 23 of the PHS 398 application package Be thorough in addressing these five areas Failure to address any of these areas will delay any award until these issues have been resolved

The animal welfare assurance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 5b of the face page as must the IACUC approval date

Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC) Be sure to provide the most recent review date for your project

3 Be sure the number of animals proposed is realistic

4 Justify all animal expenses

RESOURCES AND ENVIRONMENT Purpose The purpose of the resources and environment section is to describe the resources facilities and support available to the researcher

Recommended Length A special form is provided for the resources and environment section

Suggestions 1 Make sure the resources and environment section addresses all requirements of the proposed

research plan

2 Justify any reliance on resources external to the research

3 Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem

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4 Make certain your resources and budget requests are consistent

OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

2 Use basic English and avoid jargon

3 Make sure all acronyms are spelled out when used initially

4 Type single-spaced and stay within the margins

5 Observe the type size and page limitations strictly do not use a small font

6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

9 List all citations (six pages maximum) at the end of the research plan

10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

11 Have an outside reader review the proposal for clarity and consistency

12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

13 Be consistent with terms references and forrn writing style

14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

16 Make sure all the check-box items on page II of the PHS 398 application are completed

17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

DEA Home

created 27sep95 Lorrie Smith revised 02apr98

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Home | Search | Sitemap | Contact

About NICHD | News amp Events | Health Information amp Media | Funding by NICHD | Intramural Research Epidemiology Statistics amp Prevention | Employment amp Fellowships | Research Resources

Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

The following slides were presented at the University of Louisville on September 23 and 24 1999

Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

Slides Table of Contents

l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

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Third Edition amended August 30 2001

The Original How to Write a Research Grant Application

Contents

Strategy for Getting an NIH Grant 2

Writing an Application for a Research Project Grant 3

I Before You Begin 4

II Application Contents 5

III Developing Your Research Plan 6

IV Application Contents Other Than the Research Plan 15

V Writing and Formatting 18

VI Submitting Your Grant Application 20

VII Problems and Concerns Commonly Cited by Reviewers 21

VIII Referral and Assignment of the Application 23

IX Review of Research Project Applications 24

X How Funding Is Decided 27

XI When You Have Not Obtained Funding 29

XII When Your Application Is Approved for Funding 32

Checklists 35

Strategy for Getting an NIH Grant

1 Assess competition in the field

2 Know the level of resources needed to compete

- do an organizational assessment

- look for opportunities to build research with support from various sources

- get a mentor

3 Be willing to change yourself your projects your career

4 Know the opportunities in the field for

- collaboration with a known laboratory or mentor

- carving out a niche

5 Find out which NIH institutes supporting research in your area are seeking applications

- go to our list of program announcements (PA) on the Web and requests for applications (RFA)

- discuss your ideas with Institute program staff See NIAIDs program and staff listing

6 Make sure you and your collaborators are properly trained for the research

7 Closely examine grant applications from successful grantees

8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

9 Have several experienced grantees critique your application

10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

Writing an Application for a Research Project Grant

There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

Eight Basic Questions Reviewers Ask

1 How high are the intellectual quality and merit of the study

2 What is its potential impact

3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

4 Is the hypothesis valid and have you presented evidence supporting it

5 Are the aims logical

6 Are the procedures appropriate adequate and feasible for the research

7 Are the investigators qualified Have they shown competence credentials and experience

8 Are the facilities adequate and the environment conducive to the research

Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

I Before You Begin

Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

Developing the Hypothesis

Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

State your hypothesis in both the specific aims section of the research plan and the abstract

II Application Contents

Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

III Developing Your Research Plan

A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

- Your application should be based on a strong hypothesis

- Be sure your project has a coherent direction

- Keep the sections of the plan well coordinated and clearly related to the central focus

- Emphasize mechanism A good grant application asks questions about biological mechanisms

- Dont be overly ambitious your plan should be based on a feasible timetable

- Specific aims and experiments should relate directly to the hypothesis to be tested

A Specific Aims

Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

B Background and Significance

Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

Identify the next logical stage of research beyond your current application

C Preliminary StudiesProgress Report

By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

D Research Design and Methods

Describe the experimental design and procedures in detail and give a rationale for their use

Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

advantageous to the research you propose to do

More and more applicants are including colored charts graphs and photographs in their applications

Approach

State why you chose your approach or approaches as opposed to others

If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

Consider the limitations of each approach and how it may affect your results and the data generated

Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

Results

Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

Describe your proposed statistical methods for analyzing the data you plan to collect

Define the criteria for evaluating the success or failure of a specific test

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 2: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

11 Prepare your proposal early--well before the deadline Do not rush

12 Make your first proposal your best proposal Convey your confidence and enthusiasm for the project

13 Do your homework and know the literature and issues questions and controversies in your area

14 Place your work in perspective Cite others If there are two camps make sure you cite both sides

15 Make your priorities clear Provide a timeline

16 Be focused

17 Discuss potential problems and pitfalls Describe alternate strategies

18 Carefully consider your funding needs Start with personnel--you will need to explain fully the role of each person on the grant Review the NIH modular grant rules which specify that you must request funds in $25000 modules and which do not permit increments for inflation in the out -years In order to arrive at an appropriate bottom-line figure you will have to treat the budget as a 4- or 5-year budget you should get expert assistance in this preparation Although you will not have to detail budgetary needs keep in mind that the reviewers will judge your competence in part by how well your funding request matches the scope of the project

19 Use a clear and concise writing style

20 Proofread Have zero tolerance for typographical errors misspellings or sloppy formatting

21 Critique your own proposal

22 Have others read your final draft as well

After Review

23 Remember that reviewers and the NIH program directors who influence funding decisions usually try to give new investigators a break

24 If you are not funded the first time around revise your application carefully Consult your program director for advice

25 If you are funded be sure to talk with your program director at least once a year to discuss your progress

National Institute of General Medical Sciences National Institutes of Health Bethesda Maryland 20892-6200

Last updated November 1 1999 Last reviewed February 13 2001

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A SHORT GUIDE TO THE PREPARATION OF NIH GRANT APPLICATIONS

TABLE OF CONTENTS

INTRODUCTION ABSTRACT RESEARCH PLAN (overview)

A SPECIFIC AIMS B BACKGROUND AND SIGNIFICANCE C PRELIMINARY RESULTSPROGRESS REPORT D RESEARCH DESIGN AND METHODS

BUDGET AND JUSTIFICATION ASSURANCES

iexcl HUMAN iexcl ANIMAL

RESOURCES AND ENVIRONMENT OVERALL CONSIDERATIONS

INTRODUCTION This information is based very closely on NIH Publication No 93-3606 Quick Guide for the Preparation of Grant Applications written and distributed by the Hispanic Cancer Control Research Network (HCCRN) Hispanic Cancer Control Program Special Populations Studies Branch National Cancer Institute NIH The original publication was the result of a grant-writing workshop sponsored by HCCRN in 1991 and a follow-up activity in 1992 It contains information and suggestions especially pertinent to cancer control research along with more generic information This document has been modified to more specifically meet the needs of investigators preparing applications for laboratory-based research projects

The guide is organized according to the major sections of the PHS-398 Grant Application Instructions Each section is described and a checklist is provided detailing what that section should cover In addition suggestions are included to enhance an applications success The checklists are not exhaustive but rather are designed to job ther application writers memory and ensure completeness This document in no way obviates the need for an inexperienced applicant to seek further advice from experienced colleagues or from appropriate program personnel at NIH

PLANNING YOUR APPLICATION Several key issues should be considered before during and after your application is written

1 The usual deadlines for new NIH grant applications are February 1 June 1 and October 1

2 The usual deadlines for amended applications and competing renewal applications are March 1 July 1 and November 1

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3 Please note The deadlines for investigator-initiated applications related to AIDS and in response to RFAs may differ

4 The review and selection process for applications takes 8 to 10 months Submit your very best application because reviewers expect you to have taken the time needed to think it through before submitting

5 Before you begin writing your grant application read the PHS 398 instructions carefully and become familiar with all the requirements and certifications necessary If you are submitting in response to a published initiative such as Program Announcements (PA) or Request for Applications (RFA) read the PA or RFA in detail If at all possible find someone in your institution who can assist you in understanding and completing the application Ask your colleagues for copies of successful NIH grant applications to get a more concrete idea of what each section should include Incomplete applications are returned without review

6 Establish deadlines for the preparation of the grant application particularly when collaborating investigators are involved Be aware of institutional deadlines that could delay your application Allow time for equipment failures personnel shortages etc

7 Reread your application Have someone else read it Proofread it again

8 If several people are contributing to the writing decide who will do the final editing

9 If possible have objective experts (eg successful grantees an institutional panel) review your proposal Friends or close associates are rarely as critical as the reviewers on an NIH study section

10 Do not feel inhibited about requesting technical assistance from the funding agency or your institution Talk to the program representative who will manage the grant for advice on scientific and technical issues and to the grants management specialist for advice on administrative issues Your institutional grants office can also be of assistance Talk to them and find out how they can help you

11 Investigate any special research priorities of funding agencies and ascertain from the program representative whether your project falls within the scope of an existing initiative (RFA or PA) or an area of special emphasis

12 When submitting a revised application answer all reviewer concerns mentioned in the earlier Summary Statement Changes you make in the revised application must be described and illustrated eg bracketing underlining etc Regardless of how you feel dont insult the reviewers If you differ in your opinion try to courteously convince the reviewers of your point -of views In addition to responding to specific reviewer concerns review all other aspects of the application to determine whether updating or improvement is called for or possible Just because it was not criticized before is no guarantee it will not be criticized in the review of the revised application

13 First Award Applicants letters of reference and institutional commitment are very important particularly the wording or phrasing of these letters You should emphasize this to those who will write your letters The institutional commitment letter in particular should clearly state that the applicant has independent lab space and adequate equipment Any other tangible expression of institutional commitment that might exist (start -up funds support for a technician etc) should be mentioned This indicates to Study Section members that you are not merely a pair of hands but have independence and institutional support

ABSTRACT Purpose The purpose of the abstract is to describe succinctly every major aspect of the proposed project except the budget The abstract is an important part of your application It is used in the grant referral process along with a few other parts of the application to detene what study section is appropriate to review the application and to what institute at NHi it is most relevant Members of the Study Section who are not primary reviewers may rely heavily on the abstract to understand your proposal

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Recommended Length The recommended length of the abstract will vary among different funding agencies but the NIH abstract is a half-page and confined to the designated space provided in the application

Content The abstract should include

iexcl a brief background of the project iexcl specific aims or hypotheses iexcl the unique features of the project iexcl the methodology (action steps) to be used iexcl expected results iexcl evaluation methods and iexcl description of how your results will effect other research areas iexcl the significance of the proposed research

Suggestions 1 Be complete but brief 2 Use all the space allotted 3 View the abstract as your one-page advertisement 4 Write the abstract last so that it reflects the entire proposal Spend time reviewing it 5 Remember that the abstract will have a longer shelf life than the rest of the proposal and may be used

for purposes other than the review such as to provide a brief description of the grant in annual reports presentations or in response to requests from top management at NIH

RESEARCH PLAN (Overview) PurposeThe purpose of the research plan is to describe the what why and how of the proposal This is the core of the proposal and will be reviewed with particular care The what will be Part A Specific Aims the why Part B Background and Significance and the how Part C Preliminary Results contributes to both the why and how Part D Research Design and Methods The assessment of this research plan will largely determine whether or not the proposal is favorably recommended for funding

Recommended Length The maximum length of the research plan is 25 pages

Content The research plan should answer the following questions iexcl What do you intend to do iexcl Why is this worth doing How is it innovative iexcl What has already been done in general and what have other researchers done in this field Use

appropriate references What will this new work add to the field of knowledge iexcl What have you (and your collaborators) done to establish the feasibility of what you are proposing to

do iexcl How will the research be accomplished Who What When Where Why

Suggestions 1 Make sure that all sections (A B C and D--the what why and how of the proposal) are intemally

consistent and that they dovetail with each other Use a numbering system and make sections easy to find Lead the reviewers through your research plan One person should revise and edit the final draft

2 Show knowledge of recent literature and explain how the proposed research will further what is already known

3 Emphasize how some combination of a novel hypothesis important preliminary data a new experimental system andor a new experimental approach will enable important progress to be made

4 Establish credibility of the proposed principal investigator and the collaborating researchers

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RESEARCH PLAN PART A

SPECIFIC AIMS

Purpose The purpose of the specific aims is to describe concisely and realistically what the proposed research is intended to accomplish

Recommended Length The recommended length of the specific aims is one page

Content The specific aims should cover n broad long-term goals n the hypothesis or hypotheses to be tested and n specific time-phased research objectives

Suggestions

1 Generally the Specific Aims section should begin with a brief narrative describing the long-term goals of the project and the hypothesis guiding the research This is followed by a numbered list of the Aims

2 State the hypothesis clearly Make sure it is understandable testable and adequately supported by citations in the Background and by data in the Preliminary Results Sections Be sure to explain how the results to be obtained will be used to test the hypothesis

3 Show that the objectives are attainable within the stated time frame

4 Be as brief and specific as possible For clarity each aim should consist of only one sentence Use a brief paracraph under each aim if detail is needed Most successful applications have 2-4 specific aims

5 Dont bite off more than you can chew A small focused project is generally better received than a difftise multifaceted project

6 Be certain that all aims are related Have someone read them for clarity and cohesiveness

7 Focus on aims where you have good supporting preliminary data and scientific expertise

RESEARCH PLAN PART B

BACKGROUND AND SIGNIFICENCE

Purpose The purpose of the background and significance section is to state the problem to be investigated the rationale for the proposed research the current state of knowledge relevant to the proposal and the potential contribution of this research to the problem(s) addressed

Recommended Length Approximately 3 pages

Content The background and significance section should cover n the rationale for the proposed project n the state of existing knowledge including literature citations and highlights of relevant data n gaps that the project is intended to fill

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Suggestions 1 Make a compelling case for your proposed research project Why is the topic important Why

are the specific research questions important How are the researchers qualified to address these

2 Establish familiarity with recent research findings Avoid outdated research Use citations not only as support for specific statements but also to establish familiarity with all of the relevant publications and points of view Your application may well be reviewed by someone worlcing in your field If their contributions and their point of view are not mentioned they are not iikely to review your application sympathetically

3 Make sure the citations are specifically related to the proposed research Cite and paraphrase correctly and constructively

4 Highlight why research findings are important beyond the confines of a specific project ie how can the results be applied to further research in this field or related areas

5 Stress any innovations in-experimental methods (eg new strategies- research methods used interventions proposed)

RESEARCH PLAN PART C

PRELIMINARY RESULTSPROGRESS REPORT

Purpose The purpose of the preliminary results section is to describe prior work by the investigators relevant to the proposed project In a new application the preliminary results are important to establish the experience and capabilities of the applicant investigators in the area of proposed research and to provide experimental support for the hypothesis and the research design This section is not mandatory for new applications but it is virtually impossible to obtain a favorable review without strong preliminary data In a competing renewal application this section becomes a progress report describing studies performed during the last grant period

Recommended Length The recommended length of the preliminary resultsprogress report section is 6-8 pages

Content The preliminary results section should include the following n most importantly a description of recent studies by the applicant investigators that establish the

feasibility and importance of the proposed project n a brief description of older published studies by the applicant that provide important

background information relevant to the proposed project n results of previous studies by the applicant not directly relevant to the proposed project if they

are needed to establish the applicants competence and experience with the experimental techniques to be used in the proposed project

Suggestions 1 All Tables and Figures necessary for the presentation of preliminary results must be included in

this section of the application Full-size glossy photographs of materials such as electron micrographs gels etc may be included in the appendix but only if a photocopy (reduced in size as appropriate) is included in the body of the Research Plan

2 Figures and Figure legends must be legible There are specific limits on type size given in the application instructions but beyond these rules the critical factor is whether the data are legible and convincing to the reviewers

3 Do not dwell on results already published Summarize the critical findings in the text and include

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reprints of the full article in the appendix Up to 10 publications can be included with the appendix material

RESEARCH PLAN PART D

RESEARCH DESIGN AND METHODS

Purpose The purpose of the research design and methods section is to describe how the research will be carried out This section is crucial to how favorably an application is reviewed

Recommended Length The maximum recommended length of the research design and methods section is 20 pages

Content The research design and methods section should include the following n an overview of the experimental design n a detailed description of specific methods to be employed to accomplish the specific aims n a detailed discussion of the way in which the results will be collected analyzed and interpreted n a projected sequence or timetable (work plan) n a description of any new methodology used and why it represents an improvement over the

existing ones n a discussion of potential difficulties and limitations and how these will be overcome or mitigated n expected results and alternative approaches that will be used if unexpected results are found n precautions to be exercised with respect to any procedures situations or materials that may be

hazardous to personnel or human subjects

Suggestions Number the sections in this part of the application to correspond to the numbers of the Specific Aims

1 Give sufficient detail Do not assume that the reviewers will know how you intend to proceed

2 Avoid excessive experimental detail by referring to publications that describe the methods to be employed Publications cited should be by the applicants if at all possible Citing someone elses publication establishes that you know what method to use but citing your own (or that of a collaborator) establishes that the applicant personnel are experienced with the necessary techniques

3 If relevant explain why one approach or method will be used in preference to others This establishes that the alternatives were not simply overlooked Give not only the how but the why

4 If employing a complex technology for the fast time take extra care to demonstrate familiarity with the experimental details and potential pitfalls Add a coinvestigator or consultant experienced with the technology if necessary

5 Document proposed collaborations and offers of materials or reagents of restricted availability with letters from the individuals involved

BUDGET AND JUSTIFICATION Purpose The purpose of the budget and justification is to present and justify all expenses required to achieve project aims and objectives For multi-institutional applications there must be a separate

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budget for each subcontractor or consortium member

Recommended Length Special forms are provided for the budget and justitication Read the instructions carefully If there is a coinvestigator at another institution for whom funds are requested be sure to include their budget

Content The budget and justification should cover the following n personnel n consultants n equipment n supplies n travel and n other expenses eg animal maintenance

Suggestions

1 Be realistic Both padding and deliberately underbudgeting reflect naivete which will be recognized by reviewers

2 Provide brief descriptions of duties for all positions listed in the budget with the percentage of effort requested each year and any anticipated flucations Special skills or accomplishments of a designated person may be included if not discussed elsewhere

3 If possible try to identify specific individuals for each position requested To be named personnel are very often deleted by reviewers

4 Justify all equipment purchases The proposed acquisition of major pieces of equipment is likely to be scrutinized very carefully Details are important especially for non-project specific equipment eg FAX machine and computers

5 Break out supply costs into major categories (reagents disposables etc) Provide special justification for any unusual expenses requested

6 Detail and justify travel costs Make sure they reflect cuffent fares and lodging costs and that proposed travel is project related

7 Explain any year-to-year fluctuations in the budget including the level of effort of personnel especially if they can not be attributed to routine salary increases Changes should parallel the research plan and project aims

8 Check indirect costs Some institutions have on-campus and off -campus rates

9 Be complete but concise There are no page limits in this section

10 Provide adequate justification for the need to use outside consultants if applicable

11 The budget must be approved by the grantee institution business office before they can sign the application

12 If applicable provide documentation of institutional rates for animal maintenance and acquisition Exceptionally large numbers of animals will need detailed justification

13 Prorate service contracts to percentage of time equipment is used for this project

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ASSURANCES Purpose The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines

Recommended Length A special form must be completed for the assurances section See page B of the PHS 398 application

Content The assurances cover n human subjects n vertebrate animals n inventions and patents n debarment and suspension n drug-free workplace n lobbying n delinquent Federal debt n misconduct in science n civil rights n handicapped individuals n sex discrimination and n age discrimination

Suggestions 1 Be familiar with assurances certifications and requirements for complying with these

regulations

2 Begin to obtain assurances early since they tend to require the cooperation of different institutions

3 Check your institutions grants management office for additional requirements Different institutions follow different procedures and timelines

HUMAN SUBJECTS Purpose The purpose of this section describing the involvement of human subjects is to ensure the protection of the rights and welfare of people who participate in research projects

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section If an exemption has been designated in item 4a on the face page enough detail still must be provided to allow the determination of the appropriateness of the exemption If no exemption is claimed there are six points which must be addressed in this section A full description of these points can be found on page 22 of the PHS 398 application package Be thorough in addressing these six areas

All research applications involving human subjects must address the issue of inclusion of women and minorities in the subject population A justification is required if there is limited representation of women and minorities Peer review and NIH program staff will consider this justification in their evaluation of your application Failure to address this issue will impose a bar making any award until all the concems raised by the IRG have been resolved

The assurance of compliance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 4b of the face page as must the IRB approval date

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Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving human subjects requires a current review by your Institutional Review Board (IRB) Be sure to provide the most recent review date for your project

3 You must provide information on the inclusion of women and minorities in the study population

VERTEBRATE ANIMALS Purpose The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section There are five points which must be addressed in this section A full description of these points can be found on page 23 of the PHS 398 application package Be thorough in addressing these five areas Failure to address any of these areas will delay any award until these issues have been resolved

The animal welfare assurance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 5b of the face page as must the IACUC approval date

Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC) Be sure to provide the most recent review date for your project

3 Be sure the number of animals proposed is realistic

4 Justify all animal expenses

RESOURCES AND ENVIRONMENT Purpose The purpose of the resources and environment section is to describe the resources facilities and support available to the researcher

Recommended Length A special form is provided for the resources and environment section

Suggestions 1 Make sure the resources and environment section addresses all requirements of the proposed

research plan

2 Justify any reliance on resources external to the research

3 Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem

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4 Make certain your resources and budget requests are consistent

OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

2 Use basic English and avoid jargon

3 Make sure all acronyms are spelled out when used initially

4 Type single-spaced and stay within the margins

5 Observe the type size and page limitations strictly do not use a small font

6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

9 List all citations (six pages maximum) at the end of the research plan

10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

11 Have an outside reader review the proposal for clarity and consistency

12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

13 Be consistent with terms references and forrn writing style

14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

16 Make sure all the check-box items on page II of the PHS 398 application are completed

17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

DEA Home

created 27sep95 Lorrie Smith revised 02apr98

Page 10 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

3202002httpdeainfoncinihgovextraextdocsgntapphtm

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Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

The following slides were presented at the University of Louisville on September 23 and 24 1999

Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

Slides Table of Contents

l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

Page 1 of 1How to Apply for NIH Funding (slides)

3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

Third Edition amended August 30 2001

The Original How to Write a Research Grant Application

Contents

Strategy for Getting an NIH Grant 2

Writing an Application for a Research Project Grant 3

I Before You Begin 4

II Application Contents 5

III Developing Your Research Plan 6

IV Application Contents Other Than the Research Plan 15

V Writing and Formatting 18

VI Submitting Your Grant Application 20

VII Problems and Concerns Commonly Cited by Reviewers 21

VIII Referral and Assignment of the Application 23

IX Review of Research Project Applications 24

X How Funding Is Decided 27

XI When You Have Not Obtained Funding 29

XII When Your Application Is Approved for Funding 32

Checklists 35

Strategy for Getting an NIH Grant

1 Assess competition in the field

2 Know the level of resources needed to compete

- do an organizational assessment

- look for opportunities to build research with support from various sources

- get a mentor

3 Be willing to change yourself your projects your career

4 Know the opportunities in the field for

- collaboration with a known laboratory or mentor

- carving out a niche

5 Find out which NIH institutes supporting research in your area are seeking applications

- go to our list of program announcements (PA) on the Web and requests for applications (RFA)

- discuss your ideas with Institute program staff See NIAIDs program and staff listing

6 Make sure you and your collaborators are properly trained for the research

7 Closely examine grant applications from successful grantees

8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

9 Have several experienced grantees critique your application

10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

Writing an Application for a Research Project Grant

There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

Eight Basic Questions Reviewers Ask

1 How high are the intellectual quality and merit of the study

2 What is its potential impact

3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

4 Is the hypothesis valid and have you presented evidence supporting it

5 Are the aims logical

6 Are the procedures appropriate adequate and feasible for the research

7 Are the investigators qualified Have they shown competence credentials and experience

8 Are the facilities adequate and the environment conducive to the research

Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

I Before You Begin

Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

Developing the Hypothesis

Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

State your hypothesis in both the specific aims section of the research plan and the abstract

II Application Contents

Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

III Developing Your Research Plan

A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

- Your application should be based on a strong hypothesis

- Be sure your project has a coherent direction

- Keep the sections of the plan well coordinated and clearly related to the central focus

- Emphasize mechanism A good grant application asks questions about biological mechanisms

- Dont be overly ambitious your plan should be based on a feasible timetable

- Specific aims and experiments should relate directly to the hypothesis to be tested

A Specific Aims

Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

B Background and Significance

Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

Identify the next logical stage of research beyond your current application

C Preliminary StudiesProgress Report

By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

D Research Design and Methods

Describe the experimental design and procedures in detail and give a rationale for their use

Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

advantageous to the research you propose to do

More and more applicants are including colored charts graphs and photographs in their applications

Approach

State why you chose your approach or approaches as opposed to others

If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

Consider the limitations of each approach and how it may affect your results and the data generated

Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

Results

Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

Describe your proposed statistical methods for analyzing the data you plan to collect

Define the criteria for evaluating the success or failure of a specific test

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 3: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

A SHORT GUIDE TO THE PREPARATION OF NIH GRANT APPLICATIONS

TABLE OF CONTENTS

INTRODUCTION ABSTRACT RESEARCH PLAN (overview)

A SPECIFIC AIMS B BACKGROUND AND SIGNIFICANCE C PRELIMINARY RESULTSPROGRESS REPORT D RESEARCH DESIGN AND METHODS

BUDGET AND JUSTIFICATION ASSURANCES

iexcl HUMAN iexcl ANIMAL

RESOURCES AND ENVIRONMENT OVERALL CONSIDERATIONS

INTRODUCTION This information is based very closely on NIH Publication No 93-3606 Quick Guide for the Preparation of Grant Applications written and distributed by the Hispanic Cancer Control Research Network (HCCRN) Hispanic Cancer Control Program Special Populations Studies Branch National Cancer Institute NIH The original publication was the result of a grant-writing workshop sponsored by HCCRN in 1991 and a follow-up activity in 1992 It contains information and suggestions especially pertinent to cancer control research along with more generic information This document has been modified to more specifically meet the needs of investigators preparing applications for laboratory-based research projects

The guide is organized according to the major sections of the PHS-398 Grant Application Instructions Each section is described and a checklist is provided detailing what that section should cover In addition suggestions are included to enhance an applications success The checklists are not exhaustive but rather are designed to job ther application writers memory and ensure completeness This document in no way obviates the need for an inexperienced applicant to seek further advice from experienced colleagues or from appropriate program personnel at NIH

PLANNING YOUR APPLICATION Several key issues should be considered before during and after your application is written

1 The usual deadlines for new NIH grant applications are February 1 June 1 and October 1

2 The usual deadlines for amended applications and competing renewal applications are March 1 July 1 and November 1

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3 Please note The deadlines for investigator-initiated applications related to AIDS and in response to RFAs may differ

4 The review and selection process for applications takes 8 to 10 months Submit your very best application because reviewers expect you to have taken the time needed to think it through before submitting

5 Before you begin writing your grant application read the PHS 398 instructions carefully and become familiar with all the requirements and certifications necessary If you are submitting in response to a published initiative such as Program Announcements (PA) or Request for Applications (RFA) read the PA or RFA in detail If at all possible find someone in your institution who can assist you in understanding and completing the application Ask your colleagues for copies of successful NIH grant applications to get a more concrete idea of what each section should include Incomplete applications are returned without review

6 Establish deadlines for the preparation of the grant application particularly when collaborating investigators are involved Be aware of institutional deadlines that could delay your application Allow time for equipment failures personnel shortages etc

7 Reread your application Have someone else read it Proofread it again

8 If several people are contributing to the writing decide who will do the final editing

9 If possible have objective experts (eg successful grantees an institutional panel) review your proposal Friends or close associates are rarely as critical as the reviewers on an NIH study section

10 Do not feel inhibited about requesting technical assistance from the funding agency or your institution Talk to the program representative who will manage the grant for advice on scientific and technical issues and to the grants management specialist for advice on administrative issues Your institutional grants office can also be of assistance Talk to them and find out how they can help you

11 Investigate any special research priorities of funding agencies and ascertain from the program representative whether your project falls within the scope of an existing initiative (RFA or PA) or an area of special emphasis

12 When submitting a revised application answer all reviewer concerns mentioned in the earlier Summary Statement Changes you make in the revised application must be described and illustrated eg bracketing underlining etc Regardless of how you feel dont insult the reviewers If you differ in your opinion try to courteously convince the reviewers of your point -of views In addition to responding to specific reviewer concerns review all other aspects of the application to determine whether updating or improvement is called for or possible Just because it was not criticized before is no guarantee it will not be criticized in the review of the revised application

13 First Award Applicants letters of reference and institutional commitment are very important particularly the wording or phrasing of these letters You should emphasize this to those who will write your letters The institutional commitment letter in particular should clearly state that the applicant has independent lab space and adequate equipment Any other tangible expression of institutional commitment that might exist (start -up funds support for a technician etc) should be mentioned This indicates to Study Section members that you are not merely a pair of hands but have independence and institutional support

ABSTRACT Purpose The purpose of the abstract is to describe succinctly every major aspect of the proposed project except the budget The abstract is an important part of your application It is used in the grant referral process along with a few other parts of the application to detene what study section is appropriate to review the application and to what institute at NHi it is most relevant Members of the Study Section who are not primary reviewers may rely heavily on the abstract to understand your proposal

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Recommended Length The recommended length of the abstract will vary among different funding agencies but the NIH abstract is a half-page and confined to the designated space provided in the application

Content The abstract should include

iexcl a brief background of the project iexcl specific aims or hypotheses iexcl the unique features of the project iexcl the methodology (action steps) to be used iexcl expected results iexcl evaluation methods and iexcl description of how your results will effect other research areas iexcl the significance of the proposed research

Suggestions 1 Be complete but brief 2 Use all the space allotted 3 View the abstract as your one-page advertisement 4 Write the abstract last so that it reflects the entire proposal Spend time reviewing it 5 Remember that the abstract will have a longer shelf life than the rest of the proposal and may be used

for purposes other than the review such as to provide a brief description of the grant in annual reports presentations or in response to requests from top management at NIH

RESEARCH PLAN (Overview) PurposeThe purpose of the research plan is to describe the what why and how of the proposal This is the core of the proposal and will be reviewed with particular care The what will be Part A Specific Aims the why Part B Background and Significance and the how Part C Preliminary Results contributes to both the why and how Part D Research Design and Methods The assessment of this research plan will largely determine whether or not the proposal is favorably recommended for funding

Recommended Length The maximum length of the research plan is 25 pages

Content The research plan should answer the following questions iexcl What do you intend to do iexcl Why is this worth doing How is it innovative iexcl What has already been done in general and what have other researchers done in this field Use

appropriate references What will this new work add to the field of knowledge iexcl What have you (and your collaborators) done to establish the feasibility of what you are proposing to

do iexcl How will the research be accomplished Who What When Where Why

Suggestions 1 Make sure that all sections (A B C and D--the what why and how of the proposal) are intemally

consistent and that they dovetail with each other Use a numbering system and make sections easy to find Lead the reviewers through your research plan One person should revise and edit the final draft

2 Show knowledge of recent literature and explain how the proposed research will further what is already known

3 Emphasize how some combination of a novel hypothesis important preliminary data a new experimental system andor a new experimental approach will enable important progress to be made

4 Establish credibility of the proposed principal investigator and the collaborating researchers

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RESEARCH PLAN PART A

SPECIFIC AIMS

Purpose The purpose of the specific aims is to describe concisely and realistically what the proposed research is intended to accomplish

Recommended Length The recommended length of the specific aims is one page

Content The specific aims should cover n broad long-term goals n the hypothesis or hypotheses to be tested and n specific time-phased research objectives

Suggestions

1 Generally the Specific Aims section should begin with a brief narrative describing the long-term goals of the project and the hypothesis guiding the research This is followed by a numbered list of the Aims

2 State the hypothesis clearly Make sure it is understandable testable and adequately supported by citations in the Background and by data in the Preliminary Results Sections Be sure to explain how the results to be obtained will be used to test the hypothesis

3 Show that the objectives are attainable within the stated time frame

4 Be as brief and specific as possible For clarity each aim should consist of only one sentence Use a brief paracraph under each aim if detail is needed Most successful applications have 2-4 specific aims

5 Dont bite off more than you can chew A small focused project is generally better received than a difftise multifaceted project

6 Be certain that all aims are related Have someone read them for clarity and cohesiveness

7 Focus on aims where you have good supporting preliminary data and scientific expertise

RESEARCH PLAN PART B

BACKGROUND AND SIGNIFICENCE

Purpose The purpose of the background and significance section is to state the problem to be investigated the rationale for the proposed research the current state of knowledge relevant to the proposal and the potential contribution of this research to the problem(s) addressed

Recommended Length Approximately 3 pages

Content The background and significance section should cover n the rationale for the proposed project n the state of existing knowledge including literature citations and highlights of relevant data n gaps that the project is intended to fill

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Suggestions 1 Make a compelling case for your proposed research project Why is the topic important Why

are the specific research questions important How are the researchers qualified to address these

2 Establish familiarity with recent research findings Avoid outdated research Use citations not only as support for specific statements but also to establish familiarity with all of the relevant publications and points of view Your application may well be reviewed by someone worlcing in your field If their contributions and their point of view are not mentioned they are not iikely to review your application sympathetically

3 Make sure the citations are specifically related to the proposed research Cite and paraphrase correctly and constructively

4 Highlight why research findings are important beyond the confines of a specific project ie how can the results be applied to further research in this field or related areas

5 Stress any innovations in-experimental methods (eg new strategies- research methods used interventions proposed)

RESEARCH PLAN PART C

PRELIMINARY RESULTSPROGRESS REPORT

Purpose The purpose of the preliminary results section is to describe prior work by the investigators relevant to the proposed project In a new application the preliminary results are important to establish the experience and capabilities of the applicant investigators in the area of proposed research and to provide experimental support for the hypothesis and the research design This section is not mandatory for new applications but it is virtually impossible to obtain a favorable review without strong preliminary data In a competing renewal application this section becomes a progress report describing studies performed during the last grant period

Recommended Length The recommended length of the preliminary resultsprogress report section is 6-8 pages

Content The preliminary results section should include the following n most importantly a description of recent studies by the applicant investigators that establish the

feasibility and importance of the proposed project n a brief description of older published studies by the applicant that provide important

background information relevant to the proposed project n results of previous studies by the applicant not directly relevant to the proposed project if they

are needed to establish the applicants competence and experience with the experimental techniques to be used in the proposed project

Suggestions 1 All Tables and Figures necessary for the presentation of preliminary results must be included in

this section of the application Full-size glossy photographs of materials such as electron micrographs gels etc may be included in the appendix but only if a photocopy (reduced in size as appropriate) is included in the body of the Research Plan

2 Figures and Figure legends must be legible There are specific limits on type size given in the application instructions but beyond these rules the critical factor is whether the data are legible and convincing to the reviewers

3 Do not dwell on results already published Summarize the critical findings in the text and include

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reprints of the full article in the appendix Up to 10 publications can be included with the appendix material

RESEARCH PLAN PART D

RESEARCH DESIGN AND METHODS

Purpose The purpose of the research design and methods section is to describe how the research will be carried out This section is crucial to how favorably an application is reviewed

Recommended Length The maximum recommended length of the research design and methods section is 20 pages

Content The research design and methods section should include the following n an overview of the experimental design n a detailed description of specific methods to be employed to accomplish the specific aims n a detailed discussion of the way in which the results will be collected analyzed and interpreted n a projected sequence or timetable (work plan) n a description of any new methodology used and why it represents an improvement over the

existing ones n a discussion of potential difficulties and limitations and how these will be overcome or mitigated n expected results and alternative approaches that will be used if unexpected results are found n precautions to be exercised with respect to any procedures situations or materials that may be

hazardous to personnel or human subjects

Suggestions Number the sections in this part of the application to correspond to the numbers of the Specific Aims

1 Give sufficient detail Do not assume that the reviewers will know how you intend to proceed

2 Avoid excessive experimental detail by referring to publications that describe the methods to be employed Publications cited should be by the applicants if at all possible Citing someone elses publication establishes that you know what method to use but citing your own (or that of a collaborator) establishes that the applicant personnel are experienced with the necessary techniques

3 If relevant explain why one approach or method will be used in preference to others This establishes that the alternatives were not simply overlooked Give not only the how but the why

4 If employing a complex technology for the fast time take extra care to demonstrate familiarity with the experimental details and potential pitfalls Add a coinvestigator or consultant experienced with the technology if necessary

5 Document proposed collaborations and offers of materials or reagents of restricted availability with letters from the individuals involved

BUDGET AND JUSTIFICATION Purpose The purpose of the budget and justification is to present and justify all expenses required to achieve project aims and objectives For multi-institutional applications there must be a separate

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budget for each subcontractor or consortium member

Recommended Length Special forms are provided for the budget and justitication Read the instructions carefully If there is a coinvestigator at another institution for whom funds are requested be sure to include their budget

Content The budget and justification should cover the following n personnel n consultants n equipment n supplies n travel and n other expenses eg animal maintenance

Suggestions

1 Be realistic Both padding and deliberately underbudgeting reflect naivete which will be recognized by reviewers

2 Provide brief descriptions of duties for all positions listed in the budget with the percentage of effort requested each year and any anticipated flucations Special skills or accomplishments of a designated person may be included if not discussed elsewhere

3 If possible try to identify specific individuals for each position requested To be named personnel are very often deleted by reviewers

4 Justify all equipment purchases The proposed acquisition of major pieces of equipment is likely to be scrutinized very carefully Details are important especially for non-project specific equipment eg FAX machine and computers

5 Break out supply costs into major categories (reagents disposables etc) Provide special justification for any unusual expenses requested

6 Detail and justify travel costs Make sure they reflect cuffent fares and lodging costs and that proposed travel is project related

7 Explain any year-to-year fluctuations in the budget including the level of effort of personnel especially if they can not be attributed to routine salary increases Changes should parallel the research plan and project aims

8 Check indirect costs Some institutions have on-campus and off -campus rates

9 Be complete but concise There are no page limits in this section

10 Provide adequate justification for the need to use outside consultants if applicable

11 The budget must be approved by the grantee institution business office before they can sign the application

12 If applicable provide documentation of institutional rates for animal maintenance and acquisition Exceptionally large numbers of animals will need detailed justification

13 Prorate service contracts to percentage of time equipment is used for this project

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ASSURANCES Purpose The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines

Recommended Length A special form must be completed for the assurances section See page B of the PHS 398 application

Content The assurances cover n human subjects n vertebrate animals n inventions and patents n debarment and suspension n drug-free workplace n lobbying n delinquent Federal debt n misconduct in science n civil rights n handicapped individuals n sex discrimination and n age discrimination

Suggestions 1 Be familiar with assurances certifications and requirements for complying with these

regulations

2 Begin to obtain assurances early since they tend to require the cooperation of different institutions

3 Check your institutions grants management office for additional requirements Different institutions follow different procedures and timelines

HUMAN SUBJECTS Purpose The purpose of this section describing the involvement of human subjects is to ensure the protection of the rights and welfare of people who participate in research projects

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section If an exemption has been designated in item 4a on the face page enough detail still must be provided to allow the determination of the appropriateness of the exemption If no exemption is claimed there are six points which must be addressed in this section A full description of these points can be found on page 22 of the PHS 398 application package Be thorough in addressing these six areas

All research applications involving human subjects must address the issue of inclusion of women and minorities in the subject population A justification is required if there is limited representation of women and minorities Peer review and NIH program staff will consider this justification in their evaluation of your application Failure to address this issue will impose a bar making any award until all the concems raised by the IRG have been resolved

The assurance of compliance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 4b of the face page as must the IRB approval date

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Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving human subjects requires a current review by your Institutional Review Board (IRB) Be sure to provide the most recent review date for your project

3 You must provide information on the inclusion of women and minorities in the study population

VERTEBRATE ANIMALS Purpose The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section There are five points which must be addressed in this section A full description of these points can be found on page 23 of the PHS 398 application package Be thorough in addressing these five areas Failure to address any of these areas will delay any award until these issues have been resolved

The animal welfare assurance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 5b of the face page as must the IACUC approval date

Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC) Be sure to provide the most recent review date for your project

3 Be sure the number of animals proposed is realistic

4 Justify all animal expenses

RESOURCES AND ENVIRONMENT Purpose The purpose of the resources and environment section is to describe the resources facilities and support available to the researcher

Recommended Length A special form is provided for the resources and environment section

Suggestions 1 Make sure the resources and environment section addresses all requirements of the proposed

research plan

2 Justify any reliance on resources external to the research

3 Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem

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4 Make certain your resources and budget requests are consistent

OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

2 Use basic English and avoid jargon

3 Make sure all acronyms are spelled out when used initially

4 Type single-spaced and stay within the margins

5 Observe the type size and page limitations strictly do not use a small font

6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

9 List all citations (six pages maximum) at the end of the research plan

10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

11 Have an outside reader review the proposal for clarity and consistency

12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

13 Be consistent with terms references and forrn writing style

14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

16 Make sure all the check-box items on page II of the PHS 398 application are completed

17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

DEA Home

created 27sep95 Lorrie Smith revised 02apr98

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Home | Search | Sitemap | Contact

About NICHD | News amp Events | Health Information amp Media | Funding by NICHD | Intramural Research Epidemiology Statistics amp Prevention | Employment amp Fellowships | Research Resources

Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

The following slides were presented at the University of Louisville on September 23 and 24 1999

Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

Slides Table of Contents

l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

Page 1 of 1How to Apply for NIH Funding (slides)

3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

Third Edition amended August 30 2001

The Original How to Write a Research Grant Application

Contents

Strategy for Getting an NIH Grant 2

Writing an Application for a Research Project Grant 3

I Before You Begin 4

II Application Contents 5

III Developing Your Research Plan 6

IV Application Contents Other Than the Research Plan 15

V Writing and Formatting 18

VI Submitting Your Grant Application 20

VII Problems and Concerns Commonly Cited by Reviewers 21

VIII Referral and Assignment of the Application 23

IX Review of Research Project Applications 24

X How Funding Is Decided 27

XI When You Have Not Obtained Funding 29

XII When Your Application Is Approved for Funding 32

Checklists 35

Strategy for Getting an NIH Grant

1 Assess competition in the field

2 Know the level of resources needed to compete

- do an organizational assessment

- look for opportunities to build research with support from various sources

- get a mentor

3 Be willing to change yourself your projects your career

4 Know the opportunities in the field for

- collaboration with a known laboratory or mentor

- carving out a niche

5 Find out which NIH institutes supporting research in your area are seeking applications

- go to our list of program announcements (PA) on the Web and requests for applications (RFA)

- discuss your ideas with Institute program staff See NIAIDs program and staff listing

6 Make sure you and your collaborators are properly trained for the research

7 Closely examine grant applications from successful grantees

8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

9 Have several experienced grantees critique your application

10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

Writing an Application for a Research Project Grant

There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

Eight Basic Questions Reviewers Ask

1 How high are the intellectual quality and merit of the study

2 What is its potential impact

3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

4 Is the hypothesis valid and have you presented evidence supporting it

5 Are the aims logical

6 Are the procedures appropriate adequate and feasible for the research

7 Are the investigators qualified Have they shown competence credentials and experience

8 Are the facilities adequate and the environment conducive to the research

Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

I Before You Begin

Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

Developing the Hypothesis

Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

State your hypothesis in both the specific aims section of the research plan and the abstract

II Application Contents

Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

III Developing Your Research Plan

A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

- Your application should be based on a strong hypothesis

- Be sure your project has a coherent direction

- Keep the sections of the plan well coordinated and clearly related to the central focus

- Emphasize mechanism A good grant application asks questions about biological mechanisms

- Dont be overly ambitious your plan should be based on a feasible timetable

- Specific aims and experiments should relate directly to the hypothesis to be tested

A Specific Aims

Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

B Background and Significance

Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

Identify the next logical stage of research beyond your current application

C Preliminary StudiesProgress Report

By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

D Research Design and Methods

Describe the experimental design and procedures in detail and give a rationale for their use

Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

advantageous to the research you propose to do

More and more applicants are including colored charts graphs and photographs in their applications

Approach

State why you chose your approach or approaches as opposed to others

If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

Consider the limitations of each approach and how it may affect your results and the data generated

Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

Results

Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

Describe your proposed statistical methods for analyzing the data you plan to collect

Define the criteria for evaluating the success or failure of a specific test

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 4: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

3 Please note The deadlines for investigator-initiated applications related to AIDS and in response to RFAs may differ

4 The review and selection process for applications takes 8 to 10 months Submit your very best application because reviewers expect you to have taken the time needed to think it through before submitting

5 Before you begin writing your grant application read the PHS 398 instructions carefully and become familiar with all the requirements and certifications necessary If you are submitting in response to a published initiative such as Program Announcements (PA) or Request for Applications (RFA) read the PA or RFA in detail If at all possible find someone in your institution who can assist you in understanding and completing the application Ask your colleagues for copies of successful NIH grant applications to get a more concrete idea of what each section should include Incomplete applications are returned without review

6 Establish deadlines for the preparation of the grant application particularly when collaborating investigators are involved Be aware of institutional deadlines that could delay your application Allow time for equipment failures personnel shortages etc

7 Reread your application Have someone else read it Proofread it again

8 If several people are contributing to the writing decide who will do the final editing

9 If possible have objective experts (eg successful grantees an institutional panel) review your proposal Friends or close associates are rarely as critical as the reviewers on an NIH study section

10 Do not feel inhibited about requesting technical assistance from the funding agency or your institution Talk to the program representative who will manage the grant for advice on scientific and technical issues and to the grants management specialist for advice on administrative issues Your institutional grants office can also be of assistance Talk to them and find out how they can help you

11 Investigate any special research priorities of funding agencies and ascertain from the program representative whether your project falls within the scope of an existing initiative (RFA or PA) or an area of special emphasis

12 When submitting a revised application answer all reviewer concerns mentioned in the earlier Summary Statement Changes you make in the revised application must be described and illustrated eg bracketing underlining etc Regardless of how you feel dont insult the reviewers If you differ in your opinion try to courteously convince the reviewers of your point -of views In addition to responding to specific reviewer concerns review all other aspects of the application to determine whether updating or improvement is called for or possible Just because it was not criticized before is no guarantee it will not be criticized in the review of the revised application

13 First Award Applicants letters of reference and institutional commitment are very important particularly the wording or phrasing of these letters You should emphasize this to those who will write your letters The institutional commitment letter in particular should clearly state that the applicant has independent lab space and adequate equipment Any other tangible expression of institutional commitment that might exist (start -up funds support for a technician etc) should be mentioned This indicates to Study Section members that you are not merely a pair of hands but have independence and institutional support

ABSTRACT Purpose The purpose of the abstract is to describe succinctly every major aspect of the proposed project except the budget The abstract is an important part of your application It is used in the grant referral process along with a few other parts of the application to detene what study section is appropriate to review the application and to what institute at NHi it is most relevant Members of the Study Section who are not primary reviewers may rely heavily on the abstract to understand your proposal

Page 2 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

3202002httpdeainfoncinihgovextraextdocsgntapphtm

Recommended Length The recommended length of the abstract will vary among different funding agencies but the NIH abstract is a half-page and confined to the designated space provided in the application

Content The abstract should include

iexcl a brief background of the project iexcl specific aims or hypotheses iexcl the unique features of the project iexcl the methodology (action steps) to be used iexcl expected results iexcl evaluation methods and iexcl description of how your results will effect other research areas iexcl the significance of the proposed research

Suggestions 1 Be complete but brief 2 Use all the space allotted 3 View the abstract as your one-page advertisement 4 Write the abstract last so that it reflects the entire proposal Spend time reviewing it 5 Remember that the abstract will have a longer shelf life than the rest of the proposal and may be used

for purposes other than the review such as to provide a brief description of the grant in annual reports presentations or in response to requests from top management at NIH

RESEARCH PLAN (Overview) PurposeThe purpose of the research plan is to describe the what why and how of the proposal This is the core of the proposal and will be reviewed with particular care The what will be Part A Specific Aims the why Part B Background and Significance and the how Part C Preliminary Results contributes to both the why and how Part D Research Design and Methods The assessment of this research plan will largely determine whether or not the proposal is favorably recommended for funding

Recommended Length The maximum length of the research plan is 25 pages

Content The research plan should answer the following questions iexcl What do you intend to do iexcl Why is this worth doing How is it innovative iexcl What has already been done in general and what have other researchers done in this field Use

appropriate references What will this new work add to the field of knowledge iexcl What have you (and your collaborators) done to establish the feasibility of what you are proposing to

do iexcl How will the research be accomplished Who What When Where Why

Suggestions 1 Make sure that all sections (A B C and D--the what why and how of the proposal) are intemally

consistent and that they dovetail with each other Use a numbering system and make sections easy to find Lead the reviewers through your research plan One person should revise and edit the final draft

2 Show knowledge of recent literature and explain how the proposed research will further what is already known

3 Emphasize how some combination of a novel hypothesis important preliminary data a new experimental system andor a new experimental approach will enable important progress to be made

4 Establish credibility of the proposed principal investigator and the collaborating researchers

Page 3 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

3202002httpdeainfoncinihgovextraextdocsgntapphtm

RESEARCH PLAN PART A

SPECIFIC AIMS

Purpose The purpose of the specific aims is to describe concisely and realistically what the proposed research is intended to accomplish

Recommended Length The recommended length of the specific aims is one page

Content The specific aims should cover n broad long-term goals n the hypothesis or hypotheses to be tested and n specific time-phased research objectives

Suggestions

1 Generally the Specific Aims section should begin with a brief narrative describing the long-term goals of the project and the hypothesis guiding the research This is followed by a numbered list of the Aims

2 State the hypothesis clearly Make sure it is understandable testable and adequately supported by citations in the Background and by data in the Preliminary Results Sections Be sure to explain how the results to be obtained will be used to test the hypothesis

3 Show that the objectives are attainable within the stated time frame

4 Be as brief and specific as possible For clarity each aim should consist of only one sentence Use a brief paracraph under each aim if detail is needed Most successful applications have 2-4 specific aims

5 Dont bite off more than you can chew A small focused project is generally better received than a difftise multifaceted project

6 Be certain that all aims are related Have someone read them for clarity and cohesiveness

7 Focus on aims where you have good supporting preliminary data and scientific expertise

RESEARCH PLAN PART B

BACKGROUND AND SIGNIFICENCE

Purpose The purpose of the background and significance section is to state the problem to be investigated the rationale for the proposed research the current state of knowledge relevant to the proposal and the potential contribution of this research to the problem(s) addressed

Recommended Length Approximately 3 pages

Content The background and significance section should cover n the rationale for the proposed project n the state of existing knowledge including literature citations and highlights of relevant data n gaps that the project is intended to fill

Page 4 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

3202002httpdeainfoncinihgovextraextdocsgntapphtm

Suggestions 1 Make a compelling case for your proposed research project Why is the topic important Why

are the specific research questions important How are the researchers qualified to address these

2 Establish familiarity with recent research findings Avoid outdated research Use citations not only as support for specific statements but also to establish familiarity with all of the relevant publications and points of view Your application may well be reviewed by someone worlcing in your field If their contributions and their point of view are not mentioned they are not iikely to review your application sympathetically

3 Make sure the citations are specifically related to the proposed research Cite and paraphrase correctly and constructively

4 Highlight why research findings are important beyond the confines of a specific project ie how can the results be applied to further research in this field or related areas

5 Stress any innovations in-experimental methods (eg new strategies- research methods used interventions proposed)

RESEARCH PLAN PART C

PRELIMINARY RESULTSPROGRESS REPORT

Purpose The purpose of the preliminary results section is to describe prior work by the investigators relevant to the proposed project In a new application the preliminary results are important to establish the experience and capabilities of the applicant investigators in the area of proposed research and to provide experimental support for the hypothesis and the research design This section is not mandatory for new applications but it is virtually impossible to obtain a favorable review without strong preliminary data In a competing renewal application this section becomes a progress report describing studies performed during the last grant period

Recommended Length The recommended length of the preliminary resultsprogress report section is 6-8 pages

Content The preliminary results section should include the following n most importantly a description of recent studies by the applicant investigators that establish the

feasibility and importance of the proposed project n a brief description of older published studies by the applicant that provide important

background information relevant to the proposed project n results of previous studies by the applicant not directly relevant to the proposed project if they

are needed to establish the applicants competence and experience with the experimental techniques to be used in the proposed project

Suggestions 1 All Tables and Figures necessary for the presentation of preliminary results must be included in

this section of the application Full-size glossy photographs of materials such as electron micrographs gels etc may be included in the appendix but only if a photocopy (reduced in size as appropriate) is included in the body of the Research Plan

2 Figures and Figure legends must be legible There are specific limits on type size given in the application instructions but beyond these rules the critical factor is whether the data are legible and convincing to the reviewers

3 Do not dwell on results already published Summarize the critical findings in the text and include

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reprints of the full article in the appendix Up to 10 publications can be included with the appendix material

RESEARCH PLAN PART D

RESEARCH DESIGN AND METHODS

Purpose The purpose of the research design and methods section is to describe how the research will be carried out This section is crucial to how favorably an application is reviewed

Recommended Length The maximum recommended length of the research design and methods section is 20 pages

Content The research design and methods section should include the following n an overview of the experimental design n a detailed description of specific methods to be employed to accomplish the specific aims n a detailed discussion of the way in which the results will be collected analyzed and interpreted n a projected sequence or timetable (work plan) n a description of any new methodology used and why it represents an improvement over the

existing ones n a discussion of potential difficulties and limitations and how these will be overcome or mitigated n expected results and alternative approaches that will be used if unexpected results are found n precautions to be exercised with respect to any procedures situations or materials that may be

hazardous to personnel or human subjects

Suggestions Number the sections in this part of the application to correspond to the numbers of the Specific Aims

1 Give sufficient detail Do not assume that the reviewers will know how you intend to proceed

2 Avoid excessive experimental detail by referring to publications that describe the methods to be employed Publications cited should be by the applicants if at all possible Citing someone elses publication establishes that you know what method to use but citing your own (or that of a collaborator) establishes that the applicant personnel are experienced with the necessary techniques

3 If relevant explain why one approach or method will be used in preference to others This establishes that the alternatives were not simply overlooked Give not only the how but the why

4 If employing a complex technology for the fast time take extra care to demonstrate familiarity with the experimental details and potential pitfalls Add a coinvestigator or consultant experienced with the technology if necessary

5 Document proposed collaborations and offers of materials or reagents of restricted availability with letters from the individuals involved

BUDGET AND JUSTIFICATION Purpose The purpose of the budget and justification is to present and justify all expenses required to achieve project aims and objectives For multi-institutional applications there must be a separate

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budget for each subcontractor or consortium member

Recommended Length Special forms are provided for the budget and justitication Read the instructions carefully If there is a coinvestigator at another institution for whom funds are requested be sure to include their budget

Content The budget and justification should cover the following n personnel n consultants n equipment n supplies n travel and n other expenses eg animal maintenance

Suggestions

1 Be realistic Both padding and deliberately underbudgeting reflect naivete which will be recognized by reviewers

2 Provide brief descriptions of duties for all positions listed in the budget with the percentage of effort requested each year and any anticipated flucations Special skills or accomplishments of a designated person may be included if not discussed elsewhere

3 If possible try to identify specific individuals for each position requested To be named personnel are very often deleted by reviewers

4 Justify all equipment purchases The proposed acquisition of major pieces of equipment is likely to be scrutinized very carefully Details are important especially for non-project specific equipment eg FAX machine and computers

5 Break out supply costs into major categories (reagents disposables etc) Provide special justification for any unusual expenses requested

6 Detail and justify travel costs Make sure they reflect cuffent fares and lodging costs and that proposed travel is project related

7 Explain any year-to-year fluctuations in the budget including the level of effort of personnel especially if they can not be attributed to routine salary increases Changes should parallel the research plan and project aims

8 Check indirect costs Some institutions have on-campus and off -campus rates

9 Be complete but concise There are no page limits in this section

10 Provide adequate justification for the need to use outside consultants if applicable

11 The budget must be approved by the grantee institution business office before they can sign the application

12 If applicable provide documentation of institutional rates for animal maintenance and acquisition Exceptionally large numbers of animals will need detailed justification

13 Prorate service contracts to percentage of time equipment is used for this project

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ASSURANCES Purpose The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines

Recommended Length A special form must be completed for the assurances section See page B of the PHS 398 application

Content The assurances cover n human subjects n vertebrate animals n inventions and patents n debarment and suspension n drug-free workplace n lobbying n delinquent Federal debt n misconduct in science n civil rights n handicapped individuals n sex discrimination and n age discrimination

Suggestions 1 Be familiar with assurances certifications and requirements for complying with these

regulations

2 Begin to obtain assurances early since they tend to require the cooperation of different institutions

3 Check your institutions grants management office for additional requirements Different institutions follow different procedures and timelines

HUMAN SUBJECTS Purpose The purpose of this section describing the involvement of human subjects is to ensure the protection of the rights and welfare of people who participate in research projects

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section If an exemption has been designated in item 4a on the face page enough detail still must be provided to allow the determination of the appropriateness of the exemption If no exemption is claimed there are six points which must be addressed in this section A full description of these points can be found on page 22 of the PHS 398 application package Be thorough in addressing these six areas

All research applications involving human subjects must address the issue of inclusion of women and minorities in the subject population A justification is required if there is limited representation of women and minorities Peer review and NIH program staff will consider this justification in their evaluation of your application Failure to address this issue will impose a bar making any award until all the concems raised by the IRG have been resolved

The assurance of compliance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 4b of the face page as must the IRB approval date

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Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving human subjects requires a current review by your Institutional Review Board (IRB) Be sure to provide the most recent review date for your project

3 You must provide information on the inclusion of women and minorities in the study population

VERTEBRATE ANIMALS Purpose The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section There are five points which must be addressed in this section A full description of these points can be found on page 23 of the PHS 398 application package Be thorough in addressing these five areas Failure to address any of these areas will delay any award until these issues have been resolved

The animal welfare assurance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 5b of the face page as must the IACUC approval date

Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC) Be sure to provide the most recent review date for your project

3 Be sure the number of animals proposed is realistic

4 Justify all animal expenses

RESOURCES AND ENVIRONMENT Purpose The purpose of the resources and environment section is to describe the resources facilities and support available to the researcher

Recommended Length A special form is provided for the resources and environment section

Suggestions 1 Make sure the resources and environment section addresses all requirements of the proposed

research plan

2 Justify any reliance on resources external to the research

3 Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem

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4 Make certain your resources and budget requests are consistent

OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

2 Use basic English and avoid jargon

3 Make sure all acronyms are spelled out when used initially

4 Type single-spaced and stay within the margins

5 Observe the type size and page limitations strictly do not use a small font

6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

9 List all citations (six pages maximum) at the end of the research plan

10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

11 Have an outside reader review the proposal for clarity and consistency

12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

13 Be consistent with terms references and forrn writing style

14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

16 Make sure all the check-box items on page II of the PHS 398 application are completed

17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

DEA Home

created 27sep95 Lorrie Smith revised 02apr98

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Home | Search | Sitemap | Contact

About NICHD | News amp Events | Health Information amp Media | Funding by NICHD | Intramural Research Epidemiology Statistics amp Prevention | Employment amp Fellowships | Research Resources

Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

The following slides were presented at the University of Louisville on September 23 and 24 1999

Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

Slides Table of Contents

l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

Page 1 of 1How to Apply for NIH Funding (slides)

3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

Third Edition amended August 30 2001

The Original How to Write a Research Grant Application

Contents

Strategy for Getting an NIH Grant 2

Writing an Application for a Research Project Grant 3

I Before You Begin 4

II Application Contents 5

III Developing Your Research Plan 6

IV Application Contents Other Than the Research Plan 15

V Writing and Formatting 18

VI Submitting Your Grant Application 20

VII Problems and Concerns Commonly Cited by Reviewers 21

VIII Referral and Assignment of the Application 23

IX Review of Research Project Applications 24

X How Funding Is Decided 27

XI When You Have Not Obtained Funding 29

XII When Your Application Is Approved for Funding 32

Checklists 35

Strategy for Getting an NIH Grant

1 Assess competition in the field

2 Know the level of resources needed to compete

- do an organizational assessment

- look for opportunities to build research with support from various sources

- get a mentor

3 Be willing to change yourself your projects your career

4 Know the opportunities in the field for

- collaboration with a known laboratory or mentor

- carving out a niche

5 Find out which NIH institutes supporting research in your area are seeking applications

- go to our list of program announcements (PA) on the Web and requests for applications (RFA)

- discuss your ideas with Institute program staff See NIAIDs program and staff listing

6 Make sure you and your collaborators are properly trained for the research

7 Closely examine grant applications from successful grantees

8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

9 Have several experienced grantees critique your application

10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

Writing an Application for a Research Project Grant

There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

Eight Basic Questions Reviewers Ask

1 How high are the intellectual quality and merit of the study

2 What is its potential impact

3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

4 Is the hypothesis valid and have you presented evidence supporting it

5 Are the aims logical

6 Are the procedures appropriate adequate and feasible for the research

7 Are the investigators qualified Have they shown competence credentials and experience

8 Are the facilities adequate and the environment conducive to the research

Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

I Before You Begin

Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

Developing the Hypothesis

Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

State your hypothesis in both the specific aims section of the research plan and the abstract

II Application Contents

Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

III Developing Your Research Plan

A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

- Your application should be based on a strong hypothesis

- Be sure your project has a coherent direction

- Keep the sections of the plan well coordinated and clearly related to the central focus

- Emphasize mechanism A good grant application asks questions about biological mechanisms

- Dont be overly ambitious your plan should be based on a feasible timetable

- Specific aims and experiments should relate directly to the hypothesis to be tested

A Specific Aims

Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

B Background and Significance

Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

Identify the next logical stage of research beyond your current application

C Preliminary StudiesProgress Report

By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

D Research Design and Methods

Describe the experimental design and procedures in detail and give a rationale for their use

Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

advantageous to the research you propose to do

More and more applicants are including colored charts graphs and photographs in their applications

Approach

State why you chose your approach or approaches as opposed to others

If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

Consider the limitations of each approach and how it may affect your results and the data generated

Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

Results

Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

Describe your proposed statistical methods for analyzing the data you plan to collect

Define the criteria for evaluating the success or failure of a specific test

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 5: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

Recommended Length The recommended length of the abstract will vary among different funding agencies but the NIH abstract is a half-page and confined to the designated space provided in the application

Content The abstract should include

iexcl a brief background of the project iexcl specific aims or hypotheses iexcl the unique features of the project iexcl the methodology (action steps) to be used iexcl expected results iexcl evaluation methods and iexcl description of how your results will effect other research areas iexcl the significance of the proposed research

Suggestions 1 Be complete but brief 2 Use all the space allotted 3 View the abstract as your one-page advertisement 4 Write the abstract last so that it reflects the entire proposal Spend time reviewing it 5 Remember that the abstract will have a longer shelf life than the rest of the proposal and may be used

for purposes other than the review such as to provide a brief description of the grant in annual reports presentations or in response to requests from top management at NIH

RESEARCH PLAN (Overview) PurposeThe purpose of the research plan is to describe the what why and how of the proposal This is the core of the proposal and will be reviewed with particular care The what will be Part A Specific Aims the why Part B Background and Significance and the how Part C Preliminary Results contributes to both the why and how Part D Research Design and Methods The assessment of this research plan will largely determine whether or not the proposal is favorably recommended for funding

Recommended Length The maximum length of the research plan is 25 pages

Content The research plan should answer the following questions iexcl What do you intend to do iexcl Why is this worth doing How is it innovative iexcl What has already been done in general and what have other researchers done in this field Use

appropriate references What will this new work add to the field of knowledge iexcl What have you (and your collaborators) done to establish the feasibility of what you are proposing to

do iexcl How will the research be accomplished Who What When Where Why

Suggestions 1 Make sure that all sections (A B C and D--the what why and how of the proposal) are intemally

consistent and that they dovetail with each other Use a numbering system and make sections easy to find Lead the reviewers through your research plan One person should revise and edit the final draft

2 Show knowledge of recent literature and explain how the proposed research will further what is already known

3 Emphasize how some combination of a novel hypothesis important preliminary data a new experimental system andor a new experimental approach will enable important progress to be made

4 Establish credibility of the proposed principal investigator and the collaborating researchers

Page 3 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

3202002httpdeainfoncinihgovextraextdocsgntapphtm

RESEARCH PLAN PART A

SPECIFIC AIMS

Purpose The purpose of the specific aims is to describe concisely and realistically what the proposed research is intended to accomplish

Recommended Length The recommended length of the specific aims is one page

Content The specific aims should cover n broad long-term goals n the hypothesis or hypotheses to be tested and n specific time-phased research objectives

Suggestions

1 Generally the Specific Aims section should begin with a brief narrative describing the long-term goals of the project and the hypothesis guiding the research This is followed by a numbered list of the Aims

2 State the hypothesis clearly Make sure it is understandable testable and adequately supported by citations in the Background and by data in the Preliminary Results Sections Be sure to explain how the results to be obtained will be used to test the hypothesis

3 Show that the objectives are attainable within the stated time frame

4 Be as brief and specific as possible For clarity each aim should consist of only one sentence Use a brief paracraph under each aim if detail is needed Most successful applications have 2-4 specific aims

5 Dont bite off more than you can chew A small focused project is generally better received than a difftise multifaceted project

6 Be certain that all aims are related Have someone read them for clarity and cohesiveness

7 Focus on aims where you have good supporting preliminary data and scientific expertise

RESEARCH PLAN PART B

BACKGROUND AND SIGNIFICENCE

Purpose The purpose of the background and significance section is to state the problem to be investigated the rationale for the proposed research the current state of knowledge relevant to the proposal and the potential contribution of this research to the problem(s) addressed

Recommended Length Approximately 3 pages

Content The background and significance section should cover n the rationale for the proposed project n the state of existing knowledge including literature citations and highlights of relevant data n gaps that the project is intended to fill

Page 4 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

3202002httpdeainfoncinihgovextraextdocsgntapphtm

Suggestions 1 Make a compelling case for your proposed research project Why is the topic important Why

are the specific research questions important How are the researchers qualified to address these

2 Establish familiarity with recent research findings Avoid outdated research Use citations not only as support for specific statements but also to establish familiarity with all of the relevant publications and points of view Your application may well be reviewed by someone worlcing in your field If their contributions and their point of view are not mentioned they are not iikely to review your application sympathetically

3 Make sure the citations are specifically related to the proposed research Cite and paraphrase correctly and constructively

4 Highlight why research findings are important beyond the confines of a specific project ie how can the results be applied to further research in this field or related areas

5 Stress any innovations in-experimental methods (eg new strategies- research methods used interventions proposed)

RESEARCH PLAN PART C

PRELIMINARY RESULTSPROGRESS REPORT

Purpose The purpose of the preliminary results section is to describe prior work by the investigators relevant to the proposed project In a new application the preliminary results are important to establish the experience and capabilities of the applicant investigators in the area of proposed research and to provide experimental support for the hypothesis and the research design This section is not mandatory for new applications but it is virtually impossible to obtain a favorable review without strong preliminary data In a competing renewal application this section becomes a progress report describing studies performed during the last grant period

Recommended Length The recommended length of the preliminary resultsprogress report section is 6-8 pages

Content The preliminary results section should include the following n most importantly a description of recent studies by the applicant investigators that establish the

feasibility and importance of the proposed project n a brief description of older published studies by the applicant that provide important

background information relevant to the proposed project n results of previous studies by the applicant not directly relevant to the proposed project if they

are needed to establish the applicants competence and experience with the experimental techniques to be used in the proposed project

Suggestions 1 All Tables and Figures necessary for the presentation of preliminary results must be included in

this section of the application Full-size glossy photographs of materials such as electron micrographs gels etc may be included in the appendix but only if a photocopy (reduced in size as appropriate) is included in the body of the Research Plan

2 Figures and Figure legends must be legible There are specific limits on type size given in the application instructions but beyond these rules the critical factor is whether the data are legible and convincing to the reviewers

3 Do not dwell on results already published Summarize the critical findings in the text and include

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reprints of the full article in the appendix Up to 10 publications can be included with the appendix material

RESEARCH PLAN PART D

RESEARCH DESIGN AND METHODS

Purpose The purpose of the research design and methods section is to describe how the research will be carried out This section is crucial to how favorably an application is reviewed

Recommended Length The maximum recommended length of the research design and methods section is 20 pages

Content The research design and methods section should include the following n an overview of the experimental design n a detailed description of specific methods to be employed to accomplish the specific aims n a detailed discussion of the way in which the results will be collected analyzed and interpreted n a projected sequence or timetable (work plan) n a description of any new methodology used and why it represents an improvement over the

existing ones n a discussion of potential difficulties and limitations and how these will be overcome or mitigated n expected results and alternative approaches that will be used if unexpected results are found n precautions to be exercised with respect to any procedures situations or materials that may be

hazardous to personnel or human subjects

Suggestions Number the sections in this part of the application to correspond to the numbers of the Specific Aims

1 Give sufficient detail Do not assume that the reviewers will know how you intend to proceed

2 Avoid excessive experimental detail by referring to publications that describe the methods to be employed Publications cited should be by the applicants if at all possible Citing someone elses publication establishes that you know what method to use but citing your own (or that of a collaborator) establishes that the applicant personnel are experienced with the necessary techniques

3 If relevant explain why one approach or method will be used in preference to others This establishes that the alternatives were not simply overlooked Give not only the how but the why

4 If employing a complex technology for the fast time take extra care to demonstrate familiarity with the experimental details and potential pitfalls Add a coinvestigator or consultant experienced with the technology if necessary

5 Document proposed collaborations and offers of materials or reagents of restricted availability with letters from the individuals involved

BUDGET AND JUSTIFICATION Purpose The purpose of the budget and justification is to present and justify all expenses required to achieve project aims and objectives For multi-institutional applications there must be a separate

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budget for each subcontractor or consortium member

Recommended Length Special forms are provided for the budget and justitication Read the instructions carefully If there is a coinvestigator at another institution for whom funds are requested be sure to include their budget

Content The budget and justification should cover the following n personnel n consultants n equipment n supplies n travel and n other expenses eg animal maintenance

Suggestions

1 Be realistic Both padding and deliberately underbudgeting reflect naivete which will be recognized by reviewers

2 Provide brief descriptions of duties for all positions listed in the budget with the percentage of effort requested each year and any anticipated flucations Special skills or accomplishments of a designated person may be included if not discussed elsewhere

3 If possible try to identify specific individuals for each position requested To be named personnel are very often deleted by reviewers

4 Justify all equipment purchases The proposed acquisition of major pieces of equipment is likely to be scrutinized very carefully Details are important especially for non-project specific equipment eg FAX machine and computers

5 Break out supply costs into major categories (reagents disposables etc) Provide special justification for any unusual expenses requested

6 Detail and justify travel costs Make sure they reflect cuffent fares and lodging costs and that proposed travel is project related

7 Explain any year-to-year fluctuations in the budget including the level of effort of personnel especially if they can not be attributed to routine salary increases Changes should parallel the research plan and project aims

8 Check indirect costs Some institutions have on-campus and off -campus rates

9 Be complete but concise There are no page limits in this section

10 Provide adequate justification for the need to use outside consultants if applicable

11 The budget must be approved by the grantee institution business office before they can sign the application

12 If applicable provide documentation of institutional rates for animal maintenance and acquisition Exceptionally large numbers of animals will need detailed justification

13 Prorate service contracts to percentage of time equipment is used for this project

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ASSURANCES Purpose The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines

Recommended Length A special form must be completed for the assurances section See page B of the PHS 398 application

Content The assurances cover n human subjects n vertebrate animals n inventions and patents n debarment and suspension n drug-free workplace n lobbying n delinquent Federal debt n misconduct in science n civil rights n handicapped individuals n sex discrimination and n age discrimination

Suggestions 1 Be familiar with assurances certifications and requirements for complying with these

regulations

2 Begin to obtain assurances early since they tend to require the cooperation of different institutions

3 Check your institutions grants management office for additional requirements Different institutions follow different procedures and timelines

HUMAN SUBJECTS Purpose The purpose of this section describing the involvement of human subjects is to ensure the protection of the rights and welfare of people who participate in research projects

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section If an exemption has been designated in item 4a on the face page enough detail still must be provided to allow the determination of the appropriateness of the exemption If no exemption is claimed there are six points which must be addressed in this section A full description of these points can be found on page 22 of the PHS 398 application package Be thorough in addressing these six areas

All research applications involving human subjects must address the issue of inclusion of women and minorities in the subject population A justification is required if there is limited representation of women and minorities Peer review and NIH program staff will consider this justification in their evaluation of your application Failure to address this issue will impose a bar making any award until all the concems raised by the IRG have been resolved

The assurance of compliance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 4b of the face page as must the IRB approval date

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Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving human subjects requires a current review by your Institutional Review Board (IRB) Be sure to provide the most recent review date for your project

3 You must provide information on the inclusion of women and minorities in the study population

VERTEBRATE ANIMALS Purpose The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section There are five points which must be addressed in this section A full description of these points can be found on page 23 of the PHS 398 application package Be thorough in addressing these five areas Failure to address any of these areas will delay any award until these issues have been resolved

The animal welfare assurance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 5b of the face page as must the IACUC approval date

Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC) Be sure to provide the most recent review date for your project

3 Be sure the number of animals proposed is realistic

4 Justify all animal expenses

RESOURCES AND ENVIRONMENT Purpose The purpose of the resources and environment section is to describe the resources facilities and support available to the researcher

Recommended Length A special form is provided for the resources and environment section

Suggestions 1 Make sure the resources and environment section addresses all requirements of the proposed

research plan

2 Justify any reliance on resources external to the research

3 Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem

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4 Make certain your resources and budget requests are consistent

OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

2 Use basic English and avoid jargon

3 Make sure all acronyms are spelled out when used initially

4 Type single-spaced and stay within the margins

5 Observe the type size and page limitations strictly do not use a small font

6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

9 List all citations (six pages maximum) at the end of the research plan

10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

11 Have an outside reader review the proposal for clarity and consistency

12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

13 Be consistent with terms references and forrn writing style

14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

16 Make sure all the check-box items on page II of the PHS 398 application are completed

17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

DEA Home

created 27sep95 Lorrie Smith revised 02apr98

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Home | Search | Sitemap | Contact

About NICHD | News amp Events | Health Information amp Media | Funding by NICHD | Intramural Research Epidemiology Statistics amp Prevention | Employment amp Fellowships | Research Resources

Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

The following slides were presented at the University of Louisville on September 23 and 24 1999

Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

Slides Table of Contents

l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

Page 1 of 1How to Apply for NIH Funding (slides)

3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

Third Edition amended August 30 2001

The Original How to Write a Research Grant Application

Contents

Strategy for Getting an NIH Grant 2

Writing an Application for a Research Project Grant 3

I Before You Begin 4

II Application Contents 5

III Developing Your Research Plan 6

IV Application Contents Other Than the Research Plan 15

V Writing and Formatting 18

VI Submitting Your Grant Application 20

VII Problems and Concerns Commonly Cited by Reviewers 21

VIII Referral and Assignment of the Application 23

IX Review of Research Project Applications 24

X How Funding Is Decided 27

XI When You Have Not Obtained Funding 29

XII When Your Application Is Approved for Funding 32

Checklists 35

Strategy for Getting an NIH Grant

1 Assess competition in the field

2 Know the level of resources needed to compete

- do an organizational assessment

- look for opportunities to build research with support from various sources

- get a mentor

3 Be willing to change yourself your projects your career

4 Know the opportunities in the field for

- collaboration with a known laboratory or mentor

- carving out a niche

5 Find out which NIH institutes supporting research in your area are seeking applications

- go to our list of program announcements (PA) on the Web and requests for applications (RFA)

- discuss your ideas with Institute program staff See NIAIDs program and staff listing

6 Make sure you and your collaborators are properly trained for the research

7 Closely examine grant applications from successful grantees

8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

9 Have several experienced grantees critique your application

10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

Writing an Application for a Research Project Grant

There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

Eight Basic Questions Reviewers Ask

1 How high are the intellectual quality and merit of the study

2 What is its potential impact

3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

4 Is the hypothesis valid and have you presented evidence supporting it

5 Are the aims logical

6 Are the procedures appropriate adequate and feasible for the research

7 Are the investigators qualified Have they shown competence credentials and experience

8 Are the facilities adequate and the environment conducive to the research

Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

I Before You Begin

Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

Developing the Hypothesis

Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

State your hypothesis in both the specific aims section of the research plan and the abstract

II Application Contents

Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

III Developing Your Research Plan

A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

- Your application should be based on a strong hypothesis

- Be sure your project has a coherent direction

- Keep the sections of the plan well coordinated and clearly related to the central focus

- Emphasize mechanism A good grant application asks questions about biological mechanisms

- Dont be overly ambitious your plan should be based on a feasible timetable

- Specific aims and experiments should relate directly to the hypothesis to be tested

A Specific Aims

Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

B Background and Significance

Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

Identify the next logical stage of research beyond your current application

C Preliminary StudiesProgress Report

By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

D Research Design and Methods

Describe the experimental design and procedures in detail and give a rationale for their use

Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

advantageous to the research you propose to do

More and more applicants are including colored charts graphs and photographs in their applications

Approach

State why you chose your approach or approaches as opposed to others

If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

Consider the limitations of each approach and how it may affect your results and the data generated

Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

Results

Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

Describe your proposed statistical methods for analyzing the data you plan to collect

Define the criteria for evaluating the success or failure of a specific test

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 6: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

RESEARCH PLAN PART A

SPECIFIC AIMS

Purpose The purpose of the specific aims is to describe concisely and realistically what the proposed research is intended to accomplish

Recommended Length The recommended length of the specific aims is one page

Content The specific aims should cover n broad long-term goals n the hypothesis or hypotheses to be tested and n specific time-phased research objectives

Suggestions

1 Generally the Specific Aims section should begin with a brief narrative describing the long-term goals of the project and the hypothesis guiding the research This is followed by a numbered list of the Aims

2 State the hypothesis clearly Make sure it is understandable testable and adequately supported by citations in the Background and by data in the Preliminary Results Sections Be sure to explain how the results to be obtained will be used to test the hypothesis

3 Show that the objectives are attainable within the stated time frame

4 Be as brief and specific as possible For clarity each aim should consist of only one sentence Use a brief paracraph under each aim if detail is needed Most successful applications have 2-4 specific aims

5 Dont bite off more than you can chew A small focused project is generally better received than a difftise multifaceted project

6 Be certain that all aims are related Have someone read them for clarity and cohesiveness

7 Focus on aims where you have good supporting preliminary data and scientific expertise

RESEARCH PLAN PART B

BACKGROUND AND SIGNIFICENCE

Purpose The purpose of the background and significance section is to state the problem to be investigated the rationale for the proposed research the current state of knowledge relevant to the proposal and the potential contribution of this research to the problem(s) addressed

Recommended Length Approximately 3 pages

Content The background and significance section should cover n the rationale for the proposed project n the state of existing knowledge including literature citations and highlights of relevant data n gaps that the project is intended to fill

Page 4 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

3202002httpdeainfoncinihgovextraextdocsgntapphtm

Suggestions 1 Make a compelling case for your proposed research project Why is the topic important Why

are the specific research questions important How are the researchers qualified to address these

2 Establish familiarity with recent research findings Avoid outdated research Use citations not only as support for specific statements but also to establish familiarity with all of the relevant publications and points of view Your application may well be reviewed by someone worlcing in your field If their contributions and their point of view are not mentioned they are not iikely to review your application sympathetically

3 Make sure the citations are specifically related to the proposed research Cite and paraphrase correctly and constructively

4 Highlight why research findings are important beyond the confines of a specific project ie how can the results be applied to further research in this field or related areas

5 Stress any innovations in-experimental methods (eg new strategies- research methods used interventions proposed)

RESEARCH PLAN PART C

PRELIMINARY RESULTSPROGRESS REPORT

Purpose The purpose of the preliminary results section is to describe prior work by the investigators relevant to the proposed project In a new application the preliminary results are important to establish the experience and capabilities of the applicant investigators in the area of proposed research and to provide experimental support for the hypothesis and the research design This section is not mandatory for new applications but it is virtually impossible to obtain a favorable review without strong preliminary data In a competing renewal application this section becomes a progress report describing studies performed during the last grant period

Recommended Length The recommended length of the preliminary resultsprogress report section is 6-8 pages

Content The preliminary results section should include the following n most importantly a description of recent studies by the applicant investigators that establish the

feasibility and importance of the proposed project n a brief description of older published studies by the applicant that provide important

background information relevant to the proposed project n results of previous studies by the applicant not directly relevant to the proposed project if they

are needed to establish the applicants competence and experience with the experimental techniques to be used in the proposed project

Suggestions 1 All Tables and Figures necessary for the presentation of preliminary results must be included in

this section of the application Full-size glossy photographs of materials such as electron micrographs gels etc may be included in the appendix but only if a photocopy (reduced in size as appropriate) is included in the body of the Research Plan

2 Figures and Figure legends must be legible There are specific limits on type size given in the application instructions but beyond these rules the critical factor is whether the data are legible and convincing to the reviewers

3 Do not dwell on results already published Summarize the critical findings in the text and include

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reprints of the full article in the appendix Up to 10 publications can be included with the appendix material

RESEARCH PLAN PART D

RESEARCH DESIGN AND METHODS

Purpose The purpose of the research design and methods section is to describe how the research will be carried out This section is crucial to how favorably an application is reviewed

Recommended Length The maximum recommended length of the research design and methods section is 20 pages

Content The research design and methods section should include the following n an overview of the experimental design n a detailed description of specific methods to be employed to accomplish the specific aims n a detailed discussion of the way in which the results will be collected analyzed and interpreted n a projected sequence or timetable (work plan) n a description of any new methodology used and why it represents an improvement over the

existing ones n a discussion of potential difficulties and limitations and how these will be overcome or mitigated n expected results and alternative approaches that will be used if unexpected results are found n precautions to be exercised with respect to any procedures situations or materials that may be

hazardous to personnel or human subjects

Suggestions Number the sections in this part of the application to correspond to the numbers of the Specific Aims

1 Give sufficient detail Do not assume that the reviewers will know how you intend to proceed

2 Avoid excessive experimental detail by referring to publications that describe the methods to be employed Publications cited should be by the applicants if at all possible Citing someone elses publication establishes that you know what method to use but citing your own (or that of a collaborator) establishes that the applicant personnel are experienced with the necessary techniques

3 If relevant explain why one approach or method will be used in preference to others This establishes that the alternatives were not simply overlooked Give not only the how but the why

4 If employing a complex technology for the fast time take extra care to demonstrate familiarity with the experimental details and potential pitfalls Add a coinvestigator or consultant experienced with the technology if necessary

5 Document proposed collaborations and offers of materials or reagents of restricted availability with letters from the individuals involved

BUDGET AND JUSTIFICATION Purpose The purpose of the budget and justification is to present and justify all expenses required to achieve project aims and objectives For multi-institutional applications there must be a separate

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budget for each subcontractor or consortium member

Recommended Length Special forms are provided for the budget and justitication Read the instructions carefully If there is a coinvestigator at another institution for whom funds are requested be sure to include their budget

Content The budget and justification should cover the following n personnel n consultants n equipment n supplies n travel and n other expenses eg animal maintenance

Suggestions

1 Be realistic Both padding and deliberately underbudgeting reflect naivete which will be recognized by reviewers

2 Provide brief descriptions of duties for all positions listed in the budget with the percentage of effort requested each year and any anticipated flucations Special skills or accomplishments of a designated person may be included if not discussed elsewhere

3 If possible try to identify specific individuals for each position requested To be named personnel are very often deleted by reviewers

4 Justify all equipment purchases The proposed acquisition of major pieces of equipment is likely to be scrutinized very carefully Details are important especially for non-project specific equipment eg FAX machine and computers

5 Break out supply costs into major categories (reagents disposables etc) Provide special justification for any unusual expenses requested

6 Detail and justify travel costs Make sure they reflect cuffent fares and lodging costs and that proposed travel is project related

7 Explain any year-to-year fluctuations in the budget including the level of effort of personnel especially if they can not be attributed to routine salary increases Changes should parallel the research plan and project aims

8 Check indirect costs Some institutions have on-campus and off -campus rates

9 Be complete but concise There are no page limits in this section

10 Provide adequate justification for the need to use outside consultants if applicable

11 The budget must be approved by the grantee institution business office before they can sign the application

12 If applicable provide documentation of institutional rates for animal maintenance and acquisition Exceptionally large numbers of animals will need detailed justification

13 Prorate service contracts to percentage of time equipment is used for this project

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ASSURANCES Purpose The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines

Recommended Length A special form must be completed for the assurances section See page B of the PHS 398 application

Content The assurances cover n human subjects n vertebrate animals n inventions and patents n debarment and suspension n drug-free workplace n lobbying n delinquent Federal debt n misconduct in science n civil rights n handicapped individuals n sex discrimination and n age discrimination

Suggestions 1 Be familiar with assurances certifications and requirements for complying with these

regulations

2 Begin to obtain assurances early since they tend to require the cooperation of different institutions

3 Check your institutions grants management office for additional requirements Different institutions follow different procedures and timelines

HUMAN SUBJECTS Purpose The purpose of this section describing the involvement of human subjects is to ensure the protection of the rights and welfare of people who participate in research projects

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section If an exemption has been designated in item 4a on the face page enough detail still must be provided to allow the determination of the appropriateness of the exemption If no exemption is claimed there are six points which must be addressed in this section A full description of these points can be found on page 22 of the PHS 398 application package Be thorough in addressing these six areas

All research applications involving human subjects must address the issue of inclusion of women and minorities in the subject population A justification is required if there is limited representation of women and minorities Peer review and NIH program staff will consider this justification in their evaluation of your application Failure to address this issue will impose a bar making any award until all the concems raised by the IRG have been resolved

The assurance of compliance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 4b of the face page as must the IRB approval date

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Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving human subjects requires a current review by your Institutional Review Board (IRB) Be sure to provide the most recent review date for your project

3 You must provide information on the inclusion of women and minorities in the study population

VERTEBRATE ANIMALS Purpose The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section There are five points which must be addressed in this section A full description of these points can be found on page 23 of the PHS 398 application package Be thorough in addressing these five areas Failure to address any of these areas will delay any award until these issues have been resolved

The animal welfare assurance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 5b of the face page as must the IACUC approval date

Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC) Be sure to provide the most recent review date for your project

3 Be sure the number of animals proposed is realistic

4 Justify all animal expenses

RESOURCES AND ENVIRONMENT Purpose The purpose of the resources and environment section is to describe the resources facilities and support available to the researcher

Recommended Length A special form is provided for the resources and environment section

Suggestions 1 Make sure the resources and environment section addresses all requirements of the proposed

research plan

2 Justify any reliance on resources external to the research

3 Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem

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4 Make certain your resources and budget requests are consistent

OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

2 Use basic English and avoid jargon

3 Make sure all acronyms are spelled out when used initially

4 Type single-spaced and stay within the margins

5 Observe the type size and page limitations strictly do not use a small font

6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

9 List all citations (six pages maximum) at the end of the research plan

10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

11 Have an outside reader review the proposal for clarity and consistency

12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

13 Be consistent with terms references and forrn writing style

14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

16 Make sure all the check-box items on page II of the PHS 398 application are completed

17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

DEA Home

created 27sep95 Lorrie Smith revised 02apr98

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Home | Search | Sitemap | Contact

About NICHD | News amp Events | Health Information amp Media | Funding by NICHD | Intramural Research Epidemiology Statistics amp Prevention | Employment amp Fellowships | Research Resources

Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

The following slides were presented at the University of Louisville on September 23 and 24 1999

Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

Slides Table of Contents

l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

Page 1 of 1How to Apply for NIH Funding (slides)

3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

Third Edition amended August 30 2001

The Original How to Write a Research Grant Application

Contents

Strategy for Getting an NIH Grant 2

Writing an Application for a Research Project Grant 3

I Before You Begin 4

II Application Contents 5

III Developing Your Research Plan 6

IV Application Contents Other Than the Research Plan 15

V Writing and Formatting 18

VI Submitting Your Grant Application 20

VII Problems and Concerns Commonly Cited by Reviewers 21

VIII Referral and Assignment of the Application 23

IX Review of Research Project Applications 24

X How Funding Is Decided 27

XI When You Have Not Obtained Funding 29

XII When Your Application Is Approved for Funding 32

Checklists 35

Strategy for Getting an NIH Grant

1 Assess competition in the field

2 Know the level of resources needed to compete

- do an organizational assessment

- look for opportunities to build research with support from various sources

- get a mentor

3 Be willing to change yourself your projects your career

4 Know the opportunities in the field for

- collaboration with a known laboratory or mentor

- carving out a niche

5 Find out which NIH institutes supporting research in your area are seeking applications

- go to our list of program announcements (PA) on the Web and requests for applications (RFA)

- discuss your ideas with Institute program staff See NIAIDs program and staff listing

6 Make sure you and your collaborators are properly trained for the research

7 Closely examine grant applications from successful grantees

8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

9 Have several experienced grantees critique your application

10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

Writing an Application for a Research Project Grant

There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

Eight Basic Questions Reviewers Ask

1 How high are the intellectual quality and merit of the study

2 What is its potential impact

3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

4 Is the hypothesis valid and have you presented evidence supporting it

5 Are the aims logical

6 Are the procedures appropriate adequate and feasible for the research

7 Are the investigators qualified Have they shown competence credentials and experience

8 Are the facilities adequate and the environment conducive to the research

Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

I Before You Begin

Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

Developing the Hypothesis

Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

State your hypothesis in both the specific aims section of the research plan and the abstract

II Application Contents

Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

III Developing Your Research Plan

A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

- Your application should be based on a strong hypothesis

- Be sure your project has a coherent direction

- Keep the sections of the plan well coordinated and clearly related to the central focus

- Emphasize mechanism A good grant application asks questions about biological mechanisms

- Dont be overly ambitious your plan should be based on a feasible timetable

- Specific aims and experiments should relate directly to the hypothesis to be tested

A Specific Aims

Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

B Background and Significance

Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

Identify the next logical stage of research beyond your current application

C Preliminary StudiesProgress Report

By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

D Research Design and Methods

Describe the experimental design and procedures in detail and give a rationale for their use

Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

advantageous to the research you propose to do

More and more applicants are including colored charts graphs and photographs in their applications

Approach

State why you chose your approach or approaches as opposed to others

If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

Consider the limitations of each approach and how it may affect your results and the data generated

Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

Results

Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

Describe your proposed statistical methods for analyzing the data you plan to collect

Define the criteria for evaluating the success or failure of a specific test

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 7: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

Suggestions 1 Make a compelling case for your proposed research project Why is the topic important Why

are the specific research questions important How are the researchers qualified to address these

2 Establish familiarity with recent research findings Avoid outdated research Use citations not only as support for specific statements but also to establish familiarity with all of the relevant publications and points of view Your application may well be reviewed by someone worlcing in your field If their contributions and their point of view are not mentioned they are not iikely to review your application sympathetically

3 Make sure the citations are specifically related to the proposed research Cite and paraphrase correctly and constructively

4 Highlight why research findings are important beyond the confines of a specific project ie how can the results be applied to further research in this field or related areas

5 Stress any innovations in-experimental methods (eg new strategies- research methods used interventions proposed)

RESEARCH PLAN PART C

PRELIMINARY RESULTSPROGRESS REPORT

Purpose The purpose of the preliminary results section is to describe prior work by the investigators relevant to the proposed project In a new application the preliminary results are important to establish the experience and capabilities of the applicant investigators in the area of proposed research and to provide experimental support for the hypothesis and the research design This section is not mandatory for new applications but it is virtually impossible to obtain a favorable review without strong preliminary data In a competing renewal application this section becomes a progress report describing studies performed during the last grant period

Recommended Length The recommended length of the preliminary resultsprogress report section is 6-8 pages

Content The preliminary results section should include the following n most importantly a description of recent studies by the applicant investigators that establish the

feasibility and importance of the proposed project n a brief description of older published studies by the applicant that provide important

background information relevant to the proposed project n results of previous studies by the applicant not directly relevant to the proposed project if they

are needed to establish the applicants competence and experience with the experimental techniques to be used in the proposed project

Suggestions 1 All Tables and Figures necessary for the presentation of preliminary results must be included in

this section of the application Full-size glossy photographs of materials such as electron micrographs gels etc may be included in the appendix but only if a photocopy (reduced in size as appropriate) is included in the body of the Research Plan

2 Figures and Figure legends must be legible There are specific limits on type size given in the application instructions but beyond these rules the critical factor is whether the data are legible and convincing to the reviewers

3 Do not dwell on results already published Summarize the critical findings in the text and include

Page 5 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

3202002httpdeainfoncinihgovextraextdocsgntapphtm

reprints of the full article in the appendix Up to 10 publications can be included with the appendix material

RESEARCH PLAN PART D

RESEARCH DESIGN AND METHODS

Purpose The purpose of the research design and methods section is to describe how the research will be carried out This section is crucial to how favorably an application is reviewed

Recommended Length The maximum recommended length of the research design and methods section is 20 pages

Content The research design and methods section should include the following n an overview of the experimental design n a detailed description of specific methods to be employed to accomplish the specific aims n a detailed discussion of the way in which the results will be collected analyzed and interpreted n a projected sequence or timetable (work plan) n a description of any new methodology used and why it represents an improvement over the

existing ones n a discussion of potential difficulties and limitations and how these will be overcome or mitigated n expected results and alternative approaches that will be used if unexpected results are found n precautions to be exercised with respect to any procedures situations or materials that may be

hazardous to personnel or human subjects

Suggestions Number the sections in this part of the application to correspond to the numbers of the Specific Aims

1 Give sufficient detail Do not assume that the reviewers will know how you intend to proceed

2 Avoid excessive experimental detail by referring to publications that describe the methods to be employed Publications cited should be by the applicants if at all possible Citing someone elses publication establishes that you know what method to use but citing your own (or that of a collaborator) establishes that the applicant personnel are experienced with the necessary techniques

3 If relevant explain why one approach or method will be used in preference to others This establishes that the alternatives were not simply overlooked Give not only the how but the why

4 If employing a complex technology for the fast time take extra care to demonstrate familiarity with the experimental details and potential pitfalls Add a coinvestigator or consultant experienced with the technology if necessary

5 Document proposed collaborations and offers of materials or reagents of restricted availability with letters from the individuals involved

BUDGET AND JUSTIFICATION Purpose The purpose of the budget and justification is to present and justify all expenses required to achieve project aims and objectives For multi-institutional applications there must be a separate

Page 6 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

3202002httpdeainfoncinihgovextraextdocsgntapphtm

budget for each subcontractor or consortium member

Recommended Length Special forms are provided for the budget and justitication Read the instructions carefully If there is a coinvestigator at another institution for whom funds are requested be sure to include their budget

Content The budget and justification should cover the following n personnel n consultants n equipment n supplies n travel and n other expenses eg animal maintenance

Suggestions

1 Be realistic Both padding and deliberately underbudgeting reflect naivete which will be recognized by reviewers

2 Provide brief descriptions of duties for all positions listed in the budget with the percentage of effort requested each year and any anticipated flucations Special skills or accomplishments of a designated person may be included if not discussed elsewhere

3 If possible try to identify specific individuals for each position requested To be named personnel are very often deleted by reviewers

4 Justify all equipment purchases The proposed acquisition of major pieces of equipment is likely to be scrutinized very carefully Details are important especially for non-project specific equipment eg FAX machine and computers

5 Break out supply costs into major categories (reagents disposables etc) Provide special justification for any unusual expenses requested

6 Detail and justify travel costs Make sure they reflect cuffent fares and lodging costs and that proposed travel is project related

7 Explain any year-to-year fluctuations in the budget including the level of effort of personnel especially if they can not be attributed to routine salary increases Changes should parallel the research plan and project aims

8 Check indirect costs Some institutions have on-campus and off -campus rates

9 Be complete but concise There are no page limits in this section

10 Provide adequate justification for the need to use outside consultants if applicable

11 The budget must be approved by the grantee institution business office before they can sign the application

12 If applicable provide documentation of institutional rates for animal maintenance and acquisition Exceptionally large numbers of animals will need detailed justification

13 Prorate service contracts to percentage of time equipment is used for this project

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ASSURANCES Purpose The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines

Recommended Length A special form must be completed for the assurances section See page B of the PHS 398 application

Content The assurances cover n human subjects n vertebrate animals n inventions and patents n debarment and suspension n drug-free workplace n lobbying n delinquent Federal debt n misconduct in science n civil rights n handicapped individuals n sex discrimination and n age discrimination

Suggestions 1 Be familiar with assurances certifications and requirements for complying with these

regulations

2 Begin to obtain assurances early since they tend to require the cooperation of different institutions

3 Check your institutions grants management office for additional requirements Different institutions follow different procedures and timelines

HUMAN SUBJECTS Purpose The purpose of this section describing the involvement of human subjects is to ensure the protection of the rights and welfare of people who participate in research projects

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section If an exemption has been designated in item 4a on the face page enough detail still must be provided to allow the determination of the appropriateness of the exemption If no exemption is claimed there are six points which must be addressed in this section A full description of these points can be found on page 22 of the PHS 398 application package Be thorough in addressing these six areas

All research applications involving human subjects must address the issue of inclusion of women and minorities in the subject population A justification is required if there is limited representation of women and minorities Peer review and NIH program staff will consider this justification in their evaluation of your application Failure to address this issue will impose a bar making any award until all the concems raised by the IRG have been resolved

The assurance of compliance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 4b of the face page as must the IRB approval date

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Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving human subjects requires a current review by your Institutional Review Board (IRB) Be sure to provide the most recent review date for your project

3 You must provide information on the inclusion of women and minorities in the study population

VERTEBRATE ANIMALS Purpose The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section There are five points which must be addressed in this section A full description of these points can be found on page 23 of the PHS 398 application package Be thorough in addressing these five areas Failure to address any of these areas will delay any award until these issues have been resolved

The animal welfare assurance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 5b of the face page as must the IACUC approval date

Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC) Be sure to provide the most recent review date for your project

3 Be sure the number of animals proposed is realistic

4 Justify all animal expenses

RESOURCES AND ENVIRONMENT Purpose The purpose of the resources and environment section is to describe the resources facilities and support available to the researcher

Recommended Length A special form is provided for the resources and environment section

Suggestions 1 Make sure the resources and environment section addresses all requirements of the proposed

research plan

2 Justify any reliance on resources external to the research

3 Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem

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4 Make certain your resources and budget requests are consistent

OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

2 Use basic English and avoid jargon

3 Make sure all acronyms are spelled out when used initially

4 Type single-spaced and stay within the margins

5 Observe the type size and page limitations strictly do not use a small font

6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

9 List all citations (six pages maximum) at the end of the research plan

10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

11 Have an outside reader review the proposal for clarity and consistency

12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

13 Be consistent with terms references and forrn writing style

14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

16 Make sure all the check-box items on page II of the PHS 398 application are completed

17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

DEA Home

created 27sep95 Lorrie Smith revised 02apr98

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Home | Search | Sitemap | Contact

About NICHD | News amp Events | Health Information amp Media | Funding by NICHD | Intramural Research Epidemiology Statistics amp Prevention | Employment amp Fellowships | Research Resources

Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

The following slides were presented at the University of Louisville on September 23 and 24 1999

Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

Slides Table of Contents

l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

Page 1 of 1How to Apply for NIH Funding (slides)

3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

Third Edition amended August 30 2001

The Original How to Write a Research Grant Application

Contents

Strategy for Getting an NIH Grant 2

Writing an Application for a Research Project Grant 3

I Before You Begin 4

II Application Contents 5

III Developing Your Research Plan 6

IV Application Contents Other Than the Research Plan 15

V Writing and Formatting 18

VI Submitting Your Grant Application 20

VII Problems and Concerns Commonly Cited by Reviewers 21

VIII Referral and Assignment of the Application 23

IX Review of Research Project Applications 24

X How Funding Is Decided 27

XI When You Have Not Obtained Funding 29

XII When Your Application Is Approved for Funding 32

Checklists 35

Strategy for Getting an NIH Grant

1 Assess competition in the field

2 Know the level of resources needed to compete

- do an organizational assessment

- look for opportunities to build research with support from various sources

- get a mentor

3 Be willing to change yourself your projects your career

4 Know the opportunities in the field for

- collaboration with a known laboratory or mentor

- carving out a niche

5 Find out which NIH institutes supporting research in your area are seeking applications

- go to our list of program announcements (PA) on the Web and requests for applications (RFA)

- discuss your ideas with Institute program staff See NIAIDs program and staff listing

6 Make sure you and your collaborators are properly trained for the research

7 Closely examine grant applications from successful grantees

8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

9 Have several experienced grantees critique your application

10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

Writing an Application for a Research Project Grant

There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

Eight Basic Questions Reviewers Ask

1 How high are the intellectual quality and merit of the study

2 What is its potential impact

3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

4 Is the hypothesis valid and have you presented evidence supporting it

5 Are the aims logical

6 Are the procedures appropriate adequate and feasible for the research

7 Are the investigators qualified Have they shown competence credentials and experience

8 Are the facilities adequate and the environment conducive to the research

Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

I Before You Begin

Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

Developing the Hypothesis

Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

State your hypothesis in both the specific aims section of the research plan and the abstract

II Application Contents

Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

III Developing Your Research Plan

A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

- Your application should be based on a strong hypothesis

- Be sure your project has a coherent direction

- Keep the sections of the plan well coordinated and clearly related to the central focus

- Emphasize mechanism A good grant application asks questions about biological mechanisms

- Dont be overly ambitious your plan should be based on a feasible timetable

- Specific aims and experiments should relate directly to the hypothesis to be tested

A Specific Aims

Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

B Background and Significance

Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

Identify the next logical stage of research beyond your current application

C Preliminary StudiesProgress Report

By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

D Research Design and Methods

Describe the experimental design and procedures in detail and give a rationale for their use

Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

advantageous to the research you propose to do

More and more applicants are including colored charts graphs and photographs in their applications

Approach

State why you chose your approach or approaches as opposed to others

If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

Consider the limitations of each approach and how it may affect your results and the data generated

Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

Results

Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

Describe your proposed statistical methods for analyzing the data you plan to collect

Define the criteria for evaluating the success or failure of a specific test

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 8: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

reprints of the full article in the appendix Up to 10 publications can be included with the appendix material

RESEARCH PLAN PART D

RESEARCH DESIGN AND METHODS

Purpose The purpose of the research design and methods section is to describe how the research will be carried out This section is crucial to how favorably an application is reviewed

Recommended Length The maximum recommended length of the research design and methods section is 20 pages

Content The research design and methods section should include the following n an overview of the experimental design n a detailed description of specific methods to be employed to accomplish the specific aims n a detailed discussion of the way in which the results will be collected analyzed and interpreted n a projected sequence or timetable (work plan) n a description of any new methodology used and why it represents an improvement over the

existing ones n a discussion of potential difficulties and limitations and how these will be overcome or mitigated n expected results and alternative approaches that will be used if unexpected results are found n precautions to be exercised with respect to any procedures situations or materials that may be

hazardous to personnel or human subjects

Suggestions Number the sections in this part of the application to correspond to the numbers of the Specific Aims

1 Give sufficient detail Do not assume that the reviewers will know how you intend to proceed

2 Avoid excessive experimental detail by referring to publications that describe the methods to be employed Publications cited should be by the applicants if at all possible Citing someone elses publication establishes that you know what method to use but citing your own (or that of a collaborator) establishes that the applicant personnel are experienced with the necessary techniques

3 If relevant explain why one approach or method will be used in preference to others This establishes that the alternatives were not simply overlooked Give not only the how but the why

4 If employing a complex technology for the fast time take extra care to demonstrate familiarity with the experimental details and potential pitfalls Add a coinvestigator or consultant experienced with the technology if necessary

5 Document proposed collaborations and offers of materials or reagents of restricted availability with letters from the individuals involved

BUDGET AND JUSTIFICATION Purpose The purpose of the budget and justification is to present and justify all expenses required to achieve project aims and objectives For multi-institutional applications there must be a separate

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budget for each subcontractor or consortium member

Recommended Length Special forms are provided for the budget and justitication Read the instructions carefully If there is a coinvestigator at another institution for whom funds are requested be sure to include their budget

Content The budget and justification should cover the following n personnel n consultants n equipment n supplies n travel and n other expenses eg animal maintenance

Suggestions

1 Be realistic Both padding and deliberately underbudgeting reflect naivete which will be recognized by reviewers

2 Provide brief descriptions of duties for all positions listed in the budget with the percentage of effort requested each year and any anticipated flucations Special skills or accomplishments of a designated person may be included if not discussed elsewhere

3 If possible try to identify specific individuals for each position requested To be named personnel are very often deleted by reviewers

4 Justify all equipment purchases The proposed acquisition of major pieces of equipment is likely to be scrutinized very carefully Details are important especially for non-project specific equipment eg FAX machine and computers

5 Break out supply costs into major categories (reagents disposables etc) Provide special justification for any unusual expenses requested

6 Detail and justify travel costs Make sure they reflect cuffent fares and lodging costs and that proposed travel is project related

7 Explain any year-to-year fluctuations in the budget including the level of effort of personnel especially if they can not be attributed to routine salary increases Changes should parallel the research plan and project aims

8 Check indirect costs Some institutions have on-campus and off -campus rates

9 Be complete but concise There are no page limits in this section

10 Provide adequate justification for the need to use outside consultants if applicable

11 The budget must be approved by the grantee institution business office before they can sign the application

12 If applicable provide documentation of institutional rates for animal maintenance and acquisition Exceptionally large numbers of animals will need detailed justification

13 Prorate service contracts to percentage of time equipment is used for this project

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ASSURANCES Purpose The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines

Recommended Length A special form must be completed for the assurances section See page B of the PHS 398 application

Content The assurances cover n human subjects n vertebrate animals n inventions and patents n debarment and suspension n drug-free workplace n lobbying n delinquent Federal debt n misconduct in science n civil rights n handicapped individuals n sex discrimination and n age discrimination

Suggestions 1 Be familiar with assurances certifications and requirements for complying with these

regulations

2 Begin to obtain assurances early since they tend to require the cooperation of different institutions

3 Check your institutions grants management office for additional requirements Different institutions follow different procedures and timelines

HUMAN SUBJECTS Purpose The purpose of this section describing the involvement of human subjects is to ensure the protection of the rights and welfare of people who participate in research projects

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section If an exemption has been designated in item 4a on the face page enough detail still must be provided to allow the determination of the appropriateness of the exemption If no exemption is claimed there are six points which must be addressed in this section A full description of these points can be found on page 22 of the PHS 398 application package Be thorough in addressing these six areas

All research applications involving human subjects must address the issue of inclusion of women and minorities in the subject population A justification is required if there is limited representation of women and minorities Peer review and NIH program staff will consider this justification in their evaluation of your application Failure to address this issue will impose a bar making any award until all the concems raised by the IRG have been resolved

The assurance of compliance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 4b of the face page as must the IRB approval date

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Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving human subjects requires a current review by your Institutional Review Board (IRB) Be sure to provide the most recent review date for your project

3 You must provide information on the inclusion of women and minorities in the study population

VERTEBRATE ANIMALS Purpose The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section There are five points which must be addressed in this section A full description of these points can be found on page 23 of the PHS 398 application package Be thorough in addressing these five areas Failure to address any of these areas will delay any award until these issues have been resolved

The animal welfare assurance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 5b of the face page as must the IACUC approval date

Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC) Be sure to provide the most recent review date for your project

3 Be sure the number of animals proposed is realistic

4 Justify all animal expenses

RESOURCES AND ENVIRONMENT Purpose The purpose of the resources and environment section is to describe the resources facilities and support available to the researcher

Recommended Length A special form is provided for the resources and environment section

Suggestions 1 Make sure the resources and environment section addresses all requirements of the proposed

research plan

2 Justify any reliance on resources external to the research

3 Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem

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4 Make certain your resources and budget requests are consistent

OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

2 Use basic English and avoid jargon

3 Make sure all acronyms are spelled out when used initially

4 Type single-spaced and stay within the margins

5 Observe the type size and page limitations strictly do not use a small font

6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

9 List all citations (six pages maximum) at the end of the research plan

10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

11 Have an outside reader review the proposal for clarity and consistency

12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

13 Be consistent with terms references and forrn writing style

14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

16 Make sure all the check-box items on page II of the PHS 398 application are completed

17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

DEA Home

created 27sep95 Lorrie Smith revised 02apr98

Page 10 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

3202002httpdeainfoncinihgovextraextdocsgntapphtm

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Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

The following slides were presented at the University of Louisville on September 23 and 24 1999

Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

Slides Table of Contents

l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

Page 1 of 1How to Apply for NIH Funding (slides)

3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

Third Edition amended August 30 2001

The Original How to Write a Research Grant Application

Contents

Strategy for Getting an NIH Grant 2

Writing an Application for a Research Project Grant 3

I Before You Begin 4

II Application Contents 5

III Developing Your Research Plan 6

IV Application Contents Other Than the Research Plan 15

V Writing and Formatting 18

VI Submitting Your Grant Application 20

VII Problems and Concerns Commonly Cited by Reviewers 21

VIII Referral and Assignment of the Application 23

IX Review of Research Project Applications 24

X How Funding Is Decided 27

XI When You Have Not Obtained Funding 29

XII When Your Application Is Approved for Funding 32

Checklists 35

Strategy for Getting an NIH Grant

1 Assess competition in the field

2 Know the level of resources needed to compete

- do an organizational assessment

- look for opportunities to build research with support from various sources

- get a mentor

3 Be willing to change yourself your projects your career

4 Know the opportunities in the field for

- collaboration with a known laboratory or mentor

- carving out a niche

5 Find out which NIH institutes supporting research in your area are seeking applications

- go to our list of program announcements (PA) on the Web and requests for applications (RFA)

- discuss your ideas with Institute program staff See NIAIDs program and staff listing

6 Make sure you and your collaborators are properly trained for the research

7 Closely examine grant applications from successful grantees

8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

9 Have several experienced grantees critique your application

10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

Writing an Application for a Research Project Grant

There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

Eight Basic Questions Reviewers Ask

1 How high are the intellectual quality and merit of the study

2 What is its potential impact

3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

4 Is the hypothesis valid and have you presented evidence supporting it

5 Are the aims logical

6 Are the procedures appropriate adequate and feasible for the research

7 Are the investigators qualified Have they shown competence credentials and experience

8 Are the facilities adequate and the environment conducive to the research

Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

I Before You Begin

Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

Developing the Hypothesis

Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

State your hypothesis in both the specific aims section of the research plan and the abstract

II Application Contents

Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

III Developing Your Research Plan

A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

- Your application should be based on a strong hypothesis

- Be sure your project has a coherent direction

- Keep the sections of the plan well coordinated and clearly related to the central focus

- Emphasize mechanism A good grant application asks questions about biological mechanisms

- Dont be overly ambitious your plan should be based on a feasible timetable

- Specific aims and experiments should relate directly to the hypothesis to be tested

A Specific Aims

Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

B Background and Significance

Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

Identify the next logical stage of research beyond your current application

C Preliminary StudiesProgress Report

By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

D Research Design and Methods

Describe the experimental design and procedures in detail and give a rationale for their use

Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

advantageous to the research you propose to do

More and more applicants are including colored charts graphs and photographs in their applications

Approach

State why you chose your approach or approaches as opposed to others

If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

Consider the limitations of each approach and how it may affect your results and the data generated

Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

Results

Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

Describe your proposed statistical methods for analyzing the data you plan to collect

Define the criteria for evaluating the success or failure of a specific test

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 9: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

budget for each subcontractor or consortium member

Recommended Length Special forms are provided for the budget and justitication Read the instructions carefully If there is a coinvestigator at another institution for whom funds are requested be sure to include their budget

Content The budget and justification should cover the following n personnel n consultants n equipment n supplies n travel and n other expenses eg animal maintenance

Suggestions

1 Be realistic Both padding and deliberately underbudgeting reflect naivete which will be recognized by reviewers

2 Provide brief descriptions of duties for all positions listed in the budget with the percentage of effort requested each year and any anticipated flucations Special skills or accomplishments of a designated person may be included if not discussed elsewhere

3 If possible try to identify specific individuals for each position requested To be named personnel are very often deleted by reviewers

4 Justify all equipment purchases The proposed acquisition of major pieces of equipment is likely to be scrutinized very carefully Details are important especially for non-project specific equipment eg FAX machine and computers

5 Break out supply costs into major categories (reagents disposables etc) Provide special justification for any unusual expenses requested

6 Detail and justify travel costs Make sure they reflect cuffent fares and lodging costs and that proposed travel is project related

7 Explain any year-to-year fluctuations in the budget including the level of effort of personnel especially if they can not be attributed to routine salary increases Changes should parallel the research plan and project aims

8 Check indirect costs Some institutions have on-campus and off -campus rates

9 Be complete but concise There are no page limits in this section

10 Provide adequate justification for the need to use outside consultants if applicable

11 The budget must be approved by the grantee institution business office before they can sign the application

12 If applicable provide documentation of institutional rates for animal maintenance and acquisition Exceptionally large numbers of animals will need detailed justification

13 Prorate service contracts to percentage of time equipment is used for this project

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ASSURANCES Purpose The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines

Recommended Length A special form must be completed for the assurances section See page B of the PHS 398 application

Content The assurances cover n human subjects n vertebrate animals n inventions and patents n debarment and suspension n drug-free workplace n lobbying n delinquent Federal debt n misconduct in science n civil rights n handicapped individuals n sex discrimination and n age discrimination

Suggestions 1 Be familiar with assurances certifications and requirements for complying with these

regulations

2 Begin to obtain assurances early since they tend to require the cooperation of different institutions

3 Check your institutions grants management office for additional requirements Different institutions follow different procedures and timelines

HUMAN SUBJECTS Purpose The purpose of this section describing the involvement of human subjects is to ensure the protection of the rights and welfare of people who participate in research projects

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section If an exemption has been designated in item 4a on the face page enough detail still must be provided to allow the determination of the appropriateness of the exemption If no exemption is claimed there are six points which must be addressed in this section A full description of these points can be found on page 22 of the PHS 398 application package Be thorough in addressing these six areas

All research applications involving human subjects must address the issue of inclusion of women and minorities in the subject population A justification is required if there is limited representation of women and minorities Peer review and NIH program staff will consider this justification in their evaluation of your application Failure to address this issue will impose a bar making any award until all the concems raised by the IRG have been resolved

The assurance of compliance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 4b of the face page as must the IRB approval date

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Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving human subjects requires a current review by your Institutional Review Board (IRB) Be sure to provide the most recent review date for your project

3 You must provide information on the inclusion of women and minorities in the study population

VERTEBRATE ANIMALS Purpose The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section There are five points which must be addressed in this section A full description of these points can be found on page 23 of the PHS 398 application package Be thorough in addressing these five areas Failure to address any of these areas will delay any award until these issues have been resolved

The animal welfare assurance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 5b of the face page as must the IACUC approval date

Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC) Be sure to provide the most recent review date for your project

3 Be sure the number of animals proposed is realistic

4 Justify all animal expenses

RESOURCES AND ENVIRONMENT Purpose The purpose of the resources and environment section is to describe the resources facilities and support available to the researcher

Recommended Length A special form is provided for the resources and environment section

Suggestions 1 Make sure the resources and environment section addresses all requirements of the proposed

research plan

2 Justify any reliance on resources external to the research

3 Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem

Page 9 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

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4 Make certain your resources and budget requests are consistent

OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

2 Use basic English and avoid jargon

3 Make sure all acronyms are spelled out when used initially

4 Type single-spaced and stay within the margins

5 Observe the type size and page limitations strictly do not use a small font

6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

9 List all citations (six pages maximum) at the end of the research plan

10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

11 Have an outside reader review the proposal for clarity and consistency

12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

13 Be consistent with terms references and forrn writing style

14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

16 Make sure all the check-box items on page II of the PHS 398 application are completed

17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

DEA Home

created 27sep95 Lorrie Smith revised 02apr98

Page 10 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

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Home | Search | Sitemap | Contact

About NICHD | News amp Events | Health Information amp Media | Funding by NICHD | Intramural Research Epidemiology Statistics amp Prevention | Employment amp Fellowships | Research Resources

Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

The following slides were presented at the University of Louisville on September 23 and 24 1999

Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

Slides Table of Contents

l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

Page 1 of 1How to Apply for NIH Funding (slides)

3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

Third Edition amended August 30 2001

The Original How to Write a Research Grant Application

Contents

Strategy for Getting an NIH Grant 2

Writing an Application for a Research Project Grant 3

I Before You Begin 4

II Application Contents 5

III Developing Your Research Plan 6

IV Application Contents Other Than the Research Plan 15

V Writing and Formatting 18

VI Submitting Your Grant Application 20

VII Problems and Concerns Commonly Cited by Reviewers 21

VIII Referral and Assignment of the Application 23

IX Review of Research Project Applications 24

X How Funding Is Decided 27

XI When You Have Not Obtained Funding 29

XII When Your Application Is Approved for Funding 32

Checklists 35

Strategy for Getting an NIH Grant

1 Assess competition in the field

2 Know the level of resources needed to compete

- do an organizational assessment

- look for opportunities to build research with support from various sources

- get a mentor

3 Be willing to change yourself your projects your career

4 Know the opportunities in the field for

- collaboration with a known laboratory or mentor

- carving out a niche

5 Find out which NIH institutes supporting research in your area are seeking applications

- go to our list of program announcements (PA) on the Web and requests for applications (RFA)

- discuss your ideas with Institute program staff See NIAIDs program and staff listing

6 Make sure you and your collaborators are properly trained for the research

7 Closely examine grant applications from successful grantees

8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

9 Have several experienced grantees critique your application

10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

Writing an Application for a Research Project Grant

There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

Eight Basic Questions Reviewers Ask

1 How high are the intellectual quality and merit of the study

2 What is its potential impact

3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

4 Is the hypothesis valid and have you presented evidence supporting it

5 Are the aims logical

6 Are the procedures appropriate adequate and feasible for the research

7 Are the investigators qualified Have they shown competence credentials and experience

8 Are the facilities adequate and the environment conducive to the research

Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

I Before You Begin

Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

Developing the Hypothesis

Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

State your hypothesis in both the specific aims section of the research plan and the abstract

II Application Contents

Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

III Developing Your Research Plan

A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

- Your application should be based on a strong hypothesis

- Be sure your project has a coherent direction

- Keep the sections of the plan well coordinated and clearly related to the central focus

- Emphasize mechanism A good grant application asks questions about biological mechanisms

- Dont be overly ambitious your plan should be based on a feasible timetable

- Specific aims and experiments should relate directly to the hypothesis to be tested

A Specific Aims

Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

B Background and Significance

Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

Identify the next logical stage of research beyond your current application

C Preliminary StudiesProgress Report

By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

D Research Design and Methods

Describe the experimental design and procedures in detail and give a rationale for their use

Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

advantageous to the research you propose to do

More and more applicants are including colored charts graphs and photographs in their applications

Approach

State why you chose your approach or approaches as opposed to others

If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

Consider the limitations of each approach and how it may affect your results and the data generated

Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

Results

Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

Describe your proposed statistical methods for analyzing the data you plan to collect

Define the criteria for evaluating the success or failure of a specific test

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 10: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

ASSURANCES Purpose The purpose of the assurances section is to ensure that the applicant organization will comply with all relevant Federal laws and guidelines

Recommended Length A special form must be completed for the assurances section See page B of the PHS 398 application

Content The assurances cover n human subjects n vertebrate animals n inventions and patents n debarment and suspension n drug-free workplace n lobbying n delinquent Federal debt n misconduct in science n civil rights n handicapped individuals n sex discrimination and n age discrimination

Suggestions 1 Be familiar with assurances certifications and requirements for complying with these

regulations

2 Begin to obtain assurances early since they tend to require the cooperation of different institutions

3 Check your institutions grants management office for additional requirements Different institutions follow different procedures and timelines

HUMAN SUBJECTS Purpose The purpose of this section describing the involvement of human subjects is to ensure the protection of the rights and welfare of people who participate in research projects

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section If an exemption has been designated in item 4a on the face page enough detail still must be provided to allow the determination of the appropriateness of the exemption If no exemption is claimed there are six points which must be addressed in this section A full description of these points can be found on page 22 of the PHS 398 application package Be thorough in addressing these six areas

All research applications involving human subjects must address the issue of inclusion of women and minorities in the subject population A justification is required if there is limited representation of women and minorities Peer review and NIH program staff will consider this justification in their evaluation of your application Failure to address this issue will impose a bar making any award until all the concems raised by the IRG have been resolved

The assurance of compliance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 4b of the face page as must the IRB approval date

Page 8 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

3202002httpdeainfoncinihgovextraextdocsgntapphtm

Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving human subjects requires a current review by your Institutional Review Board (IRB) Be sure to provide the most recent review date for your project

3 You must provide information on the inclusion of women and minorities in the study population

VERTEBRATE ANIMALS Purpose The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section There are five points which must be addressed in this section A full description of these points can be found on page 23 of the PHS 398 application package Be thorough in addressing these five areas Failure to address any of these areas will delay any award until these issues have been resolved

The animal welfare assurance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 5b of the face page as must the IACUC approval date

Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC) Be sure to provide the most recent review date for your project

3 Be sure the number of animals proposed is realistic

4 Justify all animal expenses

RESOURCES AND ENVIRONMENT Purpose The purpose of the resources and environment section is to describe the resources facilities and support available to the researcher

Recommended Length A special form is provided for the resources and environment section

Suggestions 1 Make sure the resources and environment section addresses all requirements of the proposed

research plan

2 Justify any reliance on resources external to the research

3 Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem

Page 9 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

3202002httpdeainfoncinihgovextraextdocsgntapphtm

4 Make certain your resources and budget requests are consistent

OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

2 Use basic English and avoid jargon

3 Make sure all acronyms are spelled out when used initially

4 Type single-spaced and stay within the margins

5 Observe the type size and page limitations strictly do not use a small font

6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

9 List all citations (six pages maximum) at the end of the research plan

10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

11 Have an outside reader review the proposal for clarity and consistency

12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

13 Be consistent with terms references and forrn writing style

14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

16 Make sure all the check-box items on page II of the PHS 398 application are completed

17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

DEA Home

created 27sep95 Lorrie Smith revised 02apr98

Page 10 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

3202002httpdeainfoncinihgovextraextdocsgntapphtm

Home | Search | Sitemap | Contact

About NICHD | News amp Events | Health Information amp Media | Funding by NICHD | Intramural Research Epidemiology Statistics amp Prevention | Employment amp Fellowships | Research Resources

Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

The following slides were presented at the University of Louisville on September 23 and 24 1999

Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

Slides Table of Contents

l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

Page 1 of 1How to Apply for NIH Funding (slides)

3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

Third Edition amended August 30 2001

The Original How to Write a Research Grant Application

Contents

Strategy for Getting an NIH Grant 2

Writing an Application for a Research Project Grant 3

I Before You Begin 4

II Application Contents 5

III Developing Your Research Plan 6

IV Application Contents Other Than the Research Plan 15

V Writing and Formatting 18

VI Submitting Your Grant Application 20

VII Problems and Concerns Commonly Cited by Reviewers 21

VIII Referral and Assignment of the Application 23

IX Review of Research Project Applications 24

X How Funding Is Decided 27

XI When You Have Not Obtained Funding 29

XII When Your Application Is Approved for Funding 32

Checklists 35

Strategy for Getting an NIH Grant

1 Assess competition in the field

2 Know the level of resources needed to compete

- do an organizational assessment

- look for opportunities to build research with support from various sources

- get a mentor

3 Be willing to change yourself your projects your career

4 Know the opportunities in the field for

- collaboration with a known laboratory or mentor

- carving out a niche

5 Find out which NIH institutes supporting research in your area are seeking applications

- go to our list of program announcements (PA) on the Web and requests for applications (RFA)

- discuss your ideas with Institute program staff See NIAIDs program and staff listing

6 Make sure you and your collaborators are properly trained for the research

7 Closely examine grant applications from successful grantees

8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

9 Have several experienced grantees critique your application

10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

Writing an Application for a Research Project Grant

There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

Eight Basic Questions Reviewers Ask

1 How high are the intellectual quality and merit of the study

2 What is its potential impact

3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

4 Is the hypothesis valid and have you presented evidence supporting it

5 Are the aims logical

6 Are the procedures appropriate adequate and feasible for the research

7 Are the investigators qualified Have they shown competence credentials and experience

8 Are the facilities adequate and the environment conducive to the research

Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

I Before You Begin

Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

Developing the Hypothesis

Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

State your hypothesis in both the specific aims section of the research plan and the abstract

II Application Contents

Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

III Developing Your Research Plan

A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

- Your application should be based on a strong hypothesis

- Be sure your project has a coherent direction

- Keep the sections of the plan well coordinated and clearly related to the central focus

- Emphasize mechanism A good grant application asks questions about biological mechanisms

- Dont be overly ambitious your plan should be based on a feasible timetable

- Specific aims and experiments should relate directly to the hypothesis to be tested

A Specific Aims

Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

B Background and Significance

Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

Identify the next logical stage of research beyond your current application

C Preliminary StudiesProgress Report

By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

D Research Design and Methods

Describe the experimental design and procedures in detail and give a rationale for their use

Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

advantageous to the research you propose to do

More and more applicants are including colored charts graphs and photographs in their applications

Approach

State why you chose your approach or approaches as opposed to others

If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

Consider the limitations of each approach and how it may affect your results and the data generated

Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

Results

Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

Describe your proposed statistical methods for analyzing the data you plan to collect

Define the criteria for evaluating the success or failure of a specific test

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 11: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving human subjects requires a current review by your Institutional Review Board (IRB) Be sure to provide the most recent review date for your project

3 You must provide information on the inclusion of women and minorities in the study population

VERTEBRATE ANIMALS Purpose The purpose of this section describing the use of vertebrate animals is to ensure the humane treatment of live animals involved in the proposed research

Recommended Length There is no specified length but be succinct

Content Provide a complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section There are five points which must be addressed in this section A full description of these points can be found on page 23 of the PHS 398 application package Be thorough in addressing these five areas Failure to address any of these areas will delay any award until these issues have been resolved

The animal welfare assurance number from the NIH Office of Protection from Research Risks (OPRR) must be provided in item 5b of the face page as must the IACUC approval date

Suggestions 1 Most institutions have a multiple project assurance from OPRR If your institution does not

contact OPRR as soon as possible to obtain a single project assurance

2 All research involving vertebrate animals requires a review by your Institutional Animal Care and Use Committee (IACUC) Be sure to provide the most recent review date for your project

3 Be sure the number of animals proposed is realistic

4 Justify all animal expenses

RESOURCES AND ENVIRONMENT Purpose The purpose of the resources and environment section is to describe the resources facilities and support available to the researcher

Recommended Length A special form is provided for the resources and environment section

Suggestions 1 Make sure the resources and environment section addresses all requirements of the proposed

research plan

2 Justify any reliance on resources external to the research

3 Make sure all subcontractors and consortium members have the capability to perform the tasks assigned to tfiem

Page 9 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

3202002httpdeainfoncinihgovextraextdocsgntapphtm

4 Make certain your resources and budget requests are consistent

OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

2 Use basic English and avoid jargon

3 Make sure all acronyms are spelled out when used initially

4 Type single-spaced and stay within the margins

5 Observe the type size and page limitations strictly do not use a small font

6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

9 List all citations (six pages maximum) at the end of the research plan

10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

11 Have an outside reader review the proposal for clarity and consistency

12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

13 Be consistent with terms references and forrn writing style

14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

16 Make sure all the check-box items on page II of the PHS 398 application are completed

17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

DEA Home

created 27sep95 Lorrie Smith revised 02apr98

Page 10 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

3202002httpdeainfoncinihgovextraextdocsgntapphtm

Home | Search | Sitemap | Contact

About NICHD | News amp Events | Health Information amp Media | Funding by NICHD | Intramural Research Epidemiology Statistics amp Prevention | Employment amp Fellowships | Research Resources

Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

The following slides were presented at the University of Louisville on September 23 and 24 1999

Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

Slides Table of Contents

l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

Page 1 of 1How to Apply for NIH Funding (slides)

3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

Third Edition amended August 30 2001

The Original How to Write a Research Grant Application

Contents

Strategy for Getting an NIH Grant 2

Writing an Application for a Research Project Grant 3

I Before You Begin 4

II Application Contents 5

III Developing Your Research Plan 6

IV Application Contents Other Than the Research Plan 15

V Writing and Formatting 18

VI Submitting Your Grant Application 20

VII Problems and Concerns Commonly Cited by Reviewers 21

VIII Referral and Assignment of the Application 23

IX Review of Research Project Applications 24

X How Funding Is Decided 27

XI When You Have Not Obtained Funding 29

XII When Your Application Is Approved for Funding 32

Checklists 35

Strategy for Getting an NIH Grant

1 Assess competition in the field

2 Know the level of resources needed to compete

- do an organizational assessment

- look for opportunities to build research with support from various sources

- get a mentor

3 Be willing to change yourself your projects your career

4 Know the opportunities in the field for

- collaboration with a known laboratory or mentor

- carving out a niche

5 Find out which NIH institutes supporting research in your area are seeking applications

- go to our list of program announcements (PA) on the Web and requests for applications (RFA)

- discuss your ideas with Institute program staff See NIAIDs program and staff listing

6 Make sure you and your collaborators are properly trained for the research

7 Closely examine grant applications from successful grantees

8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

9 Have several experienced grantees critique your application

10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

Writing an Application for a Research Project Grant

There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

Eight Basic Questions Reviewers Ask

1 How high are the intellectual quality and merit of the study

2 What is its potential impact

3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

4 Is the hypothesis valid and have you presented evidence supporting it

5 Are the aims logical

6 Are the procedures appropriate adequate and feasible for the research

7 Are the investigators qualified Have they shown competence credentials and experience

8 Are the facilities adequate and the environment conducive to the research

Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

I Before You Begin

Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

Developing the Hypothesis

Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

State your hypothesis in both the specific aims section of the research plan and the abstract

II Application Contents

Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

III Developing Your Research Plan

A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

- Your application should be based on a strong hypothesis

- Be sure your project has a coherent direction

- Keep the sections of the plan well coordinated and clearly related to the central focus

- Emphasize mechanism A good grant application asks questions about biological mechanisms

- Dont be overly ambitious your plan should be based on a feasible timetable

- Specific aims and experiments should relate directly to the hypothesis to be tested

A Specific Aims

Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

B Background and Significance

Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

Identify the next logical stage of research beyond your current application

C Preliminary StudiesProgress Report

By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

D Research Design and Methods

Describe the experimental design and procedures in detail and give a rationale for their use

Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

advantageous to the research you propose to do

More and more applicants are including colored charts graphs and photographs in their applications

Approach

State why you chose your approach or approaches as opposed to others

If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

Consider the limitations of each approach and how it may affect your results and the data generated

Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

Results

Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

Describe your proposed statistical methods for analyzing the data you plan to collect

Define the criteria for evaluating the success or failure of a specific test

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 12: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

4 Make certain your resources and budget requests are consistent

OVERALL CONSIDERATIONS 1 Observe application guidelines strictly

2 Use basic English and avoid jargon

3 Make sure all acronyms are spelled out when used initially

4 Type single-spaced and stay within the margins

5 Observe the type size and page limitations strictly do not use a small font

6 Do not use photo reductions on a copy machine particularly gels etc because they may become unreadable

7 Draw or print all graphs diagrams charts and tables in black ink (be consistent with formats) Label these items carefully

8 Include only those graphs tables etc that are essential to the narrative these should complement the text and be appropriately inserted

9 List all citations (six pages maximum) at the end of the research plan

10 Make sure all citations are complete title authors book or jounal volume number inclusive pages year of publication

11 Have an outside reader review the proposal for clarity and consistency

12 Proofread carefully by reading aloud Do not rely on computer spell check to point out mistakes

13 Be consistent with terms references and forrn writing style

14 Supplement the text material by including additional information in the appendices However appendices should contain supportive or supplemental rather than essential material Essential data should be included within the body of the application Provide a table of contents of the appendices for easy reference by the reviewers

15 Make sure the application is signed and dated by you (the Principal Investigator) and by the designated institutional business official

16 Make sure all the check-box items on page II of the PHS 398 application are completed

17 Be sure that your application is received at the Division of Research Grants by the appropriate deadline

DEA Home

created 27sep95 Lorrie Smith revised 02apr98

Page 10 of 10NCIDEA A short Guide to the Preparation of NIH Grant Applications

3202002httpdeainfoncinihgovextraextdocsgntapphtm

Home | Search | Sitemap | Contact

About NICHD | News amp Events | Health Information amp Media | Funding by NICHD | Intramural Research Epidemiology Statistics amp Prevention | Employment amp Fellowships | Research Resources

Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

The following slides were presented at the University of Louisville on September 23 and 24 1999

Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

Slides Table of Contents

l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

Page 1 of 1How to Apply for NIH Funding (slides)

3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

Third Edition amended August 30 2001

The Original How to Write a Research Grant Application

Contents

Strategy for Getting an NIH Grant 2

Writing an Application for a Research Project Grant 3

I Before You Begin 4

II Application Contents 5

III Developing Your Research Plan 6

IV Application Contents Other Than the Research Plan 15

V Writing and Formatting 18

VI Submitting Your Grant Application 20

VII Problems and Concerns Commonly Cited by Reviewers 21

VIII Referral and Assignment of the Application 23

IX Review of Research Project Applications 24

X How Funding Is Decided 27

XI When You Have Not Obtained Funding 29

XII When Your Application Is Approved for Funding 32

Checklists 35

Strategy for Getting an NIH Grant

1 Assess competition in the field

2 Know the level of resources needed to compete

- do an organizational assessment

- look for opportunities to build research with support from various sources

- get a mentor

3 Be willing to change yourself your projects your career

4 Know the opportunities in the field for

- collaboration with a known laboratory or mentor

- carving out a niche

5 Find out which NIH institutes supporting research in your area are seeking applications

- go to our list of program announcements (PA) on the Web and requests for applications (RFA)

- discuss your ideas with Institute program staff See NIAIDs program and staff listing

6 Make sure you and your collaborators are properly trained for the research

7 Closely examine grant applications from successful grantees

8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

9 Have several experienced grantees critique your application

10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

Writing an Application for a Research Project Grant

There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

Eight Basic Questions Reviewers Ask

1 How high are the intellectual quality and merit of the study

2 What is its potential impact

3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

4 Is the hypothesis valid and have you presented evidence supporting it

5 Are the aims logical

6 Are the procedures appropriate adequate and feasible for the research

7 Are the investigators qualified Have they shown competence credentials and experience

8 Are the facilities adequate and the environment conducive to the research

Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

I Before You Begin

Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

Developing the Hypothesis

Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

State your hypothesis in both the specific aims section of the research plan and the abstract

II Application Contents

Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

III Developing Your Research Plan

A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

- Your application should be based on a strong hypothesis

- Be sure your project has a coherent direction

- Keep the sections of the plan well coordinated and clearly related to the central focus

- Emphasize mechanism A good grant application asks questions about biological mechanisms

- Dont be overly ambitious your plan should be based on a feasible timetable

- Specific aims and experiments should relate directly to the hypothesis to be tested

A Specific Aims

Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

B Background and Significance

Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

Identify the next logical stage of research beyond your current application

C Preliminary StudiesProgress Report

By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

D Research Design and Methods

Describe the experimental design and procedures in detail and give a rationale for their use

Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

advantageous to the research you propose to do

More and more applicants are including colored charts graphs and photographs in their applications

Approach

State why you chose your approach or approaches as opposed to others

If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

Consider the limitations of each approach and how it may affect your results and the data generated

Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

Results

Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

Describe your proposed statistical methods for analyzing the data you plan to collect

Define the criteria for evaluating the success or failure of a specific test

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 13: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

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Funding by NICHD - Applying for Funding How to Apply for NIH Funding (slides)

The following slides were presented at the University of Louisville on September 23 and 24 1999

Begin the slide show or Download the original slideshow (created with Microsoft PowerPoint 97)

Slides Table of Contents

l How to Apply for NIH Funding l AdministrativeTechnical Issues l The Application Form l Hypothesis l The Application Parts l Abstract l Background and Significance l Specific Aims l Preliminary Data l Research Plan l Research Plan Continued l Special Issues l Logistics

NICHD Home | NIH Home | NICHD Disclaimer | Accessibility | Top of Page Last Modified 06192001 110442

Page 1 of 1How to Apply for NIH Funding (slides)

3202002httpwwwnichdnihgovfundingapply_nihapply_nihhtm

Third Edition amended August 30 2001

The Original How to Write a Research Grant Application

Contents

Strategy for Getting an NIH Grant 2

Writing an Application for a Research Project Grant 3

I Before You Begin 4

II Application Contents 5

III Developing Your Research Plan 6

IV Application Contents Other Than the Research Plan 15

V Writing and Formatting 18

VI Submitting Your Grant Application 20

VII Problems and Concerns Commonly Cited by Reviewers 21

VIII Referral and Assignment of the Application 23

IX Review of Research Project Applications 24

X How Funding Is Decided 27

XI When You Have Not Obtained Funding 29

XII When Your Application Is Approved for Funding 32

Checklists 35

Strategy for Getting an NIH Grant

1 Assess competition in the field

2 Know the level of resources needed to compete

- do an organizational assessment

- look for opportunities to build research with support from various sources

- get a mentor

3 Be willing to change yourself your projects your career

4 Know the opportunities in the field for

- collaboration with a known laboratory or mentor

- carving out a niche

5 Find out which NIH institutes supporting research in your area are seeking applications

- go to our list of program announcements (PA) on the Web and requests for applications (RFA)

- discuss your ideas with Institute program staff See NIAIDs program and staff listing

6 Make sure you and your collaborators are properly trained for the research

7 Closely examine grant applications from successful grantees

8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

9 Have several experienced grantees critique your application

10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

Writing an Application for a Research Project Grant

There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

Eight Basic Questions Reviewers Ask

1 How high are the intellectual quality and merit of the study

2 What is its potential impact

3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

4 Is the hypothesis valid and have you presented evidence supporting it

5 Are the aims logical

6 Are the procedures appropriate adequate and feasible for the research

7 Are the investigators qualified Have they shown competence credentials and experience

8 Are the facilities adequate and the environment conducive to the research

Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

I Before You Begin

Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

Developing the Hypothesis

Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

State your hypothesis in both the specific aims section of the research plan and the abstract

II Application Contents

Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

III Developing Your Research Plan

A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

- Your application should be based on a strong hypothesis

- Be sure your project has a coherent direction

- Keep the sections of the plan well coordinated and clearly related to the central focus

- Emphasize mechanism A good grant application asks questions about biological mechanisms

- Dont be overly ambitious your plan should be based on a feasible timetable

- Specific aims and experiments should relate directly to the hypothesis to be tested

A Specific Aims

Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

B Background and Significance

Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

Identify the next logical stage of research beyond your current application

C Preliminary StudiesProgress Report

By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

D Research Design and Methods

Describe the experimental design and procedures in detail and give a rationale for their use

Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

advantageous to the research you propose to do

More and more applicants are including colored charts graphs and photographs in their applications

Approach

State why you chose your approach or approaches as opposed to others

If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

Consider the limitations of each approach and how it may affect your results and the data generated

Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

Results

Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

Describe your proposed statistical methods for analyzing the data you plan to collect

Define the criteria for evaluating the success or failure of a specific test

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 14: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

Third Edition amended August 30 2001

The Original How to Write a Research Grant Application

Contents

Strategy for Getting an NIH Grant 2

Writing an Application for a Research Project Grant 3

I Before You Begin 4

II Application Contents 5

III Developing Your Research Plan 6

IV Application Contents Other Than the Research Plan 15

V Writing and Formatting 18

VI Submitting Your Grant Application 20

VII Problems and Concerns Commonly Cited by Reviewers 21

VIII Referral and Assignment of the Application 23

IX Review of Research Project Applications 24

X How Funding Is Decided 27

XI When You Have Not Obtained Funding 29

XII When Your Application Is Approved for Funding 32

Checklists 35

Strategy for Getting an NIH Grant

1 Assess competition in the field

2 Know the level of resources needed to compete

- do an organizational assessment

- look for opportunities to build research with support from various sources

- get a mentor

3 Be willing to change yourself your projects your career

4 Know the opportunities in the field for

- collaboration with a known laboratory or mentor

- carving out a niche

5 Find out which NIH institutes supporting research in your area are seeking applications

- go to our list of program announcements (PA) on the Web and requests for applications (RFA)

- discuss your ideas with Institute program staff See NIAIDs program and staff listing

6 Make sure you and your collaborators are properly trained for the research

7 Closely examine grant applications from successful grantees

8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

9 Have several experienced grantees critique your application

10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

Writing an Application for a Research Project Grant

There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

Eight Basic Questions Reviewers Ask

1 How high are the intellectual quality and merit of the study

2 What is its potential impact

3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

4 Is the hypothesis valid and have you presented evidence supporting it

5 Are the aims logical

6 Are the procedures appropriate adequate and feasible for the research

7 Are the investigators qualified Have they shown competence credentials and experience

8 Are the facilities adequate and the environment conducive to the research

Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

I Before You Begin

Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

Developing the Hypothesis

Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

State your hypothesis in both the specific aims section of the research plan and the abstract

II Application Contents

Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

III Developing Your Research Plan

A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

- Your application should be based on a strong hypothesis

- Be sure your project has a coherent direction

- Keep the sections of the plan well coordinated and clearly related to the central focus

- Emphasize mechanism A good grant application asks questions about biological mechanisms

- Dont be overly ambitious your plan should be based on a feasible timetable

- Specific aims and experiments should relate directly to the hypothesis to be tested

A Specific Aims

Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

B Background and Significance

Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

Identify the next logical stage of research beyond your current application

C Preliminary StudiesProgress Report

By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

D Research Design and Methods

Describe the experimental design and procedures in detail and give a rationale for their use

Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

advantageous to the research you propose to do

More and more applicants are including colored charts graphs and photographs in their applications

Approach

State why you chose your approach or approaches as opposed to others

If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

Consider the limitations of each approach and how it may affect your results and the data generated

Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

Results

Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

Describe your proposed statistical methods for analyzing the data you plan to collect

Define the criteria for evaluating the success or failure of a specific test

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 15: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

Strategy for Getting an NIH Grant

1 Assess competition in the field

2 Know the level of resources needed to compete

- do an organizational assessment

- look for opportunities to build research with support from various sources

- get a mentor

3 Be willing to change yourself your projects your career

4 Know the opportunities in the field for

- collaboration with a known laboratory or mentor

- carving out a niche

5 Find out which NIH institutes supporting research in your area are seeking applications

- go to our list of program announcements (PA) on the Web and requests for applications (RFA)

- discuss your ideas with Institute program staff See NIAIDs program and staff listing

6 Make sure you and your collaborators are properly trained for the research

7 Closely examine grant applications from successful grantees

8 Read the instructions in the grant application kit (PHS 398) then read them again Follow them to the letter

9 Have several experienced grantees critique your application

10 Consider requesting NIH to refer your application to a study section that has a high level of interest and expertise in your research topic

Writing an Application for a Research Project Grant

There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

Eight Basic Questions Reviewers Ask

1 How high are the intellectual quality and merit of the study

2 What is its potential impact

3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

4 Is the hypothesis valid and have you presented evidence supporting it

5 Are the aims logical

6 Are the procedures appropriate adequate and feasible for the research

7 Are the investigators qualified Have they shown competence credentials and experience

8 Are the facilities adequate and the environment conducive to the research

Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

I Before You Begin

Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

Developing the Hypothesis

Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

State your hypothesis in both the specific aims section of the research plan and the abstract

II Application Contents

Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

III Developing Your Research Plan

A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

- Your application should be based on a strong hypothesis

- Be sure your project has a coherent direction

- Keep the sections of the plan well coordinated and clearly related to the central focus

- Emphasize mechanism A good grant application asks questions about biological mechanisms

- Dont be overly ambitious your plan should be based on a feasible timetable

- Specific aims and experiments should relate directly to the hypothesis to be tested

A Specific Aims

Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

B Background and Significance

Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

Identify the next logical stage of research beyond your current application

C Preliminary StudiesProgress Report

By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

D Research Design and Methods

Describe the experimental design and procedures in detail and give a rationale for their use

Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

advantageous to the research you propose to do

More and more applicants are including colored charts graphs and photographs in their applications

Approach

State why you chose your approach or approaches as opposed to others

If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

Consider the limitations of each approach and how it may affect your results and the data generated

Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

Results

Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

Describe your proposed statistical methods for analyzing the data you plan to collect

Define the criteria for evaluating the success or failure of a specific test

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 16: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

Writing an Application for a Research Project Grant

There are several components to a strong grant application First the subject must be creative exciting and worthy of funding Then the project must be developed through a rigorous well defined experimental plan Finally you must make sure that the information is presented in clear language and that your application follows the rules and guidelines detailed in the grant application kit PHS 398

This document will help you make sure your application for a research project grant (R01) addresses the key questions reviewers ask

Eight Basic Questions Reviewers Ask

1 How high are the intellectual quality and merit of the study

2 What is its potential impact

3 How novel is the proposal If not novel to what extent does potential impact overcome this lack Is the research likely to produce new data and concepts or confirm existing hypotheses

4 Is the hypothesis valid and have you presented evidence supporting it

5 Are the aims logical

6 Are the procedures appropriate adequate and feasible for the research

7 Are the investigators qualified Have they shown competence credentials and experience

8 Are the facilities adequate and the environment conducive to the research

Writing a grant application is a major undertaking Below is advice from experienced NIH staff to help you succeed Please note that this document does not repeat instructions in the PHS 398 application kit

A note on mechanism Though the advice we provide is relevant for all research grants it is geared toward the research project (R01) For additional advice on other mechanisms contact an NIH program administrator (see our listing of NIAID programs and staff) or NIAIDs Scientific Review Program at 301496-2550

Further when applying for a grant in response to a request for applications or a program announcement carefully read the review criteria and any special instructions before preparing the application

I Before You Begin

Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

Developing the Hypothesis

Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

State your hypothesis in both the specific aims section of the research plan and the abstract

II Application Contents

Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

III Developing Your Research Plan

A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

- Your application should be based on a strong hypothesis

- Be sure your project has a coherent direction

- Keep the sections of the plan well coordinated and clearly related to the central focus

- Emphasize mechanism A good grant application asks questions about biological mechanisms

- Dont be overly ambitious your plan should be based on a feasible timetable

- Specific aims and experiments should relate directly to the hypothesis to be tested

A Specific Aims

Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

B Background and Significance

Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

Identify the next logical stage of research beyond your current application

C Preliminary StudiesProgress Report

By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

D Research Design and Methods

Describe the experimental design and procedures in detail and give a rationale for their use

Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

advantageous to the research you propose to do

More and more applicants are including colored charts graphs and photographs in their applications

Approach

State why you chose your approach or approaches as opposed to others

If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

Consider the limitations of each approach and how it may affect your results and the data generated

Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

Results

Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

Describe your proposed statistical methods for analyzing the data you plan to collect

Define the criteria for evaluating the success or failure of a specific test

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 17: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

I Before You Begin

Before you start writing the application make sure youve done your homework know the field choose an excellent idea to pursue and equally important read the entire grant application kit (PHS 398) very carefully This document does not repeat instructions contained in PHS 398

Begin by focusing on the big picture It is critical that you are intimately familiar with the field in which you are considering applying to NIH for funding You must be aware of the fields directions knowledge gaps and research already being done Your application will be reviewed by your peers investigators who are knowledgeable about the research area of your proposal

To succeed you will have to be at least as knowledgeable as they are Consider the reviewers to be informed strangers You must include enough detail to convince them your hypothesis is sound and important your aims are logical and feasible you understand potential problems and you can properly analyze the data

Developing the Hypothesis

Provide a rationale for the hypothesis Make sure its based on current scientific literature Consider alternative hypotheses Your research plan will explain why you chose the one you selected A good hypothesis should increase understanding of normal biologic processes diseases or treatments or preventions

Your proposal should be driven by one or more hypotheses not by advances in technology (ie it should not be a method in search of a problem) Also avoid proposing a fishing expedition that lacks solid scientific basis

State your hypothesis in both the specific aims section of the research plan and the abstract

II Application Contents

Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

III Developing Your Research Plan

A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

- Your application should be based on a strong hypothesis

- Be sure your project has a coherent direction

- Keep the sections of the plan well coordinated and clearly related to the central focus

- Emphasize mechanism A good grant application asks questions about biological mechanisms

- Dont be overly ambitious your plan should be based on a feasible timetable

- Specific aims and experiments should relate directly to the hypothesis to be tested

A Specific Aims

Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

B Background and Significance

Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

Identify the next logical stage of research beyond your current application

C Preliminary StudiesProgress Report

By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

D Research Design and Methods

Describe the experimental design and procedures in detail and give a rationale for their use

Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

advantageous to the research you propose to do

More and more applicants are including colored charts graphs and photographs in their applications

Approach

State why you chose your approach or approaches as opposed to others

If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

Consider the limitations of each approach and how it may affect your results and the data generated

Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

Results

Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

Describe your proposed statistical methods for analyzing the data you plan to collect

Define the criteria for evaluating the success or failure of a specific test

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 18: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

II Application Contents

Before you start writing carefully read PHS 398 Application for a Public Health Service Grant Please note changes made as a result of modular grants (sections with asterisks below) Go to the NIH modular grants and applications Web page and the notice in the NIH Guide for Grants and Contracts for more information

The PHS 398 grant application kit gives you information and guidance on these sections of the application Face page Description (abstract)Performance sites Key personnelTable of contents Detailed budget for initial budget period Budget for entire proposed period of support Biographical Sketch Other support Resources Research Plan Appendix Checklist Personnel report Personal data

Not needed for modular grants and applications which applies to most types requesting up to $250000 in direct costs

Changed as a result of modular grants see Internet address above and the article in NIAID Council News Whats Different About Modular Grants

Below we outline the sections of the PHS 398 in the order in which you would likely develop them As the biggest and most important part of your application upon which the rest hinges the research plan is a good place to begin

III Developing Your Research Plan

A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

- Your application should be based on a strong hypothesis

- Be sure your project has a coherent direction

- Keep the sections of the plan well coordinated and clearly related to the central focus

- Emphasize mechanism A good grant application asks questions about biological mechanisms

- Dont be overly ambitious your plan should be based on a feasible timetable

- Specific aims and experiments should relate directly to the hypothesis to be tested

A Specific Aims

Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

B Background and Significance

Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

Identify the next logical stage of research beyond your current application

C Preliminary StudiesProgress Report

By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

D Research Design and Methods

Describe the experimental design and procedures in detail and give a rationale for their use

Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

advantageous to the research you propose to do

More and more applicants are including colored charts graphs and photographs in their applications

Approach

State why you chose your approach or approaches as opposed to others

If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

Consider the limitations of each approach and how it may affect your results and the data generated

Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

Results

Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

Describe your proposed statistical methods for analyzing the data you plan to collect

Define the criteria for evaluating the success or failure of a specific test

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 19: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

III Developing Your Research Plan

A top-quality research plan is the most important factor determining your applications success in peer review As with a scientific publication developing your ideas is key Read the PHS 398 grant application kit carefully for specific elements to be included in the research plan Before we go into specific sections of the plan here are some general tips

- Your application should be based on a strong hypothesis

- Be sure your project has a coherent direction

- Keep the sections of the plan well coordinated and clearly related to the central focus

- Emphasize mechanism A good grant application asks questions about biological mechanisms

- Dont be overly ambitious your plan should be based on a feasible timetable

- Specific aims and experiments should relate directly to the hypothesis to be tested

A Specific Aims

Your specific aims are the objectives of your research project what you want to accomplish The project aims should be driven by the hypothesis you set out to test Make sure they are highly focused

Begin this section by stating the general purpose or major objectives of your research Be sure that all objectives relate directly to the hypothesis you are setting out to test If you have more than one hypothesis state specific aims for each one Keep in mind that your research methods will relate directly to the aims you have described

State alternatives to your hypothesis and explain why you chose the one (or more) you selected Choose objectives that can be easily assessed by the review committee Do not confuse specific aims with long-term goals

B Background and Significance

Keep the statement of significance brief State how your research is innovative how your proposal looks at a topic from a fresh point of view or develops or improves technology

Show how the hypothesis and research will increase knowledge Relate them to the longer-term big picture scientific objectives and to the betterment of public health

Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

Identify the next logical stage of research beyond your current application

C Preliminary StudiesProgress Report

By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

D Research Design and Methods

Describe the experimental design and procedures in detail and give a rationale for their use

Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

advantageous to the research you propose to do

More and more applicants are including colored charts graphs and photographs in their applications

Approach

State why you chose your approach or approaches as opposed to others

If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

Consider the limitations of each approach and how it may affect your results and the data generated

Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

Results

Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

Describe your proposed statistical methods for analyzing the data you plan to collect

Define the criteria for evaluating the success or failure of a specific test

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 20: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

Justify your proposal with background information about the research field that led to the research you are proposing The literature section is very important because it shows reviewers that you understand the field and have a balanced and adequate knowledge of it

Use this opportunity to reveal that you are aware of gaps or discrepancies in the field Show familiarity with unpublished work gained through personal contacts as well

Identify the next logical stage of research beyond your current application

C Preliminary StudiesProgress Report

By providing preliminary data this extremely important section helps build reviewers confidence that you can handle the technologies understand the methods and interpret results

Preliminary data should support the hypothesis to be tested and the feasibility of the project Explain how the preliminary results are valid and how early studies will be expanded in scope or size

Make sure you interpret results critically Showing alternative meanings indicates that youve thought the problem through and will be able to meet future challenges

Preliminary data may consist of your own publications publications of others unpublished data from your own laboratory or from others or some combination of these

Include manuscripts submitted for publication Make sure itrsquos clear which data are yours and which were reported by others

D Research Design and Methods

Describe the experimental design and procedures in detail and give a rationale for their use

Organize this section so each experiment or set of experiments corresponds to one of your specific aims and is stated in the same order Even holding to this structure the experiments still must follow a logical sequence They must have a clear direction or priority ie the experiments should follow from one another and have a clear starting or finishing point

Convince reviewers that the methods you chose are appropriate to your specific aims that you are familiar with them and that unless innovative they are well established If your methods are innovative show how you have changed existing proven methods while avoiding technical problems Also describe why the new methods are

advantageous to the research you propose to do

More and more applicants are including colored charts graphs and photographs in their applications

Approach

State why you chose your approach or approaches as opposed to others

If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

Consider the limitations of each approach and how it may affect your results and the data generated

Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

Results

Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

Describe your proposed statistical methods for analyzing the data you plan to collect

Define the criteria for evaluating the success or failure of a specific test

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 21: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

advantageous to the research you propose to do

More and more applicants are including colored charts graphs and photographs in their applications

Approach

State why you chose your approach or approaches as opposed to others

If you are choosing a nonstandard approach explain why it is more advantageous than a conventional one Ask yourself whether the innovative procedures are feasible and within your competence

Call attention to potential difficulties you may encounter with each approach Reviewers will be aware of possible problems convince them you can handle such circumstances Propose alternatives that would circumvent potential limitations

Consider the limitations of each approach and how it may affect your results and the data generated

Spell it out in detail While you may assume reviewers are experts in the field and familiar with current methodology they will not make the same assumption about you It is not sufficient to state We will grow a variety of viruses in cells using standard in vitro tissue culture techniques Reviewers want to know which viruses cells and techniques the rationale for using the particular system and exactly how the techniques will be used Details show you understand and can handle the research

Make sure any proposed model systems are appropriate to address the research questions and are highly relevant to the medical problem being modeled

Results

Show that you are aware of the limits too and value of the kinds of results you can expect based on current knowledge of the subject State the conditions under which the data would support or contradict the hypothesis and the limits you will observe in interpreting the results

Show reviewers you will be able to interpret your results by revealing your understanding of the complexities of the subject

Many applications benefit from statistical analysis The early involvement of a statistician to determine the amount of data to collect and the methods for analyses will favorably impress reviewers

Describe your proposed statistical methods for analyzing the data you plan to collect

Define the criteria for evaluating the success or failure of a specific test

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 22: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

Other pointers

Read the PHS 398 carefully for specific requirements especially those involving human subjects

Estimate how much you expect to accomplish each year of the grant and state any potential delays you can anticipate

Describe sources of reagents animals or equipment not generally available If collaborators will provide them include letters from the sources in your application

Describe any procedures situations or materials that may be hazardous and precautions you will take

Include supporting data Where appropriate include well-designed tables and figures Use titles that are accurate and informative Label the axes and include legends Reviewers will look for discrepancies between your data and text

E Human Subjects

Is it human subject research

Even if you are not seeing patients your research may fall under the rubric of human subjects which includes studying samples from identifiable people See the review decision trees to determine whether your research involves human subjects and what is needed if it does

A human subject is defined as a living person with whom an investigator directly interacts or intervenes or obtains identifiable private information Regulations apply to human organs tissues body fluids and recorded information from identifiable people Go to our glossary for more human subjects definitions

If you are not conducting human subject research indicate ldquoNot applicablerdquo in this section of the research plan

If the answer is yes

If your project does use human subjects or samples read the human subjects section of the 398 carefully and follow all instructions to the letter

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 23: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

This section of your research plan should include enough information so reviewers have no questions about what you propose to do Also clearly show how you will include diverse populations and protect subjects from study-associated risks

The May 2001 PHS 398 expands reporting and inclusion requirements Key features you need are

bull Description of how you will protect subjects from research risks bull Plans to include

Women Children Minorities Analyses capable of showing intervention differences between men and

women and between minorities and non-minorities for phase III trials bull Data and safety monitoring plans bull Mandated reports

Failure to include the necessary information in your application may have dire consequences NIH has the option of not reviewing applications lacking the required documentation for protecting human subjects and reporting Also NIAID will not make an award until assurances are on file

Protection

Your research plan must show how you are dealing with risk and protecting subjects Create a separate section using the headers and addressing the topics on pages 19-20 of the 398 In it you will

bull Identify the characteristics of the study population or sources of research materials

bull Describe recruitment plans and potential risks and procedures for protecting against or minimizing risks including adverse events and informed consent

bull Describe potential benefits to the subjects and mankind

bull State the importance of the knowledge and why the risks are reasonable in relation to the benefits

In some cases you may qualify for an exemption from some requirements See the exemption definition to determine whether you do Justify any exemption in your plan See page 21 of the 398 for details

Inclusion

Reviewers will check to see that diverse populations are represented in your research plan unless the science precludes their participation State how you will ensure adequate numbers of minorities children and both genders including outreach mechanisms and justify any exclusions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 24: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

This needs to be built into the design of the project Use the ethnic categories on page 23 of the 398

After your human subjects section start new pages for the following plans

Inclusion analysis and outreach for women Inclusion analysis and outreach for children Inclusion analysis and outreach for minorities Data and safety monitoringDetection of differences in the intervention effect for women and minorities -- for NIH-defined phase III clinical only

Put your plans on separate pages they are not included in the page limit

In addition to the plans page 22 of the 398 specifies another section needed for allclinical research studies including subject selection rationale for exclusion dates ofenrollment outreach and the form pages

Monitoring

The degree of monitoring required by NIH corresponds to the level of risk in the research Data safety and monitoring boards (DSMB) are required for phase III trials Others types of studies have more leeway in the type of monitoring they use See page 27 of the 398

NIAID must also approve your monitoring plan see our Terms of award

Reporting

Note the reporting forms in the 398 are located between the NRSA and SBIR forms Plan your research so you will be able to complete these tables to meet annual reporting requirements

For NIH-defined phase III trials you will need to design analyses capable of showing intervention differences between men and women and between minorities and non-minorities unless you can provide documentation that such differences do not exist

Also pay attention to the minority subgroups required for clinical trial reporting

Training

Your application must include documentation that the investigators involved in the human subjects research have been educated in the responsible conduct of research See article NIH Still Calls for a Letter Showing Research Conduct Training

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 25: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

Certifications and assurances

If you are approved for funding your research plan must be certified by your organizationrsquos institutional review board (IRB) before we can issue an award unless exempt Though IRB approval is not required at the time of application you should start the process early because revisions and final approval can take time

Before you apply make sure your institution files a human subjects assurance online with the Office for Human Research Protections This can be done even before you send in your application See the Assurances and Certifications section of the PHS 398 on page 43

NIAID Special Terms of Award

NIAID has published its Terms of award policy requiring that monitoring of NIAID-supported clinical trials and studies be commensurate with the degree of risk to study subjects Applicants must meet these requirements in addition to those in the PHS 398

Review of Clinical Applications

In addition to the regular review criteria clinical research applications will also be reviewed for

bull Adequacy of plans to include both genders minorities and their subgroups and children as appropriate to the research goals Reviewers will also assess plans to recruit and retain subjects

bull Reasonableness of the proposed budget and duration in relation to the proposed research

bull Adequacy of the proposed protection for humans animals or the environment to the extent they may be adversely affected by the research

bull Adequacy of the proposed plan to share data if appropriate

Inadequately addressing these issues will negatively affect your priority score while failure to address them may result in your application not being reviewed

More Human Subjects Links

In addition to the 398 see these sites for more information

Glossary of human subject-related terms including a definition of what constitutes human subject research

Human subjects feature of March 2001 Council News

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 26: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

NIH human subjects reviewer guidance

Also see our Terms of award for NIAID-specific requirements

F Vertebrate Animals

As with human subjects applicants must also provide assurances that research animals are treated properly Awards cannot be made until NIH receives this information When preparing your application read the Assurances and Certifications sections of the PHS 398 carefully

Your application should include

- A detailed description of the proposed use of the animals

- A justification for the choice of species and number of animals to be used (describe any statistical methodology used for this determination)

- Information on the veterinary care of the animals

- An explanation of procedures to ensure that the animals will not experience unnecessary discomfort distress pain or injury

- Justification for any euthanasia method to be used

If the proposed research involves vertebrate animals your project must be reviewed and approved by an institutional animal care and use committee prior to funding For more information call OHRP (see above) or your institutes grant or contracts office

G Literature Cited

Refer to the literature thoroughly and thoughtfully but not to excess The publications you cite need not be exhaustive but should include those most relevant to your proposed research

Research proposals typically do not fare well when applicants fail to reference relevant published research particularly if it indicates that the proposed approach has already been attempted or the methods found to be inappropriate for answering the questions posed

Each citation must include the names of all authors (not et al) name of the book or journal volume number page numbers (not first page only) and year of publication

H ConsortiumContractual Arrangements

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 27: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

This section should briefly describe any consortium and contractual arrangements you have made with regard to the proposed research plan

The roles of individuals or organizations with whom you have made such arrangements should be noted and reference made to any letters from them that are included in the application Letters should describe the individuals or organizations understanding of the consortium or contractual arrangements

I Consultants

Careful selection and addition of consultants can add credibility to your application and greatly improve its quality A letter describing the willingness of an investigator to participate as a consultant to your project should be included in your application

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 28: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

IV Application Contents Other Than the Research Plan

Congratulations you have completed the hardest part of your application the research plan Now youre ready to work on the other parts

Keep in mind that some required information is changing Notices in the in the NIH Guide for Grants and Contracts and articles in the Council News newsletter will have the latest changes the most recent and important of which is the switch to a modular format for most grants For additional information on modular grants and applications go to NIHs modular Web page and the Guide notice

Abstract (Form BB)

Write this carefully because the NIH referral officer depends heavily on the abstract and title to assign your application to a peer review panel and to an IC (Institute or Center) for award Clarity will also help direct your application to the most appropriate primary reviewers and may encourage other reviewers in the study section to read it

Write your abstract after you have finished your research plan Make it a clear succinct summary of your project within the 200-word limit It should state your hypothesis objectives why the objectives are important and innovative and plans and methods for accomplishing your goals

Title

Make your title specific and detailed If your application is a revision do NOT change the title Stay within the 56-character limitation (this includes spaces between words)

Biographical Sketches (Form FF)

This section is your chance to showcase the knowledge skills and abilities of the key staff and consultants involved in your project Reviewers are concerned that the investigators and proposed staff have the proper experience with the proposed techniques They look carefully at the biosketches

With the advent of the modular grant and application the information in biosketches has changed Because other support is postponed until just before an award is made the biosketch section should include the aims of all past and current related research of key personnel as well as related publications Further the page limit is four pages

- Name and title

- Education -- institutions location degree(s) year conferred and field(s) of study

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 29: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

- Roles in other relevant current or past research

- Employment history in reverse chronological order dates places nature of position professional experience honors List only relevant publications in chronological order titles and complete references (include all authors)

- List all staff professional and nonprofessional even when not requesting salary Reviewers appreciate your giving estimates of the effort (not salary) for each person

Budget

Reviewers evaluate a requested budget for whether it is realistic and justified by the aims and methods of the project Complete the budget section after you have written your research plan and have a good idea of costs

Request only enough money to do the work Significant over- or underestimating suggests that you may not understand the scope of the proposed work Avoid requesting expensive equipment unless you absolutely need it and justify it well Dont request funds for equipment that is already listed in the resources section unless you can provide an adequate explanation Reviewers look for any discrepancies and will delete funds for equipment that should be available to you

Also make sure you calculate the salary of the principal investigator (PI) taking into account the government cap of $141300

Modular grants

NIHs adoption of the modular approach for most grant types involves changes to the applications budget section Prepare a modular grant application if you are requesting $250000 a year or less for direct costs (more expensive applications are nonmodular) for most grant types ndash see page 20 for a list

Request monies in $25000 modules Generally you request the same number of modules each year except for special needs such as equipment

NB Be sure to build any funding increases you foresee into the request Under the modular system there is no routine funding escalation for future years You must plan for the cost of the entire project when applying This is a major departure from the traditional process in which grantees received inflation-based annual budget increases

Resources

The resources section is a critical part of your application Show reviewers that you have the necessary equipment space support staff and other facilities to conduct the

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 30: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

research Dont assume that reviewers know your facilities have gas vacuum centrifuges scintillation counters gel apparatus computers autoclaves shop animal facilities secretarial and financial support or anything else you need for your research

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 31: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

V Writing and Formatting

Read PHS 398 carefully and follow its guidelines to the letter Formatting is strictly enforced Dont risk having your application returned because you exceeded the page limits or used an improper font or font size

Edit thoroughly Make sure your work is letter perfect If you cannot meet the application deadline comfortably consider delaying to the next receipt date

Follow the format in the instructions Reviewers expect the research plan to be organized exactly as described in the instructions you do not want to upset these expectations Label sections exactly as in the instructions A Specific Aims B Background and significance etc

Conduct your own peer review get outside opinions Find colleagues in your field who are experienced and successful grant writers and preferably reviewers (members or former members of NIH study sections) The more critical they are the better Its better to know the problems before you send in your application than learn about them after the review when your grant gets an unfundable score

Page Limitations

Type (font) Size and Spacing

Type setting (font size and spacing) requirements are strictly enforced Avoid alienating reviewers with hard-to-read type The minimum specifications are in the 398 They include 10-point font size for certain fonts though your application may be better received with 11- or 12-point font

Font size in figures and tables may be smaller but must be readily legible

Writing Tips

Use the active rather than passive voice For example write We will develop a cell line not A cell line will be developed

Keep related ideas and information together eg put clauses and phrases as close as possible to preferably right after the words they modify

Simplify and breakup long involved sentences and paragraphs In general use short simple sentences they are much easier on the reader Your goal is communication not literature

Edit redundant words and phrases Proofread thoroughly Look carefully for typographical and grammatical mistakes omitted information and errors in figures and

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 32: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

tables

Sloppy work will definitely suffer in review Reviewers feel that if the application is sloppy or disorganized the applicants research may be as well

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 33: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

VI Submitting Your Grant Application

Receipt Date

NIH receipt dates have been changed so the post mark on the application now counts as the date for meeting the deadline Go to the Review Receipt and Award Table for receipt dates for various types of grant applications

Cover Letter

Its a good idea to include a cover letter with your application The letter should state the title of the application briefly describe the focus of the research proposed and if applicable identify the program announcement (PA) or request for applications (RFA) to which you are responding Also you may include the names of people whom you feel should not be allowed to evaluate your application (the section on Review of Research Project Applications page 25 discusses this subject in more detail)

Requesting an SRG and InstituteCenter

Your cover letter can and often should request that your application be reviewed by a specific Scientific Review Group (SRG) administered by a specific Institute or Center or both NIH usually accommodates these requests but reserves the right to make the final decision

You can discuss referral decisions with the CSR Referral Office at 301435-0715 as well as with the assigned SRA after referral to an SRG has been made At least the first time through you should probably let the NIH referral system decide which SRG will review your application NIH referral staff are correct the vast majority of the time

Modular Grants and Applications and Just in Time

The move to modular grants and applications extends NIHs just-in-time (JIT) processes which postpone your sending in certain information when submitting a grant application until an award is likely decreasing the paper burden on you and your institution

The modular approach is being used for research project grants (R01) small grants (R03) academic research enhancement awards (R15) exploratory or experimental grants (R21) small business technology transfer phase I (R41) and small business innovation research phase I (R43) grants as well as competing supplements and applications responding to RFAs

For initiatives such as RFAs and program announcements you will need to refer to individual solicitations (and also what NIH calls notices) in the NIH Guide for Grants and Contracts for specific instructions JIT is used for career awards (K) which do not follow modular procedures

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 34: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

VII Problems and Concerns Commonly Cited by Reviewers

Below is a list of the most common reasons cited by reviewers for an applications lack of success

Lack of significance to the scientific issue being addressed

Lack of original or new ideas

Proposal of an unrealistically large amount of work (ie an overambitious research plan) Scientific rationale not valid

Project too diffuse or superficial or lacks focus

Proposed project a fishing expedition lacking solid scientific basis (ie no basic scientific question being addressed)

Studies based on a shaky hypothesis or on shaky data or alternative hypotheses not considered Proposed experiments simply descriptive and do not test a specific hypothesis The proposal is technology driven rather than hypothesis driven (ie a method in search of a problem)

Rationale for experiments not provided (why important or how relevant to the hypothesis)

Direction or sense of priority not clearly defined ie the experiments do not follow from one another and lack a clear starting or finishing point

Lack of alternative methodological approaches in case the primary approach does not work out

Insufficient methodological detail to convince reviewers the investigator knows what he or she is doing (no recognition of potential problems and pitfalls)

The proposed model system is not appropriate to address the proposed questions (ie proposing to study T-cell gene expression in a B-cell line)

The proposed experiments do not include all relevant controls

Proposal innovative but lacking enough preliminary data

Preliminary data do not support the feasibility of the project or the hypothesis

Investigator does not have experience (ie publications or appropriate preliminary data) with the proposed techniques or has not recruited a collaborator who does

The proposal lacks critical literature references causing reviewers to think that the

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 35: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

applicant either does not know the literature or has purposely neglected critical published material

Not clear which data were obtained by the investigator and which have been reported by others

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 36: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

VIII Referral and Assignment of the Application

When NIH receives an application two things happen First it referred to a scientific review group (SRG) for review and second it is assigned to an institute or center for possible funding These steps are very important to the fate of a grant application Competition for funding often varies among ICs so assignment choices may determine whether your application is funded

Please be aware that you have the right to request the referral and assignment of your application to the organizations you feel would serve it best NIH data show that applicants can successfully selfassign and self-refer to an SRG and institute

Much of the information you need to know to do this is available and the rest you can get by calling program administrators in NIAID (see our program and staff listing) or in other institutes (see the NIH home page) Information about which scientific areas the various SRGs of the Center for Scientific Review (CSR) handle is invaluable It is readily available either on the web from most institutions or from the CSR Grants Office 301435-0714 You can also find lists of study section members on the Web

To discuss referral decisions with the CSR referral office call 301435-0715 you can also call the SRA in charge of the review

You should also discuss your project with a program officer of the institute that supports your area of research before requesting assignment to an IC You can request primary and secondary assignments in your cover letter

If you do not self-assign a referral officer in CSR forwards your application to an SRG and NIH IC based on NIH referral guidelines The referral officer may also make secondary assignments to other ICs that may be interested in funding the application

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 37: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

IX Review of Research Project Applications

This section describes what happens to grant applications during initial peer review Your application can be reviewed in one of two places either in NIHrsquos Center for Scientific Review (CSR) or in an institute

Scientific Review Groups

Whereas most investigator-initiated applications are reviewed by a scientific review group (SRG aka study section) in CSR institute SRGs review applications and proposals that address institute-specific needs These are typically program projects (P) cooperative agreements (U) training (T) and research career (K) grants and applications responding to requests for applications and requests for proposals

Both in CSR and institutes chartered SRGs are composed of scientists who have a broad range of scientific expertise in a general area Most SRGs in CSR meet three times a year for one to three days All SRGs are managed by an institute or CSR scientific review administrator (SRA)

Review Criteria

In June 1997 NIH established new review rating criteria the factors reviewers weigh when assessing the merit of an application The following criteria are used by all NIH SRGs for the initial peer review of research project grant applications

Significance Approach Innovation Investigator Environment

To read more about peer review issues and policies go to httpwwwnihgovgrantspeer peerhtm Your Institute program and review staff are also good sources of information

Cover Letter

Your application can include a cover letter in which you can identify people who should not review your application because of potential conflict of interest (eg someone who is a competitor or with whom you have a long-standing scientific disagreement)

State the reasons for your objections to specific reviewers This strategy may be useful when you submit a revised application and you believe there is a problem with a reviewer from the previous review

Administrative Review

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 38: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

Before sending applications to members of a peer review panel SRAs examine the administrative components of the applications When an applicant has not provided certain required information (such as a biographical sketch for a key investigator) the SRA has the option of contacting the applicant to request the missing information

If you receive such a request consider it an opportunity to strengthen your application A rapid response will ensure that peer reviewers receive the additional information in time to fully consider it prior to the review meeting

At the Peer Review Meeting

Four to six weeks before an SRG meets the SRA sends each SRG member a copy of the applications to be reviewed

Usually the SRA assigns at least two members to be primary reviewers and write critiques before the meeting The SRA will also ask one or more members to serve as readers who identify strengths and weaknesses of applications Other SRG members may or may not read the application prior to the review

How Priority Scores Are Determined

If your application warrants a full discussion at the review meeting (see below for reasons it may not) reviewers present their evaluations and indicate their level of enthusiasm by suggesting a priority score where 10 is the best and 50 is the worst

Your application is then opened for discussion and differences of opinion are explored Then study section members each assign a score The priority score on your summary statement is the average of the individual scores multiplied by 100

Applications that lack substantial scientific merit or lack information do not receive a priority score Three categories of applications do not receive a full review a priority score and a full summary statement

1 Unscored Refers to applications whose merit is judged to be in the bottom half of the group of applications (priority scores between 30 and 50) being reviewed by a scientific review group (Under NIHrsquos streamlined review applications are subjected to a preliminary evaluation to determine their scientific merit relative to that of the group of applications under review) Applications judged to be in the lower half are not subject to full discussion and are not scored The applicant receives the assigned reviewers critiques and a resume of the discussion

2 Not Recommended For Further Consideration (NRFC) Used for applications found to have no significant and substantial scientific merit In addition applications that include clinical research with inadequate protection against risks to human subjects can be classified in this category

3 Deferred In some instances the scientific review group is unable to make an

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 39: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

adequate determination of the scientific merit of an application due to lack of adequate information In such cases the group can ask that the application be deferred generally to a later review date to allow additional time to obtain the information from the applicant either by telephone or by the submission of additional material (or in some cases a site visit or an outside opinion) Deferred applications are ordinarily reviewed during the next review cycle Occasionally a deferred application can be reconsidered later in the same meeting if the information can be obtained by calling the applicant

Summary Statements

Prepared by the SRA summary statements include the reviewers critiques (as feedback applicants may use to revise their applications) a summary of the deliberations an average priority score recommended changes in the budget and administrative comments if any The roster included with the summary statement lists the reviewers but does not identify which were assigned reviewers (this is done to protect confidentiality)

Institutes mail summary statements to applicants roughly six to eight weeks after the SRG meeting and provide them to the program staff member responsible for the application Itrsquos a good idea to wait until after you receive and review your summary statement before calling your program officer to learn if your application is likely to be funded

Appeal

You can appeal a review if you feel the review process was seriously flawed Flawed means errors due to reasons such as conflict of interest or bias Differences in scientific opinion cannot be appealed If you believe appealable errors occurred talk with your program officer to discuss your best course of action (for a listing of NIAID programs and staff) For more information about the NIH appeals process go to the NIH Guide for Grants and Contracts notice and to our newsletter article

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 40: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

X How Funding Is Decided

Several factors come into play when NIH institutes and centers (IC) decide which applications to fund

Paramount among them is an applications percentile ranking derived from its priority score the outcome of peer review In addition an IC considers the relevance of the proposed project to its mission and the availability of funds

How Paylines Work

Some ICs such as NIAID set a payline which is a funding cutoff point This means that NIAID funds all applications with percentiles better than the payline whereas those worse than the payline (with the exception of some high-priority applications at the payline margin) are not funded or funding is deferred until later in the fiscal year

Several things are important to know about paylines One is that the payline is a budget management tool It may change as the fiscal year progresses and the precise amount of funds available to the Institute becomes better known (for a more in-depth discussion of paylines and percentiling see our newsletter article) Second many more grants get funded than those within the payline What is often referred to as the payline is actually the payline for R01 grants only Other types of awards including training and bridge awards are not affected by the R01 payline and do not affect it

Third paylines vary among ICs So a percentile that is not fundable in one institute may be fundable in another Thats why the assignment of your application is so important

You can improve your likelihood of gaining funding by requesting that your application receive primary or secondary assignment to an IC seeking applications in your research area (for NIAIDrsquos program areas see the program and staff listing) We also list NIAIDrsquos concepts on the web to give you insights into the Institutersquos high priority areas

For more information about requesting assignment to an IC contact the CSR referral office at 301435-0715

Second Level Peer Review

In the NIH peer review process applications undergo a second level of peer review At NIAID this is carried out by the Institutes advisory Council Council members look at summary statements of grants within the payline especially for applications with special concerns such as human subject issues

They also consider a small number of high-priority grants at the payline margin that will be paid selectively Council may also consider complaints or other information from applicants regarding the quality of the review

Possible Outcomes of Secondary Review

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 41: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

Following Council review NIAID takes one of four actions for an application

1 Approved for funding 2 Primary responsibility transferred to another IC that agrees to fund it 3 Kept active for later decision usually at the end of the fiscal year 4 Not funded file is closed

Why Applications Are Kept on Hold

ICs disperse funds by fiscal year (October 1 through September 30) Payment of too many applications following the first (SeptemberOctober) or second (January February) review cycles in the fiscal year could preclude payment of better applications later

Thus early in the fiscal year ICs usually fund only applications highly likely to rank in the fundable range for all applications received for the year Typically they defer decisions for borderline applications until after the third review cycle in June or July If funds are still available ICs may then fund these still active but unfunded applications in percentile order

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 42: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

XI When You Have Not Obtained Funding

What if you submit a grant application and it does not get funded Competition for NIH funds has become increasingly tough and it is common not to succeed at the first attempt Be prepared to revise and resubmit your application

Be persistent Data show that over half of all NIH applicants eventually get funded Revising the application is your opportunity to address reviewersrsquo concerns Many applications succeed on the second or even third submission (the limit is three)

Most Common Reasons for a Low Score (in priority order)

- Lack of new or original ideas

- Hypothesis ill-defined superficial lacking unfocused or unsupported by preliminary data

- Methods unsuitable or defective and not likely to yield results

- Data collection confused in design inappropriate instrumentation poor timing or conditions

- Data management and analysis vague unsophisticated

- Inadequate expertise or knowledge of field for PI or too little time to devote to the work

- Poor resources or facilities limited access to appropriate patient population

From Why clinical research grant applications fare poorly in review and how to recover Cuca JM McLoughlin WJ Cancer Invest 19875(1)55-8

When to Revise

How do you know when to revise your application and resubmit or when to begin over with a new idea If reviewers thought your basic idea was interesting and important the application may be worth revising However if they felt the hypothesis was weak begin with a new idea

If the problems are repairable revise the application and resubmit it to the same study section

Common fixable problems - Poor writing - Insufficient information experimental details or preliminary data - Significance not convincingly stated

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 43: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

- Research not shown to be feasible by the proposed staff - Insufficient discussion of obstacles and alternatives approaches

Not fixable or more difficult problems - Philosophical issues eg the reviewers believe the work is not significant - Hypothesis is not sound or not supported by data presented - Work has already been done - Methods proposed were not suitable for testing the hypothesis - Suitable expertise was not available on the SRG that reviewed your grant - Perceived bias (Bias is rare Reviewers will be alert to bias and argue against it

vigorously if they perceive that a competitor is not being fair In addition SRAs are also alert to signs of potential bias in SRG members)

If the problem lies with the SRG revise the application and request review by a different SRG See directions under Cover Letter page 20 Give reasons for the request (lack of reviewer expertise lack of interest in the subject differing philosophies (eg a molecularly oriented review group reviewing a clinical application) Try to suggest an alternative SRG

For fatal flaws and weaknesses rethink your idea and start over

Revising Your Application

Read and reread the summary statement Identify the problems Before you start revising talk with your program administrator (go to NIAIDs program and staff) to review your summary statement and get advice Also ask someone in your institution who is experienced in grantsmanship and not involved in your proposed research to review your application summary statement and revision plans

Respond to reviewersrsquo comments

The key to successfully revising your application is to respond to the comments and suggestions of the reviewers Address reviewers comments point by point you need not agree with all points but you must address them If you disagree with the reviewers explain why and provide additional information if needed Include any new preliminary data you may have

Use page numbers and other identifiers so reviewers can easily find where you have added new data or revised experimental approaches A bar in the margin is a good way to show where revisions are highlight new sections with indenting bracketing underlining or change of type

Revised applications must include an introduction limited to one page and not counted in the 25-page limit Help reviewers understand your revisions by following the instructions in the PHS 398 application kit Your summary should state substantial

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 44: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

additions deletions and changes in the revised application and address the main criticisms in the summary statement

Even if you respond adequately to the criticisms in the summary statement you are not guaranteed an award This may happen because a summary statement is not meant to be an exhaustive critique some problems discussed by the reviewers may not appear in it Also when you make changes you risk introducing new problems

Finally membership in scientific review groups changes Your application may be seen by some new reviewers who may have different views of your project

If you still dont get funded after the second try try again Data show that persistence pays off NIH allows you to revise and resubmit the application for review two more times

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 45: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

XII When Your Application Is Approved for Funding

If an institute or center (IC) approves your application for funding NIH staff will contact you or your institution to discuss when the award is to start and the funding level of project You may also be asked to submit additional information eg updated information on budget costs and other support or information and certification on institutional approval of human and animal research (see Modular and Just in Time page 20) It is important to send theses items to us as soon as possible since issuing the award may be contingent on our receipt of this information from you

Upon satisfactory completion of all requirements the IC sends your institution a Notice of Grant Award which states the amount of funding for current and future years start and end dates and the terms and conditions of the award

If it is your institutions is first NIH award you will also receive a Welcome Wagon letter with lots of important information on what to do Read it carefully

There are many rules and procedures pertaining to grants In addition to the sources listed below you can read more about rules and regulations in the PHS Grants Policy Statement

For updates on changes in policies and procedures read the notices published weekly in the NIH Guide for Grants and Contracts

Documentation

Two items of special importance to NIH are the animal welfare and protection of human subjects assurances Most universities that have received grants or contracts from NIH have an assurances on file with the Office for Human Research Protections (OHRP) If your institution does not have a Federalwide Assurance the awarding office will contact OHRP and your institution must negotiate an assurance before the award is made

Human subjects

For more information concerning the human subjects assurance contact OHRP at

Office for Human Research Protections 6100 Executive Boulevard MSC 7507 Suite 3B01 Rockville MD 20892-7507 301496-7005

And find a wealth of guidance documents on the Web

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 46: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

Animals in Research

For information on animal welfare assurance requirements or to request the publication Public Health Service Policy on Humane Care and Use of Laboratory Animals contact

Office of Laboratory Animal Welfare Division of Assurances 6705 Rockledge Drive RKL1 Suite 1050 MSC 7982 Bethesda MD 20892-7982

Or see the Web site at Office of Laboratory Animal Welfare

What You Can and Cannot Pay for on a Grant

In most cases your grant support will pay for direct (project-specific) costs plus the indirect costs negotiated for your institution Information on direct and indirect costs that may be charged to a grant are outlined in five sets of cost principles

OMB Circular A-21 Institutions of Higher Learning OMB Circular A-87 State and Local Governments OMB Circular A-122 Nonprofit Organizations 45 CFR Part 74 App E Hospitals FAR 48 Subpart 312 For-Profit Organizations

For more information see also the PHS Grants Policy Statement Check to see what expenditures are allowed With the advent of modular grants NIH no longer requires you to request approval to rebudget funds

Terms and Conditions of Award

Acceptance of the grant means you agree to be bound by its terms and conditions (To learn more about these see the PHS Grants Policy Statement) As is stated in yourNotice of Grant award your grant is subject to terms and conditions in

Grant program legislation Grant program regulations Notice of Grant Award (including terms and conditions)PHS Grants Policy Statement 45 CFR Part 74 or 45 CFR Part 92

NIH provides the terms and conditions as an attachment to the Notice of Grant Award It is important that you review the entire document when setting up project expenditures or your scientific plan

Reporting Requirements

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 47: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

Financial Status Report When required Financial Status Reports are due 90 days after the close of a budget period on Standard Form (SF) 269 or 269A For NIHawards send the Financial Status Report to the NIH Division of Financial Management for review and acceptance which forwards them to the awarding institute

Address and phone number are

NIH DFMFAABGrants Section Building 31 B1B11 Bethesda MD 20892-2052 301496-5287

For grants under the Streamlined Noncompeting Application Process (SNAP) a Financial Status Report is required only at the end of a competitive segment rather than annually For more information on these modified reporting requirements go to httpwwwnihgovgrantspolicysnap3htm or contact your grants management specialist listed on your notice of grant award

Progress Report NIH grants require a minimum of an annual report due to the Institute as part of the noncompeting application (PHS Form 2590) 60 days before the start of each budget period Final Progress reports are due 90 days after the expiration or termination of the grant Invention Report NIH grants must comply with government-wide patent regulations as stated in Title 37 CFR part 401

Inventions must be reported in any noncompeting or competing continuation application and included on the Final Invention Statement and Certification required within 90 days after the expiration or termination of support

Invention reporting NIH now enables you to fulfill your invention reporting requirements online using a system called Edison

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 48: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

Checklists

BEGINNING CHECKLIST Do I know the field and its literature well Do I know the important research questions in my field Is the field overpopulated with researchers Did I check the literature to make sure the project Im considering has not been done before or has been done and its methods judged to be inadequate Did I discuss my proposal with program staff in the appropriate institute

HYPOTHESIS CHECKLIST Is my proposal driven by a strong hypothesis What specifically am I setting out to prove Is the central research question important to the field Is the hypothesis testable by current methods Did I state my hypothesis in the abstract and specific aims section

RESEARCH PLAN - PLANNING CHECKLIST Answer these questions when you develop your research plan Is my plan hypothesis driven Does my project have a coherent direction Are the aims of the project I am considering achievable Does my project relate to a central focus Have I tried to do too much

RESEARCH PLAN - PROCESS CHECKLIST Answer these questions when you write your plan Am I presenting the information logically and clearly Am I highlighting the importance and innovation of my project Am I following the exact format in the specified instructions Am I explaining what gaps in science my project would fill Am I referring to the literature thoroughly and thoughtfully Did I state my hypothesis in the specific aims and in the abstract and provide a logical

rationale for the hypothesis Did I prepare an appropriate budget having checked the notices in the the NIH Guide for Grants and Contracts for any new requirements Did I provide all necessary information for human subjects and animals Did I include a timetable for the proposed research

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 49: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

SPECIFIC AIMS CHECKLIST Do my specific aims and objectives support and test my hypothesis Are they tightly focused Did I present alternatives to my hypothesis and the reasons I chose the one I did Can my objectives be assessed by the review committee

BACKGROUND AND SIGNIFICANCE CHECKLIST Did I show how my research is innovative Did I state how it will increase knowledge in the fieldDid I include background information about the field Does the literature section show reviewers my understanding of the field Did I show that I know the gaps or discrepancies in the field Did I identify the next logical research beyond this application

PRELIMINARY DATA CHECKLIST Do the preliminary data support the hypothesis to be tested Do they show the feasibility of the project Did I explain how the results from my preliminary studies are valid and how they will be expanded Did I interpret my results critically and provide alternative meanings to them

DESIGN AND METHODS CHECKLIST

General Does each experiment correspond to one of the specific aims and is it stated in the same order Do the experiments follow a logical sequence Did I estimate what I expect to accomplish each year and state foreseeable delays Did I describe any hazardous procedures situations or materials and appropriate precautions Did I include supporting data Does my appendix include publications showing my use of the methods I have described

Approach Are the methods I chose appropriate to achieve the specific aims Did I show why each experiment is important or how it is relevant to the hypothesis Will reviewers think I am knowledgeable about my methods Did I justify my choice of methods in detail if they are innovative

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 50: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

Did I support my methods with data Did I outline my methods in detail Did I point out and provide solutions for potential problems Is my proposed model system appropriate Did I address difficulties I may encounter with the proposed approaches show I can handle them and propose solutions and alternatives Did I consider how the limitations of the approaches may affect my results and data Did I address possible problems and limitations of the procedures and propose solutions Did I use enough detail Did I include all relevant controls

Results Did I show I am aware of the limits to and value of the kinds of results I expect Have I convinced reviewers I will be able to interpret my results Have I enlisted help from a statistician if needed and discussed statistical methods to be used Did I define the criteria for evaluating the success or failure of a specific test

ABSTRACT CHECKLIST Did I stay within the 200-word size limitation Did I state my hypothesis Does my abstract describe my objectives Does the abstract state the importance of the research and how it is innovative Does it outline the methods I will use to accomplish my goals

BIOSKETCHES CHECKLIST Does each biosketch include all required details (name title education and employment history) Are roles in other relevant research included Did I describe the aims of current and recent past support Have I included the biosketches in the proper order (principal investigator then all others in alphabetical order by last name) Have I kept to the 4-page limitation

BUDGET CHECKLIST Is my budget realistic and appropriate for the aims and methods of the project Could any of my requests appear to be extravagant or include resources already available to me

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST
Page 51: NIGMS -- Tips for New NIH Grant Applicants Page 1 …sam.research.sc.edu/pdf/Eseries/Coelho_Grant_Writing_Ref.pdfThese tips were gathered by NIGMS staff members. Suggestions for additions

Does the PIs salary exceed the government cap of $141300

RESOURCES CHECKLIST Does my description of my resources show adequate equipment space and support staff to conduct the research

WRITING CHECKLIST Have I carefully read the instructions and followed the rules such as those for page limitations and type (font) size Did I follow the format outlined in PHS 398 Is the writing as clear and concise as it can be Have I edited and proofread the application thoroughly Does the application have a pleasing presentation eg no crowding of information and well organized Is the type clean and legible Did I have several colleagues critique the application

REVISING CHECKLIST Did I read the summary statement and identify the problems Did I address reviewers comments point by point identifying changes clearly Did summarize substantial additions deletions and changes in one page Did I clearly distinguish sections that are the same in the previous application and those that are different showing precisely where I added new information If I disagreed with the reviewers did I explain why and provide additional information Did I follow the instructions in PHS 398

  • howtopdf
    • Third Edition amended August 30 2001
    • The Original How to Write a Research Grant Application
      • I Before You Begin
          • If the answer is yes
          • Protection
          • Inclusion
          • Monitoring
          • Reporting
          • Training
          • Certifications and assurances
            • Most Common Reasons for a Low Score (in priority order)
            • BEGINNING CHECKLIST
            • HYPOTHESIS CHECKLIST
            • RESEARCH PLAN - PLANNING CHECKLIST
            • RESEARCH PLAN - PROCESS CHECKLIST
            • SPECIFIC AIMS CHECKLIST
            • BACKGROUND AND SIGNIFICANCE CHECKLIST
            • PRELIMINARY DATA CHECKLIST
            • DESIGN AND METHODS CHECKLIST
            • General
            • Approach
            • ABSTRACT CHECKLIST
            • BIOSKETCHES CHECKLIST
            • BUDGET CHECKLIST
            • RESOURCES CHECKLIST
            • REVISING CHECKLIST