Behavioral HealthBehavioral Health

Program of Excellence

The Structure of NIH Grant Applications

Dan Hoyt

Department of Sociology

Overview

• Review Criteria

• The Research Plan

• Other components of the application

• PHS 398 or SF424 submission

• Peer Review

• Funding

Review Criteria

• Significance

• Approach

• Innovation

• Investigator

• Environment

SIGNIFICANCE

• Does this study address an important problem?

• If the aims of the application are achieved, how will scientific knowledge be advanced?

• What will be the effect of these studies on the concepts or methods that drive this field?

APPROACH

• Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project?

• Does the applicant acknowledge potential problem areas and consider alternative tactics?

INNOVATION

• Does the proposed research employ novel concepts, approaches or method?

• Are the aims original and innovative?

• Does the project challenge existing paradigms or develop new methodologies or technologies?

INVESTIGATOR

• Is the investigator appropriately trained and well suited to carry out this work?

• Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)?

ENVIRONMENT

• Does the scientific environment, in which the work will be done, contribute to the probability of success?

• Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements?

• Is there evidence of institutional support?

The Research Plan

a) Specific Aims

b) Background & Significance

c) Preliminary Studies/Progress Report

d) Research Design & Methods

e) Human Subjects

f) Vertebrate Animals…..

Reference: Ann Hohmann, NIMH

SPECIFIC AIMS

Purpose: To present your research idea. Why it is important, why you should do it, and what do you propose to accomplish

• Propose 3-5 aims - not a dozen - all related to 1 overall goal. That goal must address an issue in science. In other words, you must convince the review committee that your question is the next best step in science.

BACKGROUND AND SIGNIFICANCE

Purpose: To convince your reviewers you understand the research questions in the larger scientific context

• Let the reviewers know that you understand the problem but do not make this a bibliographic lecture or describe individual studies in detail.

• Set up a theoretical and conceptual framework for your research. You must show that you have a very good scientific reason for proposing the research.

• This section provides the rationale and justification for the research.

PRELIMINARY STUDIESPurpose: To show your reviewers you and your team have experience doing research and can be good stewards of public research funds

• Previous published analyses and/or pilot work directly related to the proposal. This helps to establish feasibility of proposed work and the ability of research team to carry out work.

• List most salient related work by all members of research team.

• Explicitly relate prior work to goals and objectives of proposed study.

RESEARCH DESIGN AND METHODS

Purpose: To convince your reviewers you have completely thought through: (1) how to answer the questions posed in the Specific Aims section; and (2) the potential problems in your design and how you will deal with those problems

• Justify all instruments. Provide information on reliability of instruments. Provide copies in appendix.

• Justify the sample size through a power analysis. Discuss how you will take into account attrition; how will it affect the power? How will you track difficult to find subjects?

RESEARCH DESIGN AND METHODS

• Thoroughly discuss the sampling approach and implications. Is the sample nested? How will attrition affect conclusions?

• Provide a step-by-step explanation of any intervention. Tell the reviewers exactly what will happen to subjects in the control and experimental groups. Discuss in detail the training plans for those who will provide the intervention and for those who will perform the data collection.

• If descriptive, provide similar detail on the survey methods. If longitudinal, provide considerable detail on retention of subjects (i.e., tracking, incentives).

RESEARCH DESIGN AND METHODS

• Specifically discuss the weaknesses of your design. If you don't acknowledge the limits of the study, it is likely to be assumed that you are not aware of them.

• Provide a step-by-step analysis plan. Tie each hypothesis or specific aim to an analytic strategy. Be clear on why you select this particular analytic method and why it is the best approach for assessing the respective research question.

• Don't use analytic methods just because they are in vogue. Demonstrate that you know how to use the methods (a good use of preliminary studies section examples).

RESEARCH DESIGN AND METHODS

• Don't propose methods that you don't have the expertise to use. For particularly complex methods, the person with the expertise should either be on-site or easily accessible.

• Choose methods that are appropriate to answer the questions you are asking with the data you will have available to you. Consider how much missing data you are likely to have, how the analytic methods you have chosen will deal with those missing data points, and what effect your choice will have on the conclusions you can reach.

• Include and discuss an implementation timeline (such as a Grant chart)

Other Elements

TITLE AND ABSTRACT• The title and abstract are the sources of

information for referring your application to a particular program and review committee - contact staff.

• Construct a carefully worded statement describing the main purpose of the research, hypotheses/goals, methods of data collection and analysis, and significance.

Budget

• Make the budget realistic and appropriate for the scientific goals. Don't pad and don't propose cutting too many corners (makes you look naive).

• Itemize the budget for each year. Hold increases in continuation costs to 4% (NIH cost containment policy).

• Justify each item. Make it possible for reviewers to determine what costs are associated with what aspects of the project.

• Insure that specific tasks are clearly related to personnel, time, and budget.

• Avoid small allocations of time among a large number of investigators; insure an adequate time commitment of the Pl, project director, and statistician - in ALL years of the project.

Application Form

• The standard form has been the PHS 398

• Instructions and forms can be downloaded from the internet.

http://grants.nih.gov/grants/funding/phs398/phs398.html

• Annotated example of a completed PHS 398 grant

http://www.niaid.nih.gov/ncn/grants/app/app.pdf

SF424 (R&R)

• The SF424 (R&R) is an application form that is comprised of common data elements developed for use by Federal agencies funding Research and Research-Related programs

• Also provides a consistent electronic submission process through Grants.gov

• Instructions and forms:

http://grants1.nih.gov/grants/funding/424/index.htm

SF424 (R&R)

• Application components include specific data fields as well as multiple attachments

• Most attachments are text

• NIH requires PDF for text attachments

• Attachments can be generated using any word processing software but will need to be converted to PDF before they can be attached to the actual application form

Peer Review: Center for Scientific Review

Two-step process– Study sections (CSR) – Primary, secondary reviewer

– Council (Center or Institute)

Review Criteria – Roadmap emphasis– 1. Significance. 2. Approach – 3. Innovation 4. Investigators – 5. Environment.

http://www.csr.nih.gov/

Mock Grant Review Panel

• One of the common questions among new investigators is what happens in the review of your grant application.

• NIH has a web site that provides an online video of a mock grant review panel.

• Recommend that you check out this site, download and read the sample application materials and then watch the review session video.

www.drg.nih.gov/video/video.asp

Peer Review Scoring

• 1 – 5 (1 = excellent)

• Priority score - Rating of intrinsic scientific merit of the proposed research (100 – 500)

• Percentile - the relative rank of each priority score (along a 100.0 percentile band) among the scores assigned by a particular study section

• Streamlining – Up to half of proposals unscored (remaining should be 100 – 300)

Feedback

• “Pink sheets”– Summary– Reviewers feedback– Contact Scientific Review Administrator

(SRA) and Program Manager for additional feedback

• Reapply– Respond to comments in “Introduction”

2005 Grant Funding by I/C

Institute or Center

Success Rate Base

Number Awarded

Total Cost AwardedSuccess

Rate

NIA 1,997 376 $128,677,569 18.80%

NIAAA 666 203 $65,869,642 30.50%

NICHD 2,835 505 $142,877,320 17.80%

NIDA 1,727 376 $124,806,047 21.80%

NIMH 2,710 569 $178,136,443 21.00%

FY Totals 43,069 9,599 $3,405,275,239 22.30%

New Grant Funding - 2005

ActivitySuccess

Rate Base

Number AwardedTotal Cost

AwardedSuccess

Rate

R01 21,745 3,894 $1,392,849,232 17.90%

R03 3,307 723 $55,684,224 21.90%

R21 8,483 1,495 $291,665,902 17.60%

All New 35,874 6,739 $2,178,025,344 18.80%