Working with NIH Program Officials: Pre-Award & Post-Award

Shawn Gaillard, NIGMSand

Francisco Sy, NIMHD2013 NIH Regional Seminar, Baltimore, MD

NIH Overview

Pre-award: Communication w/ Program Staff

Post-award: Communication w/ Program Staff

OUTLINE

NIH Overview

“To win the future, America

needs to out-educate,

out-innovate, and out-build

the rest of the world.” President Barack Obama,

Weekly Address February 5, 2011

U.S. Dept. of Health & Human Services5

Administration forChildren and Families

(ACF)

Administration forChildren and Families

(ACF)

Food and DrugAdministration

(FDA)

Food and DrugAdministration

(FDA)

Health Resourcesand Services

Administration(HRSA)

Health Resourcesand Services

Administration(HRSA)

Secretary of Health and

Human Services

Secretary of Health and

Human Services

Administration onAging(AoA)

Administration onAging(AoA)

Center for Medicare &

Medicaid Services(CMS)

Center for Medicare &

Medicaid Services(CMS)

Indian HealthServices

(IHS)

Indian HealthServices

(IHS)

National Institutesof Health

(NIH)

National Institutesof Health

(NIH)

Agency for Healthcare Research

and Quality(AHRQ)

Agency for Healthcare Research

and Quality(AHRQ)

Centers for Disease Controland Prevention

(CDC)

Centers for Disease Controland Prevention

(CDC)

Substance Abuse andMental Health Services

Administration(SAMHSA)

Substance Abuse andMental Health Services

Administration(SAMHSA)

Agency for ToxicSubstances andDisease Registry

(ATSDR)

Agency for ToxicSubstances andDisease Registry

(ATSDR)

NIGMS

~$31 Billion~$31 BillionFiscal Year 2013Fiscal Year 2013

Annual BudgetAnnual Budget

Intramural Research

R&D Contracts

Research Centers

Other Research

All Other Training

Mgmt & Support3%

3%

5%

6% Research Project

Grants (RPG)53% 10%

11%

11%

The mission of the NIH is to uncover new knowledge that will lead to better health for everyone by:

Conducting research in our own laboratories (Intramural)Providing support for research outside of our labs (Extramural)Training future research investigatorsCommunicating medical information to public

National Institutes of Health

NIGMS

Office of the Director Office of the Director

National Libraryof Medicine

National Libraryof Medicine

Center for InformationTechnology

Center for InformationTechnology

Center for Scientific Review

Center for Scientific Review

FogartyInternational

Center

FogartyInternational

Center

National Instituteof Arthritis andMusculoskeletal

and Skin Diseases

National Instituteof Arthritis andMusculoskeletal

and Skin Diseases

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Dental andCraniofacial

Research

National Instituteof Dental andCraniofacial

Research

National Institute onDeafness and Other

CommunicationDisorders

National Institute onDeafness and Other

CommunicationDisorders

National EyeInstitute

National EyeInstitute

National Heart,Lung, and Blood

Institute

National Heart,Lung, and Blood

Institute

National Instituteon Alcohol Abuseand Alcoholism

National Instituteon Alcohol Abuseand Alcoholism

National CancerInstitute

National CancerInstitute

National Instituteon Drug Abuse

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

National Instituteof Environmental Health Sciences

National Instituteof Mental Health

National Instituteof Mental Health

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof Allergy and

Infectious Diseases

National Instituteof Allergy and

Infectious Diseases

National Center on Minority Health and Health Disparities

National Center on Minority Health and Health Disparities

National Instituteon Aging

National Instituteon Aging

National Instituteof Child Health

and HumanDevelopment

National Instituteof Child Health

and HumanDevelopment

National HumanGenome Research

Institute

National HumanGenome Research

Institute

National Instituteof Nursing Research

National Instituteof Nursing Research

National Centerfor Complementary

and AlternativeMedicine

National Centerfor Complementary

and AlternativeMedicine

National Centerfor ResearchResources

National Centerfor ResearchResources

Clinical Center

Clinical Center

National Institute of Biomedical Imaging and Bioengineering

National Institute of Biomedical Imaging and Bioengineering

National Instituteof General

Medical Sciences

National Instituteof General

Medical Sciences

no fundingauthority

27 Institutes and Centers (IC)

Dual Nature of NIH8

NIH Extramural Research~ 90K applications/year~ 45K ongoing awards/year~ 3K institutions> 300K scientists & researchers ~ 83% of the NIH budget

NIH Intramural Research

~ 6K scientists & researchers~ 10% of NIH budget

5

Data: Assoc of University Technology Managers (AUTM) Survey 2004

Alaska

Pre-award: Communication w/Program Staff

CSR assigns to IC, SRG

SRG 1st level of Review

2nd level of Review = Council

Not Fundable

Applicant Evaluates SS

Revised Application (x1)

Prepared

Applicant Notified and Given Feedback

Application to NIH

Summary Statement (SS) to Applicant

NIH NIH Application Application Process Process OverviewOverview

Application to NIH via CSR

IC Makes Award

Award Ends,Renewal Application Prepared

Fundable

Time to Talk w/ NIH Program Officer

Progress Reports

Communication: Means to Funding

Communicate with: NIH staff – esp., PROGRAM OFFICIALS

Your Fellow Investigators

Your Institutional Administrators

12

Applicant Institution

Authorized Institutional

Official

Principal Investigator

Sponsored Research

Administrator

NIH

Review Officer

ProgramOfficer

Grants Management Administrator

TEAMS

Program Official

aka Program Director or Program Officer Both a Scientist and Administrator Responsible for the programmatic,

scientific, and technical aspects of a grant

Program Official Responsibilities

Provide technical assistance to applicants Observe scientific review meetings Discuss review issues with applicants Prepare funding recommendations Manage scientific research/training portfolios Review annual research/training progress of grantees Report scientific progress and program accomplishments Identify opportunities and needs of science specific to an Institute’s

mission Communicate program priorities

- Funding Opportunity Announcements (FOA)- Request for Applications (RFA)

Program Official (PO)

Principal liaison between investigators & NIH

Your most important contact

Contact us early … Contact us often!

How to Meet a Program Officer? Meet PO at Your Favorite Scientific or

Professional Meeting Institute Booths Mingling thru the Crowds Institute sponsored Workshops

Ask your Colleagues Search NIH Institute Websites or Directory View names/contact info on FOAs and RFAs

Why Contact a Program Officer?

To Direct You to:

The appropriate Institute- 24 Institutes have granting authority

The appropriate Division/Office- Basic, clinical, behavioral, translational, training

The appropriate Program Official- Extramural research portfolio

Must I Contact the NIH Before Applying? --- YES!

Mandatory:Application with >$500K budget DC/yearR13 Conference Grants

Optional:When RFAs request a Letter of Intent

Recommended:When you think about applying for ANY grant

Benefits of Making Contact

To develop a relationship with a potential program official

To assure that your application has a home (appropriate Institute)

Developing Your Application

Search NIH RePORT http://projectreporter.nih.gov/reporter.cfm

NIH Guide – FOAs and RFAs http://grants.nih.gov/grants/guide/index.html

Search Institute Web Sites www.nih.gov/icd/

Contact Institute Staff http://ned.nih.gov/

Before You Submit – Talk to PO Organize your thoughts for productive conversation

Grant Purpose: Want a grant from which IC to do what? Problem/Background: Explain why you to think this topic

needs study. Demonstrate you know Institute priorities. Significance: Explain why this is important in the field. Question: What hypotheses will you test and what model will

guide your hypotheses? Design/Analysis: What is the study design that will enable

testing your hypotheses? What statistical approach? Team: Who will be the key participants (co-investigators and

organizations) on the project? Miscellaneous: Other issues that may be relevant

Program Officials…

… are not done after you submit your

application

PO Attends Review Meeting

Observes the review group meeting Is a liaison to Scientific Review Officer

(SRO) (e.g., provide clarification of FOA to the panel, if requested by the SRO)

Is able to answer your questions about the review (especially useful if your application is unscored)

Review Meeting

Review Meeting (or called Study Sections) are managed by NIH personnel called Scientific Review Official who is a PhD-level professional with scientific background close to the expertise of the study section

Each standing study section has 12 - 24 members who are primarily from academia

As many as 60 - 100 applications are reviewed at each study section meeting

After Peer Review Applicants receive a Summary Statement (SS)

Written Account of Essentially Unedited Critiques Overall Resume and Summary of ReviewPriority Score & Percentile RankingBudget Recommendations

Contact PO to inquire about likelihood of funding If you disagree with facts on SS; contact your

Program Official (PO). PO may submit an appeal to Council (2nd level of review)

PO- prepares funding recommendations

What Determines Funding?

Scientific Merit (Review Group)

Program Considerations (Program Official, Advisory Council, IC Director)

Availability of funds

NIGMS

* URM as indicated in FOA. *^ Honors as defined by applicant institution, typically GPA

Impact Scores & Meanings

Consult with program officer on possible next steps

Respond to reviewer concernsRevise application and resubmit

Not Funded?

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Write a clear Introduction section Address all criticisms thoroughly Respond constructively: don’t be

argumentative, abrasive or sarcastic! Acknowledge and accept the help of reviewer

comments

Revise and Resubmit

Post-award: Communication w/Program Staff

Funded, Now What?

Notice of Award (NoA)Legally binding documentAward data and fiscal informationGrant payment infoTerms and conditions of awardGrantee accepts terms and conditions of

award when draw down funds

PO: Grant Oversight

Serve as resource and liaison

Answer technical questions

Monitor progress of study

You Submit Annual Non-competing Renewals

Monitor scientific progress

Confirm policy adherence

Evaluate changes in key personnel or levels of effort

Communicate your exciting results

PO: Grant Oversight – Progress Reports

A clear and concise presentation of major highlights and/or problems encountered and possible resolutions

Summary of your accomplishments Specific aims (as funded) Results (during reporting period) Significance Plans for next budget period

List of publications generated by project Explain any changes in Human Subjects or Vertebrate Animal

Research Report on gender and minority inclusion

Annual Progress Reports

Annual Progress Reports

Due 60 days prior to budget period start date eSNAP - due date is the 15th day of the month

preceding the month in which the current budget period ends

Submit Preferred via NIH eRA Commonshttps://commons.era.nih.gov/commons/index.jsp

or to

Centralized NIH Receipt Point http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-04-063.html

Progress Report Checklist for PO  Program Looks to See :

Is progress satisfactory? (If no, explain.) Add Comment Is there a change in the scope, goals, or objectives of the project? If yes, does this change benefit the project and is it approved? (If

not, explain.) Is there a change in key personnel or their level of effort? (If yes,

describe.) If there are changes/concerns in the Multiple PI leadership plan,

is the new plan acceptable? Is there evidence of scientific overlap? (If yes, explain.) ….. If a progress report for a supplement is required, is progress

reported and acceptable? Are there other issues that should be resolved prior to issuing an

award? (If yes, provide details.) If any issues have not been resolved, should a restricted award

be made?

37

PO: Grant Oversight – Actions Requiring Prior Approval

Change in ScopeSignificant change in aims, methodology,

approach, or other aspects of project objectivesReflects significant change from the project as

reviewed and approvedExamples:

Change in specific aims Change to a different animal model Any change from the approved use of animals

or human subjects Shift of research emphasis to a different

disease area

Desired Change of Grantee InstitutionProgram Official assesses:

If Grant mechanism permits Progress to date Adequacy of new resources and environment Availability of expertise (key personnel) Potential problems (e.g., equipment)

Contact NIH Program Officer early!

PO: Grant Oversight – Actions Requiring Prior Approval

Desired Change in Status of PIChange of PI>25% change in PI effortPI absence of 90 days or more

Note: A project cannot be converted from a single PI to a Multiple PI project during a non-competing phase

PO: Grant Oversight – Actions Requiring Prior Approval

NIH Resource Web Links:

Overview of Electronic Submission http://era.nih.gov/ElectronicReceipt/

Frequently Asked Questions http://era.nih.gov/ElectronicReceipt/faq.htm

Avoiding Common Errors http://era.nih.gov/ElectronicReceipt/avoiding_errors.ht

Office of Extramural Research Grants Home Page: http://grants.nih.gov/grants/oer.htm

PHS2590 Progress Report (form pgs are PDF-fillable): http://grants.nih.gov/grants/funding/2590/2590.htm

Questions?