Working with NIH Program Officials:
Pre-Award & Post-Award
Shawn Gaillard, NIGMS and
Francisco Sy, NIMHD
2013 NIH Regional Seminar, Baltimore, MD

 NIH Overview
 Pre-award: Communication w/ Program Staff
 Post-award: Communication w/ Program Staff

“ 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

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Secretary of
Health and
Human Services
Administration for
Children and Families
(ACF)
Administration on
Aging
(AoA)
Food and Drug
Administration
(FDA)
Health Resources and Services
Administration
(HRSA)
Center for Medicare
& Medicaid
Services
(CMS)
Agency for
Healthcare Research and Quality
(AHRQ)
Centers for
Disease Control and Prevention
(CDC)
Agency for Toxic
Substances and
Disease Registry
(ATSDR)
Indian Health
Services
(IHS)
National Institutes of Health
(NIH)
Substance Abuse and
Mental Health Services
Administration
(SAMHSA)

NIGMS
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 investigators
 Communicating medical information to public
Annual Budget
~$31 Billion
Fiscal Year 2013
All Other
Training
Mgmt & Support
3%
3%
5%
Other Research
6%
Research
Project
Grants (RPG)
53%
Research
Centers
10%
11%
11%
R&D
Contracts
Intramural Research

NIGMS
Office of the Director
National Institute on Aging
National Institute on Alcohol Abuse and Alcoholism
National Institute of Allergy and
Infectious Diseases
National Institute of Arthritis and
Musculoskeletal and Skin Diseases
National Cancer
Institute
National Institute of Child Health and Human
Development
National Institute on
Deafness and Other
Communication
Disorders
National Institute of Dental and
Craniofacial
Research
National Institute of Diabetes and
Digestive and
Kidney Diseases
National Institute on Drug Abuse
National Institute of Environmental
Health Sciences
National Eye
Institute
National Institute of General
Medical Sciences
National Center for Complementary and Alternative
Medicine
National Heart,
Lung, and Blood
Institute
Fogarty
International
Center
National Human
Genome Research
Institute
National Institute of Mental Health
National Institute of Neurological
Disorders and
Stroke
National Institute of Nursing Research
Clinical Center
National Center for Research
Resources
Center for
Information
Technology
National Library of Medicine
National Institute of
Biomedical Imaging and Bioengineering
National Center on
Minority Health and
Health Disparities
Center for
Scientific Review no funding authority

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NIH Intramural Research
~ 6K scientists & researchers
~ 10% of NIH budget
Alaska
5
Data: Assoc of University Technology Managers (AUTM) Survey 2004
NIH Extramural Research
~ 90K applications/year
~ 45K ongoing awards/year
~ 3K institutions
> 300K scientists & researchers
~ 83% of the NIH budget

NIH
Application
Process
Overview
Application to NIH
Application to NIH via CSR
CSR assigns to IC, SRG
SRG 1 st level of
Review
Summary
Statement (SS) to Applicant
2 nd level of Review
= Council
Fundable
IC Makes Award
Applicant
Notified and
Given Feedback
Progress Reports
Award Ends,
Renewal Application
Prepared
Not
Fundable
Applicant
Evaluates SS
Revised
Application (x1)
Prepared
Time to Talk w/ NIH Program Officer

 Communicate with:
 NIH staff – esp., PROGRAM OFFICIALS
 Your Fellow Investigators
 Your Institutional Administrators

Review
Officer
NIH
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Program
Officer
Applicant
Institution
Principal
Investigator
Authorized
Institutional
Official
Grants
Management
Administrator
Sponsored
Research
Administrator

 aka Program Director or Program Officer
 Both a Scientist and Administrator
 Responsible for the programmatic, scientific, and technical aspects of a grant



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



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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)

 Principal liaison between investigators & NIH
 Your most important contact
Contact us early …
Contact us often!

 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

 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

 Mandatory:
 Application with >$500K budget DC/year
 R13 Conference Grants
 Optional:
 When RFAs request a Letter of Intent
 Recommended:
 When you think about applying for ANY grant

 To develop a relationship with a potential program official
 To assure that your application has a home (appropriate Institute)

 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/

Organize your thoughts for productive conversation

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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

 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 (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


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Applicants receive a Summary Statement (SS)
 Written Account of Essentially Unedited Critiques
 Overall Resume and Summary of Review
 Priority Score & Percentile Ranking
 Budget 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 (2 nd level of review)
PO- prepares funding recommendations


(Review Group)

(Program Official, Advisory Council, IC Director)


Impact Scores & Meanings
NIGMS
Score Descriptor Additional Guidance on Strengths/Weaknesses
40
50
60
70
10
20
30
Exceptional
Outstanding
Excellent
Very Good
Good
Satisfactory
Fair
Exceptionally strong , essentially no weaknesses
Extremely strong with negligible weaknesses
Very strong with only some minor weaknesses
Strong but with numerous minor weaknesses
Strong but with at least one moderate weakness
Some strengths but some moderate weaknesses
Some strengths, at least one major weakness
80 Marginal A few strengths and a few major weaknesses
* URM as indicated in FOA. *^ Honors as defined by applicant institution, typically GPA
90 Poor Very few strengths, numerous major weaknesses


Consult with program officer on possible next steps

Respond to reviewer concerns

Revise application and resubmit

 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
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 Notice of Award (NoA)
 Legally binding document
 Award data and fiscal information
 Grant payment info
 Terms and conditions of award
 Grantee accepts terms and conditions of award when draw down funds

 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

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

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 Commons https://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 :

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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.)
…..
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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?

 Change in Scope
 Significant change in aims, methodology,

 approach, or other aspects of project objectives
Reflects significant change from the project as reviewed and approved
Examples:
 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
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 Desired Change of Grantee Institution
 Program 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!

 Desired Change in Status of PI
 Change of PI
 > 25% change in PI effort
 PI 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


Overview of Electronic Submission http://era.nih.gov/ElectronicReceipt/
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Frequently Asked Questions http://era.nih.gov/ElectronicReceipt/faq.htm

Avoiding Common Errors http://era.nih.gov/ElectronicReceipt/avoiding_errors.ht
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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?