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

2. OUTLINE NIH Overview Pre-award: Communication w/ Program Staff
Post-award: Communication w/ Program Staff

3. NIH Overview

4. “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

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

6. National Institutes of Health
NIGMS
National Institutes of Health
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
Intramural Research
R&D
Contracts
Research
Centers
Other Research
All Other
Training
Mgmt & Support 3% 5% 6%
Research Project
Grants (RPG)
53%
10%
11%
Annual Budget
~$31 Billion
Fiscal Year 2013

7. 27 Institutes and Centers (IC)
NIGMS
27 Institutes and Centers (IC)
Office of the Director
National Library
of Medicine
Center for
Information
Technology
Scientific Review
Fogarty
International
Center
National Institute
of Arthritis and
Musculoskeletal
and Skin Diseases
of Diabetes and
Digestive and
Kidney Diseases
of Dental and
Craniofacial
Research
National Institute on
Deafness and Other
Communication
Disorders
National Eye
Institute
National Heart,
Lung, and Blood
on Alcohol Abuse
and Alcoholism
National Cancer
on Drug Abuse
of Environmental
Health Sciences
of Mental Health
of Neurological
Disorders and
Stroke
of Allergy and
Infectious Diseases
National Center on
Minority Health and
Health Disparities
on Aging
of Child Health
and Human
Development
National Human
Genome Research
of Nursing Research
National Center
for Complementary
and Alternative
Medicine
for Research
Resources
Clinical Center
National Institute of
Biomedical Imaging
and Bioengineering
of General
Medical Sciences
no funding
authority

8. NIH Extramural Research
Dual Nature of NIH 8
NIH Extramural Research
NIH Intramural Research
~ 6K scientists & researchers
~ 10% of NIH budget
~ 90K applications/year
~ 45K ongoing awards/year
~ 3K institutions
> 300K scientists & researchers
~ 83% of the NIH budget

9. Pre-award: Communication w/Program Staff

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

11. Communication: Means to Funding
Communicate with:
NIH staff – esp., PROGRAM OFFICIALS
Your Fellow Investigators
Your Institutional Administrators

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

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

14. 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)

15. Program Official (PO) Principal liaison between investigators & NIH
Your most important contact
Contact us early …
Contact us often!

16. 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

17. 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

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

19. Benefits of Making Contact
To develop a relationship with a potential program official
To assure that your application has a home (appropriate Institute)

20. Developing Your Application
Search NIH RePORT
NIH Guide – FOAs and RFAs
Search Institute Web Sites
Contact Institute Staff

21. 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

22. … are not done after you submit your application
Program Officials…
… are not done after you submit your application

23. 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)

24. 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 members who are primarily from academia
As many as applications are reviewed at each study section meeting

25. After Peer Review 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 (2nd level of review)
PO- prepares funding recommendations

26. What Determines Funding?
Scientific Merit (Review Group)
Program Considerations
(Program Official, Advisory Council, IC Director)
Availability of funds

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

28. Not Funded? Consult with program officer on possible next steps
Respond to reviewer concerns
Revise application and resubmit

29. Revise 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

30. Post-award: Communication w/Program Staff

31. Funded, Now What? 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

32. PO: Grant Oversight Serve as resource and liaison
Answer technical questions
Monitor progress of study

33. PO: Grant Oversight – Progress Reports
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

34. Annual Progress Reports
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

35. 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 Commons
or to
Centralized NIH Receipt Point

36. 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 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

38. PO: Grant Oversight – Actions Requiring Prior Approval
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!

39. PO: Grant Oversight – Actions Requiring Prior Approval
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

40. NIH Resource Web Links:
Overview of Electronic Submission
Frequently Asked Questions
Avoiding Common Errors
Office of Extramural Research Grants Home Page:
PHS2590 Progress Report (form pgs are PDF-fillable):

41. Questions?