1. NIH Grant Renewal Review Process (and Beyond)
Cathleen L. Cooper, Ph.D.
Director, CSR Division of Receipt and Referral
NCI New Grantee Workshop
March 15, 2013

2. National Institutes of Health
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
Eunice Kennedy
Shriver 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 Heart,
Lung, and Blood
Institute
National Human
Genome Research
Institute
National Institute
of Mental Health
National Institute
of Neurological
Disorders and
Stroke
National Institute
of Nursing Research
National Institute of
Biomedical Imaging
and Bioengineering
National Center
for Complementary
and Alternative
Medicine
John E. Fogarty
International
Center
National Center
for Advancing
Translational Research
National Library
of Medicine
National Institute on
Minority Health and
Health Disparities
Clinical Center
Center for
Information
Technology
Center for
Scientific Review

3. Submitting Your Renewal Application

4. Review Assignment for Your Renewal R01 Application
Default: same study section where your funded grant was reviewed, unless:
Study section no longer exists
Submit to a Funding Opportunity Announcement (FOA) with special review arrangements
Study section member now named in your renewal application
Your science has moved in a new direction and no longer fits
Cover letter request for different study section (if appropriate)

5. Sample Cover Letter
Please assign this Phase I SBIR “Drugs for Retinoblastoma Treatment” (RFA-CS ) to the following: Institutes/Centers National Cancer Institute National Eye Institute Scientific Review Group Oncology Translational and Clinical IRG Please do not assign this application to the following: Biological Chemistry and Macromolecular Biophysics This study focuses on a new in vitro model for testing drugs for treatment of retinoblastoma, not the synthesis of new chemotherapeutic agents.

6. Reviewing Your Renewal R01 Application – Part 1
Review includes:
Copy of your application as submitted, including progress report section of Research Strategy
Copy of summary statement for the funded grant
Critique:
Renewals – “the committee will consider the progress made in the last funding period.”
Resubmitted Renewals – the committee will consider progress AND “evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.”

7. Reviewing Your Renewal R01 Application – Part 2
Review does NOT include:
Notice of Grant Award (NGA)
Progress Reports from non-competing years
Previous grant application
New/Early Stage Investigator (NI/ESI) consideration
Reviewers who reviewed your funded grant (probably not)

8. Do I have to Submit my Renewal as a Renewal?
You can submit your renewal as new BUT:
You are unable to include a progress report.
Your application may be withdrawn if aims are too similar to funded grant.
Your subsequent renewal application, if any, will be blocked if aims of that application are too similar to this new one.

9. The Problem: My A1 is not funded, what do I do?
Talk to your Program Director!
Option #1: Keep the Science and find a new way to submit it (e.g., change activity code, submit to RFA)
Option #2: Change the Science and submit a new application using the same activity code (e.g., R01 -> R01)
Option #3: Wait 37 months since the first (A0) submission and submit as new (NOT-OD ).

10. Option #1: Apply for a Different Type of Grant
There is no limit to the amount of overlap is you apply for a different type of grant once you have your summary statement from the last review in hand.
Example 1
Change Activity Code
Take a strong aim/aims from your R01 and submit as an R21
Submit your R01 aims for another similar-sized grant, such as a P01 or U01 (relevant FOA required).

11. Some Key Definitions:
Activity Code (three character codes used to differentiate the wide variety of research related programs supported by NIH. Examples: R01, R21, R03, etc.)
Funding Opportunity Announcements (FOA) include both RFAs and Program Announcements
RFA (Request for Applications) will be numbered like this: RFA-CA
Program Announcements (PA/PAR/PAS) will be numbered like this: PA , PAR , etc.

12. Option 1: Apply for a Different Kind of Grant
There is no limit to the amount of overlap is you apply for a different type of grant once you have your summary statement from the last review in hand.
Example 2
Change Activity Code
Take a strong aim/aims from your R01 and submit as an R21
Submit your R01 aims as a U01
Submit your R01 to a new R01 RFA.

13. Option #2: Change the Science
NIH will not accept similar grant applications with essentially the same research focus.
This policy applies to all NIH funding activities.
The same criteria are used to evaluate overlap of new vs. funded, new vs. resubmission, and concurrently submitted applications.
Non-compliant applications identified by NIH at any stage of the process (referral, peer review, program/grants management) will be withdrawn.
See NIH Guide: NOT-OD

14. A New Application… Is substantially different in content and scope
Has more significant differences than are normally encountered in a resubmitted application
Includes substantial changes, particularly in the Specific Aims and the Research Strategy sections
Has fundamental changes in the questions being asked and/or the outcomes being examined
Includes changes to the Research Plan that should produce a significant change in direction and approach for the research project outcomes examined
See NIH Guide NOT-OD

15. Is My New Application New Enough?
Compare your A1 and draft of your new application. Ask:
Are the differences in my new application consistent with a resubmission—did I write it as the A2 resubmission of an old application?
Are many/most/all of the changes responsive to weaknesses identified in the previous critiques?
Are most of the research questions posed in the old application also in the new one?
Are the majority of outcomes expected in the old research plan also found in the new one?

16. How Do I Expand My Research Funding?
Scenario 1: My R01 research really took off and now I have enough data to support 2 R01 applications!
Submit one as new and one as your renewal so long as the aims do not overlap. Consult your Program Director!
Scenario 2: I am making good progress and I would like to apply for an additional grant to fund a new direction.
Submit your R01 renewal and think about applying for a small grant award, like R03 or R21, so long as the aims do not overlap.

17. How NOT to Submit a Late Application
START EARLY
On time application = submitted, error-free, by 5 PM local time on due date
Application must be accepted TWICE: Grants.gov and NIH
Errors cause rejection; Warnings are error free and accepted
Check eRA Commons for your submitted application
( s are sent but can be caught in SPAM filters)
High volume at deadlines slows processing/validation time
Corrected application submitted after deadline is late

18. Early Career Reviewer (ECR) Program
Train and educate qualified scientists without significant prior review experience so that they may develop into critical and well trained reviewers
Help emerging researchers advance their careers by exposing them to review experience that may make them more competitive as applicants
Enrich the existing pool of NIH reviewers by recruiting scientists from less research-intensive institutions as well as those from traditionally research-intensive institutions.
Information available at

19. Requirements for Being an ECR Responsibilities of an ECR
Full-time faculty member or researcher
An active independent research program
At least 2 recent senior authored research publications
Has not yet been a reviewer at CSR
Prior research funding not required
Participate in reviewer training
Review 2 to 4 grant applications and provide written critiques
Attend study section meeting
Participates in no more than one study section per year and no more than twice total
Information available at

20. Key NIH Review and Grants Web Sites
NIH Center for Scientific Review
NIH Office of Extramural Research
A lot of critical information and answers to your questions can be found online

21. Center for Scientific Review (CSR)