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

National Institutes of Health

National Instituteon Alcohol Abuseand Alcoholism

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis and

Musculoskeletaland Skin Diseases

National Instituteof Arthritis and

Musculoskeletaland Skin Diseases

National CancerInstitute

National CancerInstitute

National Instituteon Drug Abuse

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

National Instituteof Environmental Health Sciences

National Instituteon Aging

National Instituteon Aging

Eunice KennedyShriver National Institute

of Child Health andHuman Development

Eunice KennedyShriver National Institute

of Child Health andHuman Development

National Institute onDeafness and Other

CommunicationDisorders

National Institute onDeafness and Other

CommunicationDisorders

National EyeInstitute

National EyeInstitute

National HumanGenome Research

Institute

National HumanGenome Research

Institute

National Instituteof Mental Health

National Instituteof Mental Health

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof General

Medical Sciences

National Instituteof General

Medical Sciences

National Instituteof Nursing Research

National Instituteof Nursing Research

National Libraryof Medicine

National Libraryof Medicine

Center for Scientific Review

Center for Scientific Review

National Centerfor Complementary

and AlternativeMedicine

National Centerfor Complementary

and AlternativeMedicine

National Instituteof Allergy and

Infectious Diseases

National Instituteof Allergy and

Infectious Diseases

John E. FogartyInternational

Center

John E. FogartyInternational

Center

National Centerfor Advancing

Translational Research

National Centerfor Advancing

Translational Research

Clinical Center

Clinical Center

National Institute on Minority Health andHealth Disparities

National Institute on Minority Health andHealth Disparities

National Institute of Biomedical Imagingand Bioengineering

National Institute of Biomedical Imagingand Bioengineering

Office of the DirectorOffice of the Director

Center for InformationTechnology

Center for InformationTechnology

National Heart,Lung, and Blood

Institute

National Heart,Lung, and Blood

Institute

National Instituteof Dental andCraniofacial

Research

National Instituteof Dental andCraniofacial

Research

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Diabetes andDigestive and

Kidney Diseases

Submitting Your Renewal Application

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)

Sample Cover Letter

Please assign this Phase I SBIR “Drugs for Retinoblastoma Treatment” (RFA-CS-00-000) 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:

Scientific Review Group

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.

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.”

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)

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.

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-10-140).

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).

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-12-022− Program Announcements (PA/PAR/PAS) will be numbered

like this: PA-11-260, PAR-09-162, etc.

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.

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-09-100

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-10-080

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?

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.

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

(e-mails are sent but can be caught in SPAM filters)

• High volume at deadlines slows processing/validation time• Corrected application submitted after deadline is late

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 www.csr.nih.gov/ECR

Requirements for Being 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

Responsibilities of an ECR

• 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 www.csr.nih.gov/ECR

Key NIH Review and Grants Web Sites

NIH Center for Scientific Review

http://www.csr.nih.gov

NIH Office of Extramural Research

http://grants.nih.gov/

Center for Scientific Review (CSR)