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 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

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: 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 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 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/ A lot of critical information and answers to your questions can be found online . . . .

Center for Scientific Review (CSR)