NIH Mentored Career Development Awards (K Series) Part 5

1. NIH Mentored Career Development Awards (K Series) Part 5 Thomas Mitchell, MPH Department of Epidemiology & Biostatistics University of California San Francisco

2. What happens to your grant application after it is submitted to NIH? • All grant applications are reviewed, initially, in the Center for Scientific Review (CSR). • Referral officers (all of whom have advanced degrees) examine applications and decide whether they will be reviewed by a study section within the CSR or will be assigned directly to an NIH institute, which will assign it to one of their “in-house” study sections. • Grant applications for K awards, responses to RFAs, and program project grants are reviewed within the Institute (e.g., NHBLI, NCI, NIAID).

3. What happens to your grant application after it is submitted to NIH? • Investigator-initiated research projects (R01, R03, R21) are reviewed within the CSR. • They are assigned to an “integrated review group”, which are clusters of study sections that review similar science. • For the majority of applications, these review groups are categorized into 3 main areas: • Molecular and Cellular Mechanisms • Clinical and Population-based Studies • Physiological Systems.

4. What happens to your grant application after it is submitted to NIH? • Each of these main areas is split into different IRGs, which are further divided into numerous study sections. • Once the IRG is identified, the application is assigned to one of the constituent study sections. • Referral officers also must choose, from NIH’s 25 institutes and centers, the one most appropriate to fund an application.

5. What happens to your grant application after it is submitted to NIH? • You can request assignment to a specific study section and institute (see Examples 1 and 2). • Within 10 days of the completion of application assignment (which may be up to 6 weeks after the application is received at NIH), a notice will appear in your NIH eRA Commons file listing the study section and potential funding institute. • Upon receipt of this notice, applicants can question the study section or institute assignments by contacting either the study section SRA or the Referral Officer.

6. After assignment to a study section • The SRA who heads the study section reads all applications, analyzes content, checks for completion, and decides which reviewers are most suitable to review an application and whether there are conflicts of interest between reviewers and applicants. • Applications are sent to reviewers 6 – 8 weeks before they meet. Each application has one primary reviewer, one or more secondary reviewers, and one or more discussants.

7. After assignment to a study section • At the beginning of the study section meeting, reviewers are asked to identify those applications with the highest scientific merit. • Those applications are discussed and scored. • Applications not so identified are “streamlined.” • They are not scored or discussed at the meeting, but reviewers’ written critiques are provided to the applicant, and the applicant may subsequently revise and resubmit the application. • Applications from “early stage investigators” (ESIs) are reviewed before other applications from more senior investigators. • “Early stage investigators” are within 10 years of their terminal degree and have not yet competed successfully for an R01. • Many NIH institutes have a higher (more favorable) payline for R01 applications from ESIs.

8. At the study section meeting • Study section meetings usually last 2 days. • The chairperson and the SRA jointly conduct the meeting. • Representatives from various NIH institutes are encouraged to attend but must sit in chairs set back from the conference table and may not participate in the discussions. • The chair, who is also a reviewer, asks the primary and secondary reviewers to tell the study section how enthusiastic they feel about an application.

9. At the study section meeting • They then proceed to summarize their reviews (they usually give an initial rating or score). • After discussion, which potentially involves the entire study section, they may change their rating (for better or worse) and state their final priority score. • From either their own analysis or the discussion, the other study section members privately score the application on their vote sheets, which the SRA collects at the end of the meeting. • One week after the meeting, priority score information is sent to the applicant’s eRA Commons file.

10. NIH Scoring Procedures • Numerical rating • Each scored grant application is assigned a single, global score that reflects the overall impact that the project could have on the field, based on the 5 review criteria (significance, approach, innovation, investigator, and environment). • Reviewers will use a new 9-point rating scale. 1 = exceptional; 9 = poor. • Individual reviewers mark scores to two significant figures (e.g., 2.2); individual scores are averaged and multiplied by 100 to give an overall score for each application (e.g., 220).

11. NIH Scoring Procedures • Percentile conversion • Research grant applications (e.g., R01s, R03s, R21s) are assigned a percentile rank. • The conversion of priority scores to percentile rankings is based on scores assigned to applications reviewed during the current plus the 2 previous grant cycles. • K awards do not receive a percentile ranking.

12. Summary Statements(the “pink sheets”) • Primary and secondary reviewers are asked to modify their critiques during the study section meeting (removing, for example, criticisms that are negated through discussion among reviewers). • Otherwise, the reviewers’ critiques are included in the summary statement, essentially unaltered by the SRA. • Additionally, the SRA prepares a “Resume and Summary of Discussion” that conveys the highlights (major strengths and weaknesses) of the discussion that led to the final score. • Summary statements are sent to applicants 6 to 8 weeks after the study section review.

13. To Fund or Not to Fund? • Members of the institute’s advisory council meet 3 times a year to decide which applications to fund. • Council members do not provide a scientific/technical review of individual applications; however, they do consider which applications best meet the institute’s overall mission and funding priorities.

14. To Fund or Not to Fund? • The institute’s director and other staff members reach their final decisions after considering both the opinions of its advisory council and the study section review statements. • “Payline”: Each institute sets its own payline, which is the numeric or percentile “cut-off” for funding.

15. To Fund or Not to Fund? • Funding considerations • New investigators get bumped up in ranking. • An institute may decide to fund a project that is highly relevant to an institute’s priorities, even if the priority score and percentile is above the payline.

16. Resubmissions • If you are not funded on the 1st round, you can resubmit your application once. • Must use same title as initial application. • Many grant applications that are not funded on the 1st round are subsequently funded as resubmissions. • If the scientific goals, methods, or scope of the research project changes substantially, it could be considered as a new submission

17. Resubmissions • 3-page introduction to resubmission • Must address each reviewer’s criticisms. • Based on these 3 pages, your resubmission must be viewed by reviewers as fully responsive to their concerns if you are to get a fundable score. • You’ve addressed all their issues. • They’re satisfied with all your responses. • No issues remain unresolved. • See Examples 3, 4, 5, and 6.