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. Human Subjects Research • A part of the peer review process will include careful consideration of protections from research risks for study participants, as well as the appropriate inclusion of women, minorities, and children (see Example 1). • The study section will assess the adequacy of the safeguards of the rights and welfare of research participants and the appropriate inclusion of women, minorities, and children. • Evaluation of the inclusion plans will be factored into the overall score for scientific and technical merit.

3. Budget Issues • Mentored K awards provide salary support for the candidate (usually $75,000/year) plus $25,000 to $50,000/year to cover the costs of the proposed training and research. • The amount of salary support and funds for research/training may differ by institute. • You may not receive salary support from federally funded sources in Years 1 – 3 of the K award, although you may be a principal investigator on your own R01, R03, or R21 in Years 4 and 5.

4. Budget Issues (cont’d) • A detailed, itemized budget is not required by NIH; however, you are required to provide a detailed description and justification for specific items in the budget. • See Example 2. • Although an itemized, detailed budget is not required by NIH, it is required for internal review by UCSF (but not submitted to the NIH)

5. Biosketches • This section must include the biographical sketches of all Key Personnel and Other Significant Contributors. • All biosketches must include a “Personal Statement” • See Example 3. • The section on publications should be limited to 15 (include only the most relevant, recent, and important) • For the candidate only, the section on Publications must be divided into the following categories: • Original research • Non-experimental articles (e.g., literature reviews, book chapters) • Books, pamphlets, etc.

6. Facilities and Other ResourcesEquipment • Describe the facilities and Other Resources used to conduct the research. • Describe capacities, pertinent capabilities, relative proximity, and extent of availability to the project. • If research involving “Special Agents” will occur, the biocontainment resources available at each site should be described. • See Example 4

7. Abstract & Project Narrative • The Abstract is limited to 30 lines of text (size 11 font, .5” margins). • The Abstract should describe both the career development plan and the research plan. • The Project Narrative should be only 2 or 3 sentences long; it should explain the relevance of the proposed research to public health. • See Example 5.

8. Cover Letter • You must include a cover letter with your K award application. • It should request assignment to a specific institute. • It must also list the names, department affiliation, and institution of 3-5 referees submitting letters of reference (see Example 6). • Letters of reference are critically important and should address the candidate’s competence and potential to develop into an independent investigator. • Letters of reference must be submitted electronically by the referee through the eRA Commons.

9. Task List • Develop a list of all components of your grant application package, including those required by the UCSF Office of Sponsored Research (OSR). • See Example 7. • Indicate who is responsible for completing each component. • Develop this list in collaboration with your RSA (research support analyst), who will help you compile the grant application for submission to the OSR and NIH.

10. 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).

11. What happens to your grant application after it is submitted to NIH? • 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.

12. At the Study Section Meeting • As part of the initial scientific merit review process, reviewers are asked to identify those applications with the “highest scientific merit”. • At the meeting, 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.

13. 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.

14. 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.

15. 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 (signficance, approach, innovation, investigator, and environment). • Reviewers will use a new 9-point rating scale. 1 = exceptional; 9 = poor. • Individual reviewers mark scores in whole figures (e.g., 2, 4, 6), and the individual scores are averaged and then multiplied by 10 to give an overall score for each application (e.g., 22).

16. 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.

17. 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.

18. 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. • Your priority score will appear in your eRA Commons file within a week of the study section meeting.