NIH Grant Mechanisms and Funding Process

1. NIH Grant Mechanisms and Funding Process Misrak Gezmu, Ph.D. NIH, NIAID ASA Caucus of Academic representatives For Chairs of Programs in Statistics/ Biostatistics August 1, 2009 ASA, Alexandria, VA

2. Outline • Overview of NIH extramural activities. • NIH Funding mechanisms and Activity codes. • Funding Opportunity Announcements. • New Investigators • Application submission and where to get help • Review and Funding process. • Contact information.

3. National Institute of Health (NIH) • 27 institutes and centers • Most institutes are disease specific. • Eg. National Institute of Allergy and Infectious Diseases (NIAID), National Cancer Institute (NCI). • Each institute has different programs, Eg. Statistical methods research for infectious diseases at NIAID. • National Institute of General Medical Sciences (NIGMS). General Biomedical Research. • Center for Scientific Review.

4. NIH Extramural activity • NIH funds the best scientific research projects to improve the public health. • Approximately 80% of NIH’s budget is allocated for funding research projects. • The merit of each application is reviewed by NIH’s peer review system

5. Funding mechanisms • Grants • Investigator(s) responsible for developing the concepts, methods, and approach for a research project. • Contracts • The Institute is responsible for establishing the detailed requirements. • Cooperative Agreement • Both the awarding unit and the recipient have substantial responsibility.

6. Research Grants. • Unsolicited: • Principal Investigator initiated. The researcher works in the research interest of an Institute. • Solicited • Request for Application (RFA): • Initiative sponsored by one or more Institutes requesting application in a well defined area. • Program Announcement (PA): • Announcement in stated scientific area, one or more ICs.

7. NIH Extramural Activity Codes • Fellowship programs (F). • Research career programs (K). • Research program projects and centers (P). • Research projects (R). • Training programs (T) • Cooperative agreement (U)

8. Fellowship Programs (F) • Provides individual grants to students and scientists to develop careers in biomedical research. • F31: provides supervised individual predoctoral fellowship to promote diversity. • F32: provides postdoctoral research training to broaden background or extend research. • F33: provide opportunities for experienced scientists to take time from regular duties and to engage in health- related research.

9. Research Career Programs (K). • Biomedical research career development. • K01: Mentored research scientist development award. • K07: Academic career award. Develop research expertise and to improve the curricula and enhance the research capacity. • K25: Mentored quantitative research career development award. Supports investigators with quantitative background to focus on biomedical research.

10. Research Program Projects and Centers (P). • P01: Research Program Project. • Provides an institution with support for a multidisciplinary, long-term research program with an objective or theme involving groups of investigators. • P30: Center Core Grants • Support shared resources and facilities for a multidisciplinary research team or a group of investigators focusing on a common research topic.

11. Research Project • R01: Discrete, specified project to be performed by the Principal Investigator. • R03: Provides support for preliminary short-term projects in response to RFA,PA. • R13: Provide funding for conferences to exchange and disseminate information related to program interests.

12. Research Project Contd. R15:Academic Research Enhancement Award. To support research projects from institutions that have not been major recipients of NIH research grant funds R21 Exploratory/Developmental Grants, submitted in response to RFA, PA . R21/R33(new): phase/phase II for research begun as an R21 award.

13. R34/U01(Clinical Trial)Planning /implementation • R34 (new): support initial development of clinical trial. • eg. Establish research team, developing tools for managing data and overseeing the research, developing trial designs, recruitment strategies, and procedure manuals. • Successful R34 can apply for Cooperative agreement. • U01 clinical trial implementation

14. Small Business Grants • R41(phase I)/R42 (phase II): Small Business Technology Transfer (STTR). • Support cooperative research projects between small business and research institutions. To Establish merit and feasibility ideas with potential for commercialization. • R43 (phase I)/R44 (phase II): Small Business Innovation Research (SBIR). • Support projects to establish technical merit and feasibility which lead to commercial products and services

15. Training programs (T) • T15: Short courses. • T32: fund academic institutions for training pre-doctoral and postdoctoral candidates. • T35: provide research training during off-quarters or summer periods.

16. Activity codes and Parent Announcements • NIH activity codes (R01, R03, etc..) • http://grants.nih.gov/grants/funding/funding_program.htm • Guide for parent proposals • http://grants.nih.gov/grants/guide/parent_announcements.htm

17. Check ICs requirement for activity codes • NIH Institutes and Centers (ICs) may vary in the way they use activity codes; look closely at Funding Opportunity Announcement (FAOS) to determine which ICs participate and the specifics of eligibility. • Funding Opportunity and notices weekly • http://grants.nih.gov/grants/guide/index.html • Subscribe to newsletters • http://www.niaid.nih.gov/ncn/newsletters/default_subscribe.htm

18. Examples of Funding Opportunity Announcements relevant to statisticians. • R25: Education projects • PA: Short Courses on Mathematical, Statistical, and Computational Tools for Studying Biological Systems (NIGMS and other ICs) • http://grants.nih.gov/grants/guide/pa-files/PA-09-002.html • Eg. 3 weeks summer Institute in statistics and modeling of infectious diseases training (University of Washington).

19. Examples of FAOs relevant to statisticians contd… • T15: Short term courses • The Summer Institute for Training in Biostatistics I and II (NHLBI and NCRR). • http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-09-009.html • Eg. A comprehensive six-week summer training course on. Designed to address a growing imbalance between the demand and supply for biostatisticians. (Boston University, NC State, University of Wisconsin)

20. Examples of FAOs relevant to statisticians contd… (this week) R01, R21: Research project, Exploratory Research to advance vaccine safety: creation/evaluation of statistical methodologies for analyzing data on vaccine safety, including data available from existing data sources such as passive reporting systems http://grants.nih.gov/grants/guide/notice-files/NOT-AI-09-050.html

21. New Investigator (NI) and Early Stage Investigators (ESI) • NI: Has not previously received a significant award from NIH (R01, Challenge grant etc.) • ESI: With in 10 years of completion of terminal degree. • Has special payline for R01s • NIAID 2008: 12% R01 vs 16% *R01 • NIH website for Nis and ESIs. • http://grants.nih.gov/grants/new_investigators/

22. NIH Pathway to Independence (K99/R00) award • Must be within 5 years of terminal degree. • Phase I: mentored support, 1-2 years fellowship (K99). • Phase II: Independent research (R00). • Work towards preparing an R01 application

23. Application submission • NIH website on grants process is a useful resource • http://www.grants.nih.gov/grants/grants_process.htm • Submit electronically through Grants.gov using the SF424 (R&R) application • You also must register with the eRA Commons(your institution must do this for you). • eRA Commons: NIH Electronic Research Administration website: https://commons.era.nih.gov/commons/

24. Where to get help? • Center for Scientific Review. • Questions about application process and study section assignment. • Questions about the merit review process: Scientific Review Officer. • http://cms.csr.nih.gov/

25. Where to get help? Contd… • Program Contact: Program Officer(Visit institute website to find contact person) • Gives advice on research interest of the program to researchers before application is submitted. • Attends grant peer reviews. • Sends cover letter with the summary statement from the review.

26. Examples of sample proposals and funded grant abstracts. • R01: Research project proposals, NIAID • http://www.niaid.nih.gov/ncn/grants/app/default.htm • K 25: Quantitative career development, NHLBI • http://www.nhlbi.nih.gov/funding/training/redbook/k25models.htm • Funded grants: • http://crisp.cit.nih.gov/

27. Selected Statistical Topics from NIAID Statistical Methods Portfolio • Mathematical and experimental models for HIV dynamics. • Stat methods for evaluating vaccine efficacy. • Data-driven computational modeling of the growth and spread of viruses • Nonparametric modeling of long-term HIV/Cell dynamics.

28. Review of grant applications (R01) Eg. NIAID statistical methods. • NIH Center for Scientific Review (CSR) • Receives applications and gives ID number. • Assigns each application to • An NIH Institute through the referral guide line • One of the integrated review groups (IRG), study sections (for scientific merit review).

29. Study sections relevant to Statisticians • Biostatistical Methods and Research Design (BMRD) • AIDS Clinical Studies and Epidemiology (ACE; statistical methods relevant to HIV research) • Modeling and Analysis of Biological Systems (MABS; modeling complex biological systems)

30. 1st Level Peer Review, Scientific Merit(Study Section Responsibilities) • ~ 20 independent reviewers in each study sections. (Each application will have 3/4 reviewers). • Actions • Approval: Sufficient merit to be worthy of support and will receive priority score (1.0 - 9.0 with 1 being the best). • Disapproval: No sufficient merit, no priority score. • Deferral: Cannot make recommendation without additional information.

31. Most common Reasons for proposal to be not-highly-meritorious • Lack of new or original ideas, • Unfocused Research Plan, • Lack of experience in the biology/methodology, • Lack of knowledge of Published relevant work, • Uncertainty concerning the future directions, • Unrealistically large amount of work, • Lack of experience/expertise in the biology*, • Not readable to clinicians*. • *common reasons on statistical methods grants.

32. Pay Line • Depending on the budget, a pay line will be determined for each of the institutes. • NIAID 2008 FY pay line (percentile or score). • R01:12 %; 16% for new investigators • F31: 144, K: 154, R41/R42: 187

33. National Advisory Council(Second level-Peer Review, Funding Recommendation) • National Advisory Allergy and Infectious Disease Council. • Diverse group that performs several key functions for the institute. • Council members consist of Scientific experts, Division Directors and Advocacy organization representatives. • Makes funding recommendations to NIAID Director based on program priorities and policy issues.

34. What determines which awards are funded? • Scientific Merit (Study section result). • Program and/or Policy considerations • Availability of funds

35. Important dates for R01

36. Important web sites • General information NIH • http://www.nih.gov/index.html • Center for Scientific Review • http://cms.csr.nih.gov/ • Tutorial about grant application process at NIAID. • http://www.niaid.nih.gov/ncn/grants/default.htm

37. Important website contd. • Subscribe to NIAID News letter. • http://www.niaid.nih.gov/ncn/newsletters/default_subscribe.htm • Program contact NIAID, Biostatistics program • Misrak Gezmu, mgezmu@niaid.nih.gov

38. Thank You.