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.
CSR handles the review process for NIH grant applications

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 Contracts Cooperative Agreement
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.
Project is contracted out.

6. Research Grants. Unsolicited: Solicited
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.
R03: ($50k/year, up to two years, not renewable.
R21 $100k/year, up to 3 years, not renewable.
R33: Non-competing continuation application, Phase II

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.
R03: ($50k/year, up to two years, not renewable.
R21 $100k/year, up to 3 years, not renewable.
R33: Non-competing continuation application, Phase II 12

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.
Institiutions select the trainees

16. Activity codes and Parent Announcements
NIH activity codes (R01, R03, etc..)
Guide for parent proposals

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
Subscribe to newsletters

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)
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).
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

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.

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
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:
Institiutions select the trainees

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.

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
K 25: Quantitative career development, NHLBI
Funded grants:
Institiutions select the trainees

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).
Members of study sections are non-NIH scientific experts, who assess the scientific merit of grant applications.

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 ( 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 Cycle I AIDS/Others Cycle II Cycle III
Submission date
May 7/March 5
September7/June 5
January 7/October 5
Scientific Merit Review
June - July
October - November
February - March
Advisory Council Review
September - October
January - February
May - June
Earliest Project Start Date
December
April
July

36. Important web sites General information NIH
Center for Scientific Review
Tutorial about grant application process at NIAID.

37. Important website contd.
Subscribe to NIAID News letter.
Program contact NIAID, Biostatistics program
Misrak Gezmu,

38. Thank You.