Nih grant mechanisms and funding process
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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. Outline. Overview of NIH extramural activities.

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NIH Grant Mechanisms and Funding Process

Misrak Gezmu, Ph.D.


ASA Caucus of Academic representatives

For Chairs of Programs in Statistics/ Biostatistics

August 1, 2009

ASA, Alexandria, VA


  • 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.

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.

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

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.

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.

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)

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.

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.

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.

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.

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.

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

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

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.

Activity codes and Parent Announcements

  • NIH activity codes (R01, R03, etc..)


  • Guide for parent proposals


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


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).

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)

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

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.


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

Application submission

  • NIH website on grants process is a useful resource


  • Submit electronically through 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:

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.


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.

Examples of sample proposals and funded grant abstracts.

  • R01: Research project proposals, NIAID


  • K 25: Quantitative career development, NHLBI


  • Funded grants:


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.

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).

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)

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.

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.

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

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.

What determines which awards are funded?

  • Scientific Merit (Study section result).

  • Program and/or Policy considerations

  • Availability of funds

Important dates for R01

Important web sites

  • General information NIH


  • Center for Scientific Review


  • Tutorial about grant application process at NIAID.


Important website contd.

  • Subscribe to NIAID News letter.


  • Program contact NIAID, Biostatistics program

    • Misrak Gezmu, [email protected]

Thank You.

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