The field of Biostatistics and i

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					      NIH Grant Mechanisms
         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

   Overview of NIH extramural activities.
   NIH Funding mechanisms and Activity
   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
   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
   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
       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
       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 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
   P30: Center Core Grants
       Support shared resources and facilities for a
        multidisciplinary research team or a group of
        investigators focusing on a common research
            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
   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
           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
   NIH activity codes (R01, R03, etc..)

   Guide for parent proposals
    Check ICs requirement for activity
   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
   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
       Phase II: Independent research (R00).

   Work towards preparing an R01 application
             Application submission

   NIH website on grants process is a useful
   Submit electronically through
    using the SF424 (R&R) application
   You also must register with the eRA
    Commons (your institution must do this for
       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,
   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
       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

   Biostatistical Methods and Research Design
   AIDS Clinical Studies and Epidemiology
    (ACE; statistical methods relevant to HIV
   Modeling and Analysis of Biological Systems
    (MABS; modeling complex biological
     1st Level Peer Review, Scientific
               (Study Section Responsibilities)

   ~ 20 independent reviewers in each study
    sections. (Each application will have 3/4
   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
       Makes funding recommendations to NIAID
        Director based on program priorities and policy
    What determines which awards are

   Scientific Merit (Study section result).

   Program and/or Policy considerations

   Availability of funds
                   Important dates for R01

                     Cycle I         Cycle II             Cycle III
                     AIDS/Others     AIDS/Others          AIDS/Others

Submission date      May 7/March 5   September7/June 5    January 7/October 5

Scientific Merit     June - July     October - November   February - March

Advisory Council     September -     January - February   May - June
Review               October

Earliest Project Start December      April                July
                Important web sites

   General information NIH
   Center for Scientific Review
   Tutorial about grant application process at
            Important website contd.

   Subscribe to NIAID News letter.

   Program contact NIAID, Biostatistics program
       Misrak Gezmu,
Thank You.