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

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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.

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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.

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NIH Extramural activity

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

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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.

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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.

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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)

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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.

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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.

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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.

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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.

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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.

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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

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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

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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.

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Activity codes and Parent Announcements

• NIH activity codes (R01, R03, etc..)
• http//grants.nih.gov/grants/funding/funding_progr
  am.htm
• Guide for parent proposals
• http//grants.nih.gov/grants/guide/parent_announce
  ments.htm

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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_s
  ubscribe.htm

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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).

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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-H
  L-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)

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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/NO
  T-AI-09-050.html

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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/

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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

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Application submission

• NIH website on grants process is a useful
  resource
• http//www.grants.nih.gov/grants/grants_process.ht
  m
• Submit electronically through Grants.gov using
  the SF424 (RR) 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.go
  v/commons/

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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/

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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.

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Examples of sample proposals and funded grant
abstracts.

• R01 Research project proposals, NIAID
• http//www.niaid.nih.gov/ncn/grants/app/default.ht
  m
• K 25 Quantitative career development, NHLBI
• http//www.nhlbi.nih.gov/funding/training/redbook/
  k25models.htm
• Funded grants
• http//crisp.cit.nih.gov/

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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.

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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).

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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)

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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.

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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.

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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).
• R0112 16 for new investigators
• F31 144, K 154, R41/R42 187

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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.

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What determines which awards are funded?

• Scientific Merit (Study section result).
• Program and/or Policy considerations
• Availability of funds

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Important dates for R01
Cycle I AIDS/Others Cycle II AIDS/Others Cycle III AIDS/Others
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
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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

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Important website contd.

• Subscribe to NIAID News letter.
• http//www.niaid.nih.gov/ncn/newsletters/default_s
  ubscribe.htm
• Program contact NIAID, Biostatistics program
• Misrak Gezmu, mgezmu_at_niaid.nih.gov

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• Thank You.