Transcript 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,

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
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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)
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27 institutes and centers
Most institutes are disease specific.
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Eg. National Institute of Allergy and Infectious
Diseases (NIAID), National Cancer Institute (NCI).
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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
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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
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Grants
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Contracts
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Investigator(s) responsible for developing the
concepts, methods, and approach for a research
project.
The Institute is responsible for establishing the
detailed requirements.
Cooperative Agreement
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Both the awarding unit and the recipient have
substantial responsibility.
Research Grants.
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Unsolicited:
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Principal Investigator initiated. The researcher
works in the research interest of an Institute.
Solicited
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Request for Application (RFA):
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Initiative sponsored by one or more Institutes requesting
application in a well defined area.
Program Announcement (PA):
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Announcement in stated scientific area, one or more ICs.
NIH Extramural Activity Codes
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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)
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Provides individual grants to students and
scientists to develop careers in biomedical
research.
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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).
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Biomedical research career development.
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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).
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P01: Research Program Project.
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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
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Support shared resources and facilities for a
multidisciplinary research team or a group of
investigators focusing on a common research
topic.
Research Project
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R01: Discrete, specified project to be
performed by the Principal Investigator.
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R03: Provides support for preliminary
short-term projects in response to RFA,PA.
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R13: Provide funding for conferences to
exchange and disseminate information
related to program interests.
Research Project Contd.
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R15: Academic Research Enhancement
Award. To support research projects from
institutions that have not been major
recipients of NIH research grant funds
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R21 Exploratory/Developmental Grants,
submitted in response to RFA, PA .
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R21/R33(new): phase/phase II for research
begun as an R21 award.
R34/U01(Clinical Trial)
Planning /implementation
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R34 (new): support initial development of
clinical trial.
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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
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R41(phase I)/R42 (phase II): Small Business
Technology Transfer (STTR).
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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).
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Support projects to establish technical merit and
feasibility which lead to commercial products and
services
Training programs (T)
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T15: Short courses.
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T32: fund academic institutions for training
pre-doctoral and postdoctoral candidates.
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T35: provide research training during offquarters or summer periods.
Activity codes and Parent
Announcements
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NIH activity codes (R01, R03, etc..)
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http://grants.nih.gov/grants/funding/funding_prog
ram.htm
Guide for parent proposals
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http://grants.nih.gov/grants/guide/parent_announc
ements.htm
Check ICs requirement for activity
codes
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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.
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Funding Opportunity and notices weekly
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http://grants.nih.gov/grants/guide/index.html
Subscribe to newsletters
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http://www.niaid.nih.gov/ncn/newsletters/default_subscr
ibe.htm
Examples of Funding Opportunity
Announcements relevant to
statisticians.
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R25: Education projects
PA: Short Courses on Mathematical,
Statistical, and Computational Tools for
Studying Biological Systems (NIGMS and
other ICs)
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http://grants.nih.gov/grants/guide/pa-files/PA-09002.html
Eg. 3 weeks summer Institute in statistics and
modeling of infectious diseases training (University
of Washington).
Examples of FAOs relevant to
statisticians contd…
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T15: Short term courses
The Summer Institute for Training in
Biostatistics I and II (NHLBI and NCRR).
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http://grants.nih.gov/grants/guide/rfa-files/RFA-HL09-009.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)
Examples of FAOs relevant to
statisticians contd… (this week)
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R01, R21: Research project, Exploratory
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Research to advance vaccine safety:
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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/noticefiles/NOT-AI-09-050.html
New Investigator (NI) and Early
Stage Investigators (ESI)
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NI: Has not previously received a significant
award from NIH (R01, Challenge grant etc.)
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ESI: With in 10 years of completion of
terminal degree.
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Has special payline for R01s
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NIAID 2008: 12% R01 vs 16% *R01
NIH website for Nis and ESIs.
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http://grants.nih.gov/grants/new_investigators/
NIH Pathway to Independence
(K99/R00) award
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Must be within 5 years of terminal degree.
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Phase I: mentored support, 1-2 years fellowship
(K99).
Phase II: Independent research (R00).
Work towards preparing an R01 application
Application submission
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NIH website on grants process is a useful
resource
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http://www.grants.nih.gov/grants/grants_process.h
tm
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).
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eRA Commons: NIH Electronic Research
Administration website:
https://commons.era.nih.gov/commons/
Where to get help?
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Center for Scientific Review.
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Questions about application process and
study section assignment.
Questions about the merit review process:
Scientific Review Officer.
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http://cms.csr.nih.gov/
Where to get help? Contd…
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Program Contact: Program Officer
(Visit institute website to find contact person)
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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.
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R01: Research project proposals, NIAID
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K 25: Quantitative career development,
NHLBI
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http://www.niaid.nih.gov/ncn/grants/app/default.
htm
http://www.nhlbi.nih.gov/funding/training/redboo
k/k25models.htm
Funded grants:
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http://crisp.cit.nih.gov/
Selected Statistical Topics from
NIAID Statistical Methods Portfolio
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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.
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NIH Center for Scientific Review (CSR)
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Receives applications and gives ID
number.
Assigns each application to
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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
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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)
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~ 20 independent reviewers in each study
sections. (Each application will have 3/4
reviewers).
Actions
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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
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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*.
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*common reasons on statistical methods grants.
Pay Line
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Depending on the budget, a pay line will be
determined for each of the institutes.
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NIAID 2008 FY pay line (percentile or score).
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R01:12 %; 16% for new investigators
F31: 144, K: 154, R41/R42: 187
National Advisory Council
(Second level-Peer Review, Funding Recommendation)
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National Advisory Allergy and Infectious
Disease Council.
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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?
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Scientific Merit (Study section result).
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Program and/or Policy considerations
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Availability of funds
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
April
July
Earliest Project Start December
Date
Important web sites
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General information NIH
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Center for Scientific Review
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http://www.nih.gov/index.html
http://cms.csr.nih.gov/
Tutorial about grant application process at
NIAID.
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http://www.niaid.nih.gov/ncn/grants/default.htm
Important website contd.
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Subscribe to NIAID News letter.
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http://www.niaid.nih.gov/ncn/newsletters/default_s
ubscribe.htm
Program contact NIAID, Biostatistics program
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Misrak Gezmu, [email protected]
Thank You.