NIH Grant Mechanisms
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
Funding Opportunity Announcements.
Application submission and where to get help
Review and Funding process.
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
Investigator(s) responsible for developing the
concepts, methods, and approach for a research
The Institute is responsible for establishing the
Both the awarding unit and the recipient have
Principal Investigator initiated. The researcher
works in the research interest of an Institute.
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
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
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 (new): support initial development of
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
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
Eg. 3 weeks summer Institute in statistics and
modeling of infectious diseases training (University
Examples of FAOs relevant to
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
Has special payline for R01s
NIAID 2008: 12% R01 vs 16% *R01
NIH website for Nis and ESIs.
NIH Pathway to Independence
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
NIH website on grants process is a useful
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
eRA Commons: NIH Electronic Research
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
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,
Selected Statistical Topics from
NIAID Statistical Methods Portfolio
Mathematical and experimental models for
Stat methods for evaluating vaccine efficacy.
Data-driven computational modeling of the
growth and spread of viruses
Nonparametric modeling of long-term
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
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
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.
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
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
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, firstname.lastname@example.org