NIH Grant Mechanisms and

Funding Process

Misrak Gezmu, Ph.D.NIH, NIAID

ASA Caucus of Academic representativesFor Chairs of Programs in Statistics/ Biostatistics

August 1, 2009ASA, Alexandria, VA

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.

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..) http://grants.nih.gov/grants/funding/funding

_program.htm

Guide for parent proposals http://grants.nih.gov/grants/guide/parent_announc

ements.htm

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_

subscribe.htm

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/P

A-09-002.html

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). http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-

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)

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/NOT-AI-09-050.html

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/

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 http://www.grants.nih.gov/grants/

grants_process.htm 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). eRA Commons: NIH Electronic Research

Administration website: https://commons.era.nih.gov/commons/

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/

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 http://www.niaid.nih.gov/ncn/grants/app/

default.htm K 25: Quantitative career development,

NHLBI http://www.nhlbi.nih.gov/funding/training/

redbook/k25models.htm Funded grants:

http://crisp.cit.nih.gov/

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

Cycle IAIDS/Others

Cycle IIAIDS/Others

Cycle IIIAIDS/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

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

Important website contd.

Subscribe to NIAID News letter. http://www.niaid.nih.gov/ncn/newsletters/

default_subscribe.htm

Program contact NIAID, Biostatistics program Misrak Gezmu, mgezmu@niaid.nih.gov

Thank You.