# Presentation: 807670

## Peer Review Process for NIH Grant Applications

**Ann Hardy, Dr.P.H. **
**Scientific Review Administrator**
**    ****Center for Scientific Review, NIH**

## Overview

**How grants fit into NIH’s mission**
**Overview of peer review process**
**Study sections that review statistical/quantitative methods grants**
**Highlight a few issues**
**Recent changes to application instructions (*Human subjects)**
**New directions for grant review**

## National Institutes of Health

**NIH Mission:**
**Promote biomedical and behavioral research to help improve the health of all Americans**
**Carried out through 27 Institutes and Centers**

##         Allocation of FY 2005 NIH Budget               (dollars in billions)

**    ****Extramural Research**
**$24.1 (84%)**

**      ****NIH In-house **
**         ****Research **
**             ****$4.7 **
**             ****(16%)**

** ****24/27 Institute/Centers award extramural funds**

***        ******Allocation of ******FY 2005 NIH Budget******               (dollars in billions)***

## Extramural Funding Mechanisms

**Grants**
**Unsolicited**
**In response to RFA, Program Announcement (PA, PAR, PAS)**
**Cooperative agreements**
**Contracts**

## Grant Mechanisms

**R series (research projects)**
**R01 -individual research**
**R03- small, short-term**
**R21- exploratory/developmental**
**R15 – certain inst. with little NIH funding**
**Other series**
**F (fellowship)**
**T (Training)**
**P (Large program projects/centers)**

## A Typical Institute/Center

**Office of the IC**
**Director**

**National**
**Advisory**
**Council**

**Board of**
**Scientific**
**Counselors**

**Extramural**

**Scientific**
**Programs**

**Grants**

**Contracts**

**Intramural**

**Laboratory**
**Studies**

**Clinical**
**Studies**

## Dual Review System for Grant Applications

***Dual Review System for Grant Applications***

**  ****Second Level of Review**
**Council**
**Assesses Quality of  SRG**
** ****Review**
**Makes Recommendation to**
**Institute on Funding**
** ****Evaluates Program Priorities**
** ****and Relevance**
** ****Advises on Policy**

**     ****First Level of Review**
**Scientific Review Group **
**Provides Initial Evaluation of Scientific Merit**
**Rates Applications and Makes       Recommendations Regarding Budget and Duration **

## Review Process for a Research Grant

**National Institutes of Health**

**Center for Scientific Review**

**Study Section**

**Institute**

**Advisory Councils and Boards**

**Institute Director**

**School or Other **
**Research Center**

**Research**
**Grant Application**

**Submits Application**

**  ****Allocates**** Funds**

**Initiates Research Idea**

**Conducts Research**

** ****Assigns to IC &    IRG/ Study Section  **

** ****Reviews for        Scientific Merit**

**  ****Evaluates for     Relevance**

**Recommends        Action**

**   ****Takes final action**

## Typical Timeline for a New Individual Research Project Grant Application (R01)

- Submit in February (June, October)
- Review in June (October, February)
- Council in September (January, May)
- Earliest award in December (April, July)

- Cycle 1----
- Cycle 2----
- Cycle 3----

- There are three overlapping cycles per year:

## Pre-submission	

**Follow instructions (PHS 398) – format, sections, length, deadlines**
**PI can talk to program official before submission**
**PI can request the funding institute and review by a specific study section **

## PHS Research Grant

***    ******Application Kit (form PHS 398)***

**Recent changes:**
**http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-039.html**
**READ the Instructions:**
**http://grants.nih.gov/grants/funding/phs398/instructions2/phs398instructions.htm**

## Upon Receipt:

**Unique application number assigned**
**	**** ****1 R01   CA09999-01A1**
**Assigned to institute and study section**
**70%  applications reviewed in one of ~ 250 study sections in Center for Scientific Review (CSR)**
**PI is notified**

## Scientific Review Groups or Study Sections

**Objective, fair, and competent review of scientific and technical merit**
**Scientific Review Administrators:**
**Organize the review meeting**
**Ensure procedures and policies are followed**
**Communicate results of review **

## What Study Sections Review Statistical Grants?

**Biostatistical Methods and Research Design (BMRD)**
**SSPS – econometrics, survey methods**
**GCAT – microarray, pop genetics, gene mapping**
**BDMA – comp biol, bioinform, basic science**
**MABS- modeling complex bio systems (cellular/molec level)**
**BCHI – large clinical data base development, data mining**

## What Does BMRD Review?

**Development of quantitative methods and/or assoc. technologies to address statistical/mathematical problems, research design, or methodological issues**
**Relevant to biomedical/clinical, behavioral, social sciences (clinical and pop-based science)**
**Ex:  sample selection, bias, survey methods, study/trial design, measurement, psychometrics, analysis, modeling **

## What Study Sections Review Statistical Grants?

**Biostatistical Methods and Research Design (BMRD)**
**SSPS – econometrics, survey methods**
**GCAT – microarray, pop genetics, gene mapping**
**BDMA – comp biol, bioinform, basic science**
**MABS- modeling complex bio systems (cellular/molec level)**
**BCHI – large clinical data base development, data mining**

## BMRD Study Section

**21 regular members**
**Active, productive researcher in field**
** ****Work effectively in group context**
**Impartial**
**4-year terms**
**Cover major topical areas**
**Diversity: institutional, geographic, gender, racial/ethnic**

## Institutes Sponsoring BMRD Grants

**20/24 Funding institutes have had grants reviewed in BMRD**

**28%**

**16%**

**9%**

**7%**

**7%**

**5%**

**5%**

**15%**

**4%**

**4%**

## Pre-review Activities

**Recruit additional reviewers (temporary members) to cover expertise**
**Assign applications; each has 3-4 reviewers **
**     ****(expertise, conflict, continuity)**
**Provide review materials, training, information **
**	****on policies and procedures**
**Arrangements for review meeting**

## What happens in the study section meeting?

**Closed**
**Orientation**
**Determine streamlined proposals**
**Review**
**Discussion of scientific merit, human subjects, inclusion**
**Everyone scores**
**Scores range from 1.0-5.0 (best – worst)**
**Budget**

## Streamlining

**Those applications that the entire group agrees would fall below the median score **
**Streamlined proposals are not scored or discussed**
**Summary statement with reviewer’s written critiques are provided**
**Make more efficient use of time at meetings**

## Post-meeting

**Scores – averaged, multiplied by 100, percentiled (based on current and 2 previous rounds)**
**Scores and Percentiles – available on NIH Commons or from PO- DON’T CALL ME**
**Summary statements – available within 6-8 weeks**
**Funding decisions are made by Institutes with input from Advisory Council**

##  Human Subjects and Inclusion

**New guidance on research involving the use of “coded, private information”**
**	****http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf**
**Changes reflected in new PHS 398 instructions**
**http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-020.html**

## Human Subjects

**Definition:**
**Not human subjects – non-living, or non-identifiable information (must document)**
**No code key**
**Provided w/ agreement to not release identifying info**
**Policies prohibiting release (Census data)**
**No investigator has access to key or identifiers**

**...****living individual about whom an investigator obtains either **_[(1)](slide1.xml)__ data through intervention or interaction with the individual, or __[(2)](slide2.xml)__ identifiable private information...._

## Human Subjects

**	****	****	****	****	****     **_**Previous**_**     **_**New**_
**1/Simulated data, non-**
** ****human, not at indiv level****	****         No HS    No HS**
**2/ Collecting data thru **
**interaction/intervention****	****	****HS****	****    HS**
**3/ Existing private info w/ ID**
**	****  ****No access to ID****	****	****	****E4****	****    No HS**
**	****  ****1+ investig w/ access****	**** ****	****HS****	****    HS**

## Research involving Human Subjects must  address:

**Risks to subjects**
**Protections**
**Potential benefits**
**Importance of knowledge to be gained**
**Inclusion of women, minorities, and children (less than 21 years)**

## What’s new

**CSR has a new Director: **
**	****	****	****Dr. Antonio Scarpa**
**Speed up review and feedback process**
**Greater use of electronic technology**
**Applications on CD for reviewers**
**electronic submission**
**NIH Commons – scores, summaries, posting reviews and materials**
**“****on-line” meetings**

## Useful web sites

**NIH site: http://www.nih.gov/**
**Office of Extramural Research:**
**	****	****http://grants1.nih.gov/grants/**
**Program Announcements: **
**	****http://grants.nih.gov/grants/guide/pa-files/index.html**
**CSR site: http://www.csr.nih.gov/**
**NIAID’s “All About Grants” tutorials:**
**www.niaid.nih.gov/ncn/grants/default.htm**

## My Contact Info

**Ann M. Hardy, Dr.P.H.**
**Center for Scientific Review, NIH**
**6701 Rockledge Dr., Room 3158, MSC 7770**
**Bethesda MD  20892 ( 20817 for overnight mail)**
**Tel: 301-435-0695**
**Fax: 301-480-1056**
**Email: hardyan@csr.nih.gov**