# Presentation: 527427

## Peer Review at the Center for Scientific Review 

- Joanna M. Watson, PhD
- Scientific Review Administrator
- Molecular Oncogenesis Study Section
- Oncological Sciences IRG
- Center for Scientific Review
- National Institutes of Health

##  NIH Process for a Research Grant

- National Institutes of Health

**Center for Scientific Review**

**Study Section**

- Institute

- Advisory Councils  / Boards

- Institute Director

- University/
- Research Center

- Research
- Grant Application

**Submits Application**

**  ****Allocates Funds**

**Initiates Research Idea**

**Conducts Research**

## Referral
Central Receipt Point
Institute Assignment
Referral to Integrated Review Groups (IRGs) and Study Sections
Scientific Review
Review of most research and research training applications for scientific merit

- Central Receipt Point
- Institute Assignment
- Referral to Integrated Review Groups (IRGs) and Study Sections
- Scientific Review
- Review of most research and research training applications for scientific merit

- What does CSR do?

## What Types of Mechanisms are Reviewed Where? 

- _Center for Scientific Review_
**Study Sections and Special Emphasis Panels**
**Research Projects (R01)**
**Pilot Studies (R21)**
**Small Grants (R03)**
**Fellowships (F32/33)**
**SBIR (R43/44)**
**STTR (R41/42)**
**Program Projects for some I/Cs**

- _Institute Review Offices_
- Scientific Review Groups and Contract Review Committees
- Training Grants (T32)
- Career Awards (K’s)
- Program Projects (P01)
- Centers (P20/30/50)
- Cooperative Agreements
- Multi-institutional clinical trials
- Applications for RFAs and complex PAs
- Contract Proposals for RFPs** **

## Central CSR Receipt of ApplicationsYesteryear...

## Central Receipt of ApplicationsToday...

## The CSR Referral Path for a Competing Grant Application 

**Receipt**** ****office**

**Breakout**

**Referral Officer**

**IRG Chief or Deputy Chief**

**Institute**

**SRA, IRG Study Section**

- Division of Receipt & Referral

- Integrated Review Group (IRG)

## Applications are Assigned to

- Institutes on the basis of:
- Overall mission
- Specific programmatic mandates and interests
- Initial IRG and Study Sections on the basis of:
- Specific review guidelines
- _[http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescription/ONCIRG/](http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescription/ONCIRG/)_

## Assignment to Study Sections

- Within an IRG, applications are assigned for review to
- Standing Study Sections: when the subject matter of the application falls within the purview of the referral guidelines for the study section
- Ad Hoc Special Emphasis Panels (SEPs): when the subject matter does not fit into any study section, or when assignment of an application to the most appropriate study section would create a conflict of interest.  Also used for special mechanisms (e.g., fellowships, SBIRs, AREAS), and for newly created study sections that are not yet chartered.

## CSR Review Divisions and IRGs

- Division of Biologic
- Basis of Disease

- Immunology
- (IMM) (11)
- Calbert Laing, Ph.D.

- AIDS and Related
- Research (AARR) (9)
- Ranga V. Srinivas, Ph.D.

- Division of Physiology
- and Pathology
- Michael Martin, Ph.D.

- Cardiovascular Sciences (CVS) (11)
- Joyce Gibson, D.Sc.

- Integrative, Functional
- and Cognitive Neuroscience (IFCN) (14)
- Christine Melchior, Ph.D.

-  Renal and Urological Sciences (RUS) (4)
- Daniel McDonald, Ph.D.

- Hematology (HEME) (5)
- Joyce Gibson, D.Sc.

- Digestive Sciences (DIG) (7)
- Mushtaq Khan, Ph.D.

- Division of Molecular
- and Cellular Mechanisms
- Donald Schneider, Ph.D.

- Bioengineering Sciences and
- Technologies (BST) (7)
- George Chacko, Ph.D.

- Biology of Development and
- and Aging (BDA) (6)
- Sherry Dupere, Ph.D.

- Biological Chemistry and Macromolecular Biophysics (BCMB) (12)
- John Bowers, Ph.D.

- Cell Biology (CB) (8)
- Noni Byrnes, Ph.D.

-  Genes, Genomes and
- Genetics (GGG) (11)
- Richard Panniers,  Ph.D

- Molecular, Cellular and
- Developmental
- Neuroscience (MDCN) (15)
- Carole Jelsema, Ph.D.

- Respiratory Sciences (RES) (4)
- Mushtaq Khan, Ph.D.

- Musculoskeletal, Oral, and Skin Sciences (MOSS) (12)
- Daniel McDonald, Ph.D.

## Referral in the ONC IRG

**Translational/Therapeutic**

**Fellowship, SBIR/STTR**

**Basic**

**CE**** **(Victor Fung)
**CG**** **(Zhiqiang Zou)
**MONC**** **(Joanna Watson)
**CAMP**** **(Elaine Sierra-Rivera)
**TCB**** **(Angela Ng)
**TME**** **(Eun Ah Cho)
**TPM**** **(Manzoor Zarger)

**CDP**** **(Sally Mulhern)
**CBSS**** **(Mary Bell)
**RTB**** **(Bo Hong)
**CII**** **(Steven Scholnick)
**DMP**** **(Syed Quadri)
**DT**** **(Sharon Gubanich)
**BMCT**** **(Suzanne Forry-Schaudies)
**CONC**** **(John Meyer)

**F09**** **(Lambratu Rahman)
**ONC-L 10**** **(Hungyi Shau)
**ONC-L 12**** **(Hungyi Shau)
**ONC-R**** **(Bo Hong)

**Dr. Elaine Sierra-Rivera**

## What does the Scientific Review Administrator do?

- Performs administrative and technical review of applications
- Recruits reviewers
- Must meet particular requirements
- Makes assignments
- Manages study section meeting
- Prepares summary statements

## Orientation
Streamlining
Discussion & Scoring

	REVIEW CRITERIA:		Significance		Approach		Innovation		Investigator		Environment		Human Subjects         	Vertebrate Animals

		Budget	
		Model Organism Sharing
		Data Monitoring Plan

- Streamlining
- Discussion & Scoring
- 	**REVIEW CRITERIA:*****	******	***Significance		Approach		Innovation		Investigator		Environment		Human Subjects         	Vertebrate Animals
- 		Budget
- 		Model Organism Sharing
- 		Data Monitoring Plan

- What Happens In A Study Section?

- “Scoreable Issues”

- “Non-Scoreable Issues”

## Study Section Meeting Procedures

- Reviewers receive ALL applications*
- Assigned reviewers present a summary of their critiques
- Open discussion among ALL reviewers
- Range of scores set
- All reviewers vote and score each application
- Discussion of budget amount and time, and other issues

***Reviewers in conflict or potential conflict are **_**NOT**_** allowed in the room during discussion and do not score or see the applications.**

## Study Sections Actions and Outcomes

- Unscore (streamline)
- Initially identified on the basis of the average preliminary scores
- Consensus must be reached among entire study section
- Score (Merit Rating or Priority Score assigned)
- 1.0 (best) to 5.0 (worst)
- R01s percentiled against study section or CSR all
- Percentiles derived from previous two rounds and current round
- For some institutes, R21s are percentiled using the R01 percentile base for the study section, but the R21s are not included in the percentile base
- Not Recommended for Further Consideration (NRFC)
- Application has serious ethical problems in Human Subject or Animal use or significant scientific flaw
- Defer
- Review Committee needs more information to decide on the scientific merit of the application or problem identified during the review

## 	Summary Statement

- The summary statement is the _official document_ of the review of the application. At CSR, all summary statements released within 30 days of the meeting.
- A summary statement is prepared for all applications and includes:
- Face page administrative information
- Investigator, Program Director contact information, review group, council round,
- Priority Score and Percentile Ranking (if scored)
- Human subjects, animal welfare codes
- Requested budget
- Resume & Summary of Discussion (if scored)
- Description of the proposed studies (if scored)
- Reviewers’ Critiques
- Assessment of Human Subjects, Inclusion of Gender, Minority, and Children
- Assessment of Vertebrate Animal Welfare
- Budget Recommendations (if scored)
- Administrative Notes
- i.e., Budget overlap, Model organism sharing plan missing
- Meeting Roster

## Overall Timeframe from Application Submission to Award

- Three overlapping cycles occur per year:

- JAN    FEB    MAR    APR   MAY   JUN     JUL     AUG    SEP   OCT    NOV     DEC    JAN   FEB    MAR    APR    MAY    JUN     JUL