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2. Charge to the Peer Review Advisory Committee (PRAC) Elias A. Zerhouni, M.D. Director National Institutes of Health 24 January 2005

3. Background Division of Research Grants (DRG) Advisory Committee Pre -1996 Focus: Advised DRG Director on peer review issues Problem: Many peer review issues are trans-NIH issues, not limited to CSR

4. Background… continued Peer Review Oversight Group (PROG) 1996 Charge by NIH Director Harold Varmus: Address review policy issues that are common to the entire NIH rather than focus on specific applications or study sections

5. Background… continued PROG 1996 - 2002 Reported to the Deputy Director for Extramural Research (DDER) and the NIH Director Met 11 times Topics included:  Scoring grant applications (review criteria)  Use of “lay” reviewers  Review of clinical research  Orientation/training of reviewers New CSR leadership reinvigorated the committee Focused on CSR, but often encountered NIH issues beyond CSR’s purview DRGAC CSRAC

6. Background… continued PROG 2002 - 2004 2002-2003 meetings focused on NIH’s response to Regulatory Burden reports Last met February 4-5, 2003 CSRAC Maintained an emphasis on CSR’s IRG and study section reorganization process Continued to encounter NIH peer review issues beyond CSR’s purview

7. Present Situation DDER 2005 Wants an advisory committee that focuses on broad trans-NIH peer review issues CSR Recognizes need for other Institute/Center (IC) input in addition to input from the scientific community CSRAC meetings in 2004 included IC leaders (from NIDDK, NIEHS & NIDCR) NIH needs an advisory committee that focuses on peer review policy and operations issues in the context of the overall extramural program Both Need an advisory committee structured in a way that resonates with NIH’s new governance structure

8. Peer Review Advisory Committee PRAC Broadly consider peer review in the context of other extramural program issues Solution

9. PRAC Advise NIH Director, Deputy Director for Extramural Research, and CSR Director on matters relating broadly to review procedures and policies for the evaluation of scientific and technical merit of applications for grants and awards. Advice provided to:  DDER and NIH Director on trans-NIH review policy and operations  CSR Director and/or other IC Directors on CSR or other NIH IC-specific review policy and operations Purpose

10. PRAC Co-chaired by CSR Director and another NIH IC leader (Dr. Berg) 16 committee members will include authorities knowledgeable in the fields relevant to the peer review mission of NIH. Members will include experts such as physicians, basic and clinical investigators, and educators as well as high-level NIH leadership As necessary, standing and ad hoc subcommittees may be established to perform specific functions within the Committee’s charge Structure

11. PRAC High level NIH leadership will include some members of the Extramural Activities Working Group (EAWG)  EAWG oversees CSR governance and has oversight over peer review related issues at NIH and reports directly to NIH Steering Committee  PRAC/EAWG overlap should facilitate resonance regarding peer review issues among components of NIH’s governance structure EAWG members serving on PRAC: Dr. Berg, Dr. Hammond, and Dr. Stanfield Fostering Harmonization Across NIH

12. PRAC Members and Co-chairs will be invited to serve terms up to four years Meetings will be held approximately three times a year at the discretion of the Co-chairs and will be open to the public As needed, PRAC will seek advice from special consultants, assemble ad hoc working groups, and convene conferences, workshops, or other activities Operations

13. PRAC Advise NIH Director and DDER on matters of policy and practice pertaining to the monitoring of, coordination of, and evaluation of peer review at NIH Advise CSR Director on matters of policy and practice relating to receipt, referral and peer review at CSR Advise Directors of other NIH Institutes and Centers (ICs) on the scope and manner of operation of peer review within their respective ICs Function – Specific Charge

14. PRAC PRAC’s recommendations and advice regarding CSR and IC specific matters will be made to the  Director and DDER, NIH AND AS APPROPRIATE  Director, CSR and/or relevant NIH IC Director Lines of Communication

15. PRAC Questions Regarding PRAC’s Charge and Discussion