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2. Public Representation on Scientific Review Panels at the NIH NIH Director’s Council of Public Representatives (COPR) Presenters: Christina Clark and Marjorie Mau, M.D. Peer Review Advisory Committee Meeting, NIH January 23, 2006 Hyatt Hotel, Bethesda, MD

3. Background Scientific Peer Review process at the NIH –“gold” standard in the field Recognize the challenges in this process: to recruit and train the best reviewers; to effectively evaluate a broad range of clinical research; to increase transparency, accountability and uniformity in the system Current changes in process; CSR leadership challenge for suggestions and ideas: Study participant expert perspective offered as an innovative adjustment intended to address a missing element in the process

4. Establish Baseline Understandings Issue of Terminology – 1.Public member/ study participant expert. 2.It’s the intent of the concept we are focused on today. Study Participant Experts (SPEs) – 1.Intent is to have carefully defined and structured involvement. 2.Purpose is to enhance reviews and achieve scientific goals. Goal today is to initiate a dialogue and find a mechanism to continue today’s discussions in a future venue.

5. VALUE ADDED: The Rationale for Including SPEs in Peer Review –Perspective of the target population missing in the review of clinical research applications –Clinicians often removed from the people who are the target population –Scientific reviewers trained to focus on the big picture…asking, how will this advance science? –Scientific reviewers trained to focus on technical issues and details –SPEs provide a bridge between the clinicians and the study participants in the review process –SPEs focus on issues that make the research feasible in the real world

6. What is the VALUE ADDED? Study Participant Experts provide important perspectives on… 1.Study design issues that affect recruitment and/or retention of subjects 2.Human subject protections provisions 3.Plans for involvement of women, minorities and children 4.Issues related to the effectiveness of the community outreach plan, if applicable 5.Community- or service-based issues/plans 6.Other issues that are important to the target populations

7. Who are Study Participant Experts? Represent the perspective of study participants who need to be recruited and retained Experience and skills to fill that role Screened/selected Trained in peer review Also: Confidentiality, Conflict of Interest Screened/Selected/ Trained in Peer Review Experience with disease, population/ Willing and able to represent a broad perspective/No agenda Segment of the Public – Interested in Research

8. Study Participant Experts do NOT … Advocate for or against any topic, type, or scope of research Represent their advocacy organization or their personal causes/stories Discuss the potential funding of the application or related research Comment on the science per se, unless otherwise qualified or requested Treat participation in peer review like any other advocacy or public role

9. When is it appropriate to include Study Participant Experts? Applications which include human subjects (clinical, population, community, service, etc.) Scientific Review Administrator (SRA) decides to include this expertise in assembling the panel SRA selects the specific individual Study Participant Expert (s) –NCI-CARRA program provides lists of screened, trained and selected SPEs to SRAs to choose from

10. Synergy for Enhancing the Peer Review Process Answering Dr. Scarpa’s challenge for good ideas and suggestions Enhance the system to identify and conduct the best science Ensure appropriate participant recruitment & retention to protect and maximize resources

11. Continuing the Dialogue April 20 & 21, 2006 COPR Meeting NIH Public Trust Initiative NIH Roadmap, including CTSA’s Office of Portfolio Analysis and Strategic Initiatives Trans-NIH Dialogue on Public Members in Peer Review Possible pilot program? Basis for inclusion decisions?