# Presentation: 216750

## 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

## 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

## Establish Baseline Understandings

- Issue of Terminology –
- Public member/ study participant expert.
- It’s the intent of the concept we are focused on today.
- Study Participant Experts (SPEs) –
- Intent is to have carefully defined and structured involvement.
- 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.

## 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

## What is the VALUE ADDED?

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

## 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

## 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

## 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

## 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

## 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?