Public Representation on Scientific Review Panels at the NIH

1
Public Representation on Scientific Review Panels
at the NIH

• NIH Directors 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

2
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

3
Establish Baseline Understandings

• Issue of Terminology
• Public member/ study participant expert.
• Its 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 todays discussions in a
  future venue.

4
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
  pictureasking, 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

5
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

6
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

7
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

8
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

9
Synergy for Enhancing the Peer Review Process

• Answering Dr. Scarpas 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

10
Continuing the Dialogue

• April 20 21, 2006 COPR Meeting
• NIH Public Trust Initiative
• NIH Roadmap, including CTSAs
• Office of Portfolio Analysis and Strategic
  Initiatives
• Trans-NIH Dialogue on Public Members in Peer
  Review
• Possible pilot program?
• Basis for inclusion decisions?