CSR Best Practices Conflict of Interest

1
CSR Best Practices Conflict of Interest
Noni Byrnes Chief, Cell Biology Integrated Review
Group
PRAC, November 3, 2008
National Institutes of HealthU.S. Department of
Health and Human Services
2
BACKGROUND

• Initiated by Toni Scarpa to increase consistency
  in practice related to conflict-of-interest at
  CSR.
• Member Conflicts (member SEPs, applications from
  retired members)
• Other types of conflict situations
• Institutional conflicts
• SRO Conflicts

3
GOAL

• Develop an easy-to-use, hands-on document to
  provide guidance to CSR SROs in interpretation of
  existing NIH peer review conflict-of-interest
  policies, and to establish best and consistent
  practices for CSR staff.
• The goal was not to design or develop new peer
  review policy.

4

• Conflict of Interest Best Practices Committee
• (Sub Committee of CSR Best Practices Committee
  Cheryl Kitt)
• All 4 review divisions, all levels of
  organization at CSR
• Noni Byrnes, Chief, DMCM
• Cathleen Cooper, SRO, DBBD
• Rene Etcheberrigaray, Chief, DCPS (Director,
  DNDA)
• Joy Gibson, Chief, DPP (Acting Director, DCTS)
• Don Schneider, Director, DMCM
• Anne Stroh, Ethics Officer

5
SOURCES

• NIH GAM, CFR, NIH Conflict forms, existing
  blanket waivers, SRO Handbook
• Extensive discussions within the committee
• Feedback from CSR SROs, IRG Chiefs, Division
  Directors and CSR Director/Deputy Director
• Feedback from EPMC, OER

6
HIGHLIGHTS OF THE DOCUMENT

• Distinguishing out-of-SRG versus out-of-the-room
  conflicts
• Guidance on SRO actions in specific conflict
  situations
• Conducting member SEPs, review of applications
  from former members
• Institutional Conflicts

7
HIGHLIGHTS OF THE DOCUMENT

• Distinguishing out-of-SRG versus out-of-the-room
  conflicts
• Guidance on SRO actions in specific conflict
  situations
• Conducting member SEPs, review of applications
  from former members
• Institutional Conflicts

8
OUT-OF-SRG Versus OUT-OF-ROOM Conflicts (and
ambiguous situations requiring SRO judgment)

• Members relative, etc.
• Intellectual involvement of the member
• Letter from the member
• PI is collaborator of the member
• Collaborator on application is collaborator of
  member
• Former collaborators
• Mentor-Mentee relationships

9
HIGHLIGHTS OF THE DOCUMENT

• Distinguishing out-of-SRG versus out-of-the-room
  conflicts
• Guidance on SRO actions in specific conflict
  situations
• Conducting member SEPs, review of applications
  from former members
• Institutional Conflicts

10
GUIDANCE ON SRO ACTIONS IN SPECIFIC SITUATIONS

• PI provides names of potential reviewers or list
  of people in conflict
• Sending application information to reviewers
  prior to assignments
• Misconduct allegations during the meeting
• Conflict discovered during the meeting

11
HIGHLIGHTS OF THE DOCUMENT

• Distinguishing out-of-SRG versus out-of-the-room
  conflicts
• Guidance on SRO actions in specific conflict
  situations
• Conducting member SEPs, review of applications
  from former members
• Institutional Conflicts

12
CONDUCTING MEMBER SEPS

• Involvement of the SRO of the study section
• Avoiding use of current members as reviewers
• Avoiding reciprocal assignments (tit-for-tat
  situations)
• Using former members as reviewers in member SEPs
• Review of applications from recently retired
  members

13
HIGHLIGHTS OF THE DOCUMENT

• Distinguishing out-of-SRG versus out-of-the-room
  conflicts
• Guidance on SRO actions in specific conflict
  situations
• Conducting member SEPs, review of applications
  from former members
• Institutional Conflicts

14
INSTITUTIONAL CONFLICTS

• Differentiating dyads and institutional conflicts
• Financial or employment relationships
• For-profit institutions
• Federal institutional conflicts
• Multi-component institutional conflicts
• Collaborators on application from reviewers
  institution

15

• Conflict of Interest Best Practices Committee
• Noni Byrnes, Chief, DMCM
• Cathleen Cooper, SRO, DBBD
• Rene Etcheberrigaray, Chief, DCPS (Director,
  DNDA)
• Joy Gibson, Chief, DPP (Acting Director, DCTS)
• Don Schneider, Director, DMCM
• Anne Stroh, Ethics Officer