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Archived File. The file below has been archived for historical reference purposes only. The content and links are no longer maintained and may be outdated. See the OER Public Archive Home Page for more details about archived files. CSR Best Practices – Conflict of Interest. Noni Byrnes

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  1. Archived File The file below has been archived for historical reference purposes only. The content and links are no longer maintained and may be outdated. See the OER Public Archive Home Page for more details about archived files.

  2. 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 HumanServices

  3. 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

  4. 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.

  5. 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

  6. 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

  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. 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

  9. OUT-OF-SRG Versus OUT-OF-ROOM Conflicts (and ambiguous situations requiring SRO judgment) • Member’s 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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 reviewer’s institution

  16. 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

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