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Financial Conflicts of Interest in Human Subjects Research

Explore the issue of conflicting reporting requirements in managing financial conflicts of interest in human subjects research. Learn how to streamline procedures by harmonizing IRB and COIC requirements. Impacting IRB administration, COIC analysts, researchers, and more. Written policies from HRPs and PPMs guide the changes needed.

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Financial Conflicts of Interest in Human Subjects Research

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  1. Financial Conflicts of Interest in Human Subjects Research Nicole Walters IRB Administration

  2. What’s the problem?

  3. Inconsistent Reporting Requirements

  4. Two Systems for Reporting

  5. Inconsistent Management Plans

  6. solutions

  7. Harmonize IRB and COIC reporting requirements • Streamline reporting and review procedures • Create a single management plan for each conflict

  8. Who is Impacted? • IRB Administration and IRB Committees • RCI analysts and COIC • Researchers and research staff

  9. Written Policies and Procedures IRB Human Research Protection Program (HRP) • HRP-055: Financial Conflicts of Interest UD Davis Policy & Procedure Manual (PPM) • PPM 230-05: Individual Conflicts of Interest Involving Research • PPM 230-07: Public Health Service Regulations on Objectivity in Research

  10. What’s Changing?

  11. What’s NOT changing? • PPM 230-07: Public Health Service Regulations on Objectivity in Research

  12. To be continued…

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