Financial Conflicts of Interest in Human Subjects Research

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Presentation transcript:

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

What’s the problem?

Inconsistent Reporting Requirements COIC Thresholds IRB Thresholds

Two Systems for Reporting IRB Review IRBNet COIC Review eCOI

Inconsistent Management Plans IRB Management Plan COIC Management Plan

solutions

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

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

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

What’s Changing? HRP-055 Update PPM 230-05 COIC SOP *New*

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

To be continued…