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Financial Conflicts of Interest in Human Subjects Research. Nicole Walters IRB Administration. What’s the problem?. Inconsistent Reporting Requirements. Two Systems for Reporting. Inconsistent Management Plans. solutions. Harmonize IRB and COIC reporting requirements
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Financial Conflicts of Interest in Human Subjects Research Nicole Walters IRB Administration
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 NOT changing? • PPM 230-07: Public Health Service Regulations on Objectivity in Research