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Published byよりお うづき Modified over 5 years ago
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Financial Conflicts of Interest in Human Subjects Research
Nicole Walters IRB Administration
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What’s the problem?
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Inconsistent Reporting Requirements
COIC Thresholds IRB Thresholds
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Two Systems for Reporting
IRB Review IRBNet COIC Review eCOI
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Inconsistent Management Plans
IRB Management Plan COIC Management Plan
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solutions
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Harmonize IRB and COIC reporting requirements
Streamline reporting and review procedures Create a single management plan for each conflict
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Who is Impacted? IRB Administration and IRB Committees
RCI analysts and COIC Researchers and research staff
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Written Policies and Procedures
IRB Human Research Protection Program (HRP) HRP-055: Financial Conflicts of Interest UD Davis Policy & Procedure Manual (PPM) PPM : Individual Conflicts of Interest Involving Research PPM : Public Health Service Regulations on Objectivity in Research
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What’s Changing? HRP-055 Update PPM COIC SOP *New*
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What’s NOT changing? PPM : Public Health Service Regulations on Objectivity in Research
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To be continued…
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