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Conflicts of Interest at USF: An Institutional Approach . Presented by Camille A. McWhirter, J.D. USF Health Office of Research Office of Research Compliance . Objective. To assess and monitor conflicts of interest Across diverse areas Involving faculty, staff and students
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Conflicts of Interest at USF:An Institutional Approach Presented by Camille A. McWhirter, J.D. USF Health Office of Research Office of Research Compliance
Objective • To assess and monitor conflicts of interest • Across diverse areas • Involving faculty, staff and students • With varying risk factors • Different degrees of external regulation • Under the control of separate University administrators
Problems with Existing COI Infrastructure • No oversight or management for some types of COI (e.g., Code of Ethics for Public Officers & Employees, vendors) • No oversight or management for some types of employees (e.g., graduate students, OPS) • Poor document control/approval processes
Problems with Existing COI Infrastructure (con’t) • No consistency in identifying or reporting of outside activity • No consistent enforcement/monitoring of procedures that do exist • COI review responsibility delegated to Chairs who have no training in COI review
Problems with Existing COI Infrastructure (con’t) • Employees and administration confuse the different types of COI and the different processes for managing conflicts (outside activity process vs. financial interest disclosure) • No coordination or communication among different offices dealing with COI • Uncoordinated training efforts lead to inconsistent messages to employees on COI issues
Integration: Why? • Uniform treatment of diverse COI areas • Clear responsibility for oversight/ development of policies and processes • Centralized expertise and information for benefit of end users • Attention afforded to high risk and under- regulated areas of COI
COI Workgroup of the Institutional Compliance & Ethics Council
COI Workgroup Responsibilities • Identify oversight responsibility for various areas of COI (e.g., institutional, outside activity, financial interests in research) • Review/recommend policies • Assess internal controls • Develop training tools/conduct training on COI • Represent COI on Institutional Compliance & Ethics Council • Accountability and outcome measures for administrators with COI responsibility
Potential Membership • COI Workgroup • Olga Joanow (Faculty Outside Activity & Nepotism/Health) • Patsy Bickel (Industry Relationships in Medicine/Health) • Tom DiBella (Vendor/USF) • Vinita Witanachchi (Review of Financial Interests in Research/USF) • Liz O’Connell (Disclosure & Reporting of Financial Interests in Research/USF) • Michael Stephens (Staff Nepotism and OA/USF & Health) • Valerie McDevitt (Tech Transfer/USF) • Dwayne Smith (Faculty Outside Activity & Nepotism/USF) • TBD (Student Financial Aid/USF) • TBD (Faculty/USF) • TBD (Faculty/Health)