VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R013

Edward Via College of Osteopathic Medicine

Policy Order No: R013 Effective Date:

November 1, 2013 November 21, 2016

Revised:

Signature on File __________________________ Dixie Tooke-Rawlins, D.O. President and Provost ___________________________________________________________________________________ F INANCIAL C ONFLICTS OF I NTEREST IN R ESEARCH ___________________________________________________________________________________ 1. PURPOSE..............................................................................................................................................2 2. GENERAL STATEMENT ..................................................................................................................2 3. DEFINITIONS ......................................................................................................................................2 4. RESPONSIBILITIES AND DUTIES .................................................................................................5 4.1. Responsibilities of the College ........................................................................................................5 4.2. Responsibilities of the Investigators................................................................................................5 5. REPORTING FINANCIAL INFORMATION TO THE COLLEGE.............................................5 6. ASSESSING & DETERMINING FINANCIAL CONFLICT OF INTEREST IN RESEARCH .6 6.1. Review Procedure............................................................................................................................6 6.2. Determining Financial Conflict of Interest......................................................................................7 6.3. Procedures on Compelling Circumstances ......................................................................................7 7. MANAGEMENT OF FINANCIAL CONFLICTS OF INTEREST................................................8 7.1. Monitoring .......................................................................................................................................8 7.2. Management Plan ............................................................................................................................9 7.3. Reconsideration ...............................................................................................................................9 7.4. Disclosure during Ongoing Research ..............................................................................................9 7.5. Retrospective Disclosure .................................................................................................................9 8. REPORTING REQUIREMENTS FOR PHS-FUNDED RESEARCH.........................................10 8.1. Reporting Elements .......................................................................................................................10 8.2. Mitigation Reports.........................................................................................................................11 9. VIOLATIONS AND ENFORCEMENT...........................................................................................11 10. SUBRECIPIENT REQUIREMENTS FOR PHS-FUNDED RESEARCH...................................12 11. RECORDS AND COMPLIANCE ....................................................................................................12 12. TRAINING REQUIREMENTS ........................................................................................................12 13. PUBLIC ACCESSIBILITY...............................................................................................................13 14. DURATION OF POLICY .................................................................................................................13

Financial Conflicts of Interest in Research Policy

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