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Office of Regulatory Affairs 647-1576.  Institutional Conflict of Interest - Clinical Trials Committee (ICOI-CT)  Reviews research conflicts that arise…

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Presentation on theme: "Office of Regulatory Affairs 647-1576.  Institutional Conflict of Interest - Clinical Trials Committee (ICOI-CT)  Reviews research conflicts that arise…"— Presentation transcript:

1 Office of Regulatory Affairs 647-1576

2  Institutional Conflict of Interest - Clinical Trials Committee (ICOI-CT)  Reviews research conflicts that arise… ◦ When the University holds equity, or, ◦ When a member of senior management has a significant financial interest in a UM start-up company.  Challenges—recognizing a start-up, long review time.

3  Starting September 1, all parties who must ‘accept their role’ in a study will be required to complete an M-Inform Disclosure.  Like all eResearch updates, amendments will be affected.  Non-faculty study team members will be new to M- Inform.  https://minform.it.umich.edu/ https://minform.it.umich.edu/

4 Outside Interests and Conflicts of Interest Team:  Ray Hutchinson, MD, Associate Dean for Regulatory Affairs, rhutchin@umich.edu, 615-1702 rhutchin@umich.edu  June Insco, OI/COI Manager ◦ insco@umich.edu, 615-9842 insco@umich.edu  Dana Dyderski, Regulatory Specialist ◦ dyderski@umich.edu, 615-4199 dyderski@umich.edu  Erin Beene, Regulatory Specialist ◦ ebeene@umich.edu, 764-0431 ebeene@umich.edu  Amy Spicer, Senior Administrative Assistant ◦ aspicer@umich.edu, 764-6730 aspicer@umich.edu

5  Industry-general term for biomedical companies; includes medical equipment, drug, and device manufacturers.  Vendor-any person or company from which UMHS buys services or supplies, e.g., drugs, devices, hot dogs, toilet paper, typing, lab work.  Outside Interest-a relationship you or your family members have (employment, ownership, contract) with a non-UM entity where that work or company is related to your UM work. ◦ NOTE: An outside interest does not necessarily create a conflict of interest.  Related-the work relies upon the same expertise you need to do your UM work, or UM buys products from your company, or you participate in purchasing decisions involving a company with which you or your family member has a relationship.

6 Conflict of Interest:  A situation where personal, professional, commercial, or financial interests or activities outside of UM have the possibility (either in actuality or in appearance) of: ◦ Compromising judgment; ◦ Biasing scholarly research; ◦ Influencing another’s decision or behavior; or, ◦ Resulting in a personal gain for you or your family member.

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