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Conflict of Interests— What’s New and Coming

Conflict of Interests— What’s New and Coming. Office of Regulatory Affairs 647-1576. Policy on Institutional Conflict of Interest in Clinical Trials of Drugs, Devices, or Biologics Supported by University Start-up Companies http://orsp.umich.edu/policies/um/coi/ICOIpolicy.html.

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Conflict of Interests— What’s New and Coming

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  1. Conflict of Interests—What’s New and Coming Office of Regulatory Affairs 647-1576

  2. Policy on Institutional Conflict of Interest in Clinical Trials of Drugs, Devices, or Biologics Supported by University Start-up Companieshttp://orsp.umich.edu/policies/um/coi/ICOIpolicy.html • 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. M-Inform & eResearch RM • 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/

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

  5. Definitions • 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. Definitions 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.

  7. Q&A Huh?

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