Office of Regulatory Affairs

 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.

 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. 

Outside Interests and Conflicts of Interest Team:  Ray Hutchinson, MD, Associate Dean for Regulatory Affairs,  June Insco, OI/COI Manager ◦  Dana Dyderski, Regulatory Specialist ◦  Erin Beene, Regulatory Specialist ◦  Amy Spicer, Senior Administrative Assistant ◦

 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.

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.