Office of Regulatory Affairs 647-1576. Institutional Conflict of Interest - Clinical Trials...
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Transcript of Office of Regulatory Affairs 647-1576. Institutional Conflict of Interest - Clinical Trials...
Conflict of Interests—What’s New and Coming
Office of Regulatory Affairs647-1576
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.
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
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/
M-Inform & eResearch RM
Outside Interests and Conflicts of Interest Team: Ray Hutchinson, MD, Associate Dean for Regulatory Affairs,
[email protected], 615-1702 June Insco, OI/COI Manager
◦ [email protected], 615-9842 Dana Dyderski, Regulatory Specialist
◦ [email protected], 615-4199 Erin Beene, Regulatory Specialist
◦ [email protected], 764-0431 Amy Spicer, Senior Administrative Assistant
◦ [email protected], 764-6730
Office of Regulatory Affairs
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.
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.
Definitions
Q&A
HUH?