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,

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

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?