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U-M ICOI Partners
Various university offices partner with the ICOI committee to identify potential institutional conflicts of interest and provide input for committee determinations, including but not limited to:
- Office of the President
- Office of Research and Sponsored Programs (ORSP)
- Office of Technology Transfer (OTT)
- Office of University Development
- Office of the Vice President for Communications
- UMOR Research Ethics and Compliance Office
- Medical School Regulatory Affairs Office
- Michigan Medicine Corporate Compliance Office
The University of Michigan identifies an institutional conflict of interest (ICOI) as:
a situation in which a financial interest of the university (e.g., investments held by the university in a company) or a Covered Official has the potential to bias, or appear to bias, research conducted by its employees or students.
About the ICOI Research Compliance Program
U-M follows the Office of the President's Policy for Institutional Conflicts of Interest in Research, which governs the identification, review, and management of potential institutional financial conflicts of interests. The university's ICOI program provides the operational oversight and the procedural structure for the Institutional Conflict of Interest Committee (ICOI Committee) to implement and maintain the U-M ICOI policy.
Potential ICOI Situations
Institutional financial interests can be created by gifts, payments, royalty income, or other financial benefits provided to the university from for-profit entities or from equity interest held by the university in the entities. Examples of institutional financial interests include:
- Payments resulting from the transfer (licensing) of technology created at the university to an entity, including royalties, milestone payments, and other licensing fees;
- Equity in (i.e., ownership of) a company (publicly or non-publicly traded) resulting from the transfer of university technology or from direct investment;
- Gifts, including gifts-in-kind of goods or services, from a potential sponsor (i.e., a commercial company), from a philanthropic unit of the sponsor, or from an individual affiliated with a sponsor; and
- Covered Official relationships where an institutional official receives payments, honoraria, royalties (including those from U-M), equity, options and warrants, company positions (e.g., board directorships and/or management), or gifts.
A potential ICOI situation arises when the company also sponsors research at the university or manufactures products to be studied or tested at U-M or under its auspices.
Financial interests of the university must be identified, disclosed, and reviewed to prevent or manage institutional conflicts of interest that may affect (or reasonably appear to affect) institutional processes for the design, conduct, reporting, review, or oversight of research.
The ICOI Committee reviews notifications of potential institutional conflicts from its U-M partner offices (see blue box above) to identify if an ICOI exists and to determine appropriate management, which may include reducing or eliminating the ICOI. As part of its review, the ICOI Committee may consider:
- Disclosures of individual investigators, and
- Whether the institutional financial interest has the potential to affect, or appear to affect:
- The responsible conduct of research including, the safety of human subjects, the appropriate use of research animals, and the safe conduct of research involving hazards;
- Research integrity;
- The appropriate allocation of university resources;
- The dissemination of research results;
- Related educational activities, including non-exploitation of students or trainees;
- Managing and licensing intellectual property resulting from research activity; or
- The independence of professional practice judgment.
In addition, the ICOI Committee acts in an advisory role for non-research related conflicts of interest.
The ICOI Committee is managed by the UMOR COI Office in conjunction with the MEDCOI Office. The ICOI Committee will meet on a monthly basis throughout the year.
ICOI management strategies include, but are not limited to:
- Permitting the research to proceed, subject to a plan for managing the ICOI and any personal conflicts of interest (COI);
- Permitting the research to proceed, with divestiture of the financial interests of the university and individual investigators; or
- Prohibiting the research from taking place at the university.
Roles & Responsibilities
As a U-M employee, you are expected to comply with the university's ICOI policy. Should an ICOI situation exists for a company that sponsors your research, you will be notified by the ICOI Committee and you will be expected to review and take action on the ICOI management plan. This may include disclosing the university's financial interest to the study team, in publications, and/or in informed consent documentation.
A Covered Official of the University is an executive officer, dean, or institute/center director with day-to-day responsibility for the supervision of faculty and staff participating in research conducted at or under the auspices of the University.
Conflicts of Interest (COI) represent financial or other situations where an individual has an outside interest (e.g., equity in a company, intellectual property, consultant activity with a company) that could affect the design, conduct or reporting of their research. Also refered to as personal or individual COI.
Institutional conflicts of interest (ICOI) represent financial or other situations where the University, as an institution, has an outside interest (e.g., equity in a company doing business with the University) that could affect the design, conduct, reporting, review or oversight of research conducted by its employees or students.