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COI Review: Committee Determination Process
There are three (3) COI Review processes:
- Initial Review
- Determination & Response to Management
- Annual Review
Only those situations considered to be a potential conflict of interest are sent to the COI Committee for final determination.
As a U-M employee, you participate in the Determination & Response process either as the conflicted individual or as someone with an oversight role (e.g., ombudsperson) when the committee determines that a conflict of interest requiring management exists.
When a potential personal, professional, commercial, or financial conflict of interest is identified, the appropriate U-M COI Committee (UMORCOI, MEDCOI) determines whether it could
unduly influence your primary obligations to science, sponsor, university, colleagues, or students.
Regardless of COI Committee determination, you will continue to disclose the outside interest in M-Inform on (at least) an annual basis, or within 30 days of changes, as long as the outside interest is active.
Determination of a Conflict of Interest Situation
If the determination is "no conflict"
The COI Committee determines that your relationship with the external entity does not meet the review criteria of a conflict of interest. The COI office notifies applicable central offices (i.e., ORSP, Office of Contract Administration, or U-M Innovation Partnerships) that U-M is authorized to proceed with the acceptance of the research award or agreement.
If the determination is "conflict exists: no formal management"
The COI Committee determines that there is minimal risk with the conflict situation. A COI Management Plan will not be drafted, but you are notified of any conditions for compliance, for example:
- Recusal from board decisions, purchasing decisions, etc.
- Disclosure of the conflict situation in publications or presentations
If the determination is "conflict exists: management required"
The COI Committee drafts a COI Management Plan for the specific conflict situation. The details of a management plan vary per the risk level of the conflict situation. Common management options include, but are not limited to:
- Disclosure of the existing conflict of interest by the conflicted individual in related publications or presentations, to students, study/project team members, oversight committees (e.g. IRB, IACUC), U-M Procurement Services, and sponsors of current research projects.
- Appointment of non-conflicted faculty to various roles (e.g., ombudsperson, PI on project, monitor for the project).
- Discontinuation of the conflict situation (e.g., end consulting agreement, divestiture of stock, etc.)
Individuals required to review and take action on a COI Management Plan include the:
- Conflicted individual (i.e., person with a conflict of interest)
- Ombudsperson(s) (if students or junior faculty are impacted)
- Monitor(s) (e.g., financial, scientific, data, etc.), if applicable
Responding to a COI Management Plan
All management plans are routed for review and action in M-Inform. There are two potential actions in M-Inform upon review of a draft COI Management Plan:
- Accept the draft management plan. This signifies that you agree to the plan and will follow its conditions. The conflict situation is considered active and "Under Management" once you and any ombudsperson and/or monitor (if applicable) accept the plan.
- Decline the management plan. This action is primarily used to communicate minor changes are required before acceptance of the plan occurs.
Declining the final COI Management Plan will result in the withdrawal of research proposals, sponsored awards, and/or agreements by the applicable central office.
If you, as a conflicted individual, disagree with the COI Committee's decision that a conflict of interest exists, you may appeal in writing to the Vice President for Research within 30 days of the notification of the committee's decision. The Vice President for Research will notify the petitioner and the applicable COI Committee of his/her final decision.