Conflict of Interest Review Process
There are two common avenues for identifying potential conflicts of interest related to sponsored research and technology transfer:
- During the processing of a sponsored project agreement, the PI will determine whether he/she and/or a key investigator or any family member of these individuals have a financial or management interest in the project sponsor or some other entity related to the project.
- During the disclosure of an invention and the develop of subsequent technology transfer agreements, it is determined that the inventor(s) or their family members have a financial or management interest in a company the University may wish to work with on the invention's development, manufacturing or marketing.
When either (1) or (2) identifies a potential conflict of interest, then a conflict of interest review is triggered. The basis for such a review is based on compliance with University Policy, Federal Regulation, or State Law.
- The PI (and all key investigators including UM students identified as having a conflict of interest in the sponsored project/technology transfer activities) must complete the UM Conflict of Interest Disclosure Form and submit it to the appropriate COI Committee. There are two COI committees on campus -- one covers the Medical School and the OVPR committee covers the rest of campus. [Download COI Disclosure Form]
- The appropriate Conflict of Interest Review Committee initiates a review of the disclosures submitted to them to determine whether the financial or management interests disclosed could directly and significantly affect the design, conduct, or reporting of the proposed project or technology transfer agreement. See "Overarching Principles" and "Operating Principles and Definitions" for additional insight into the review process and the basis for COI Committee decisions.
- Conflict of Interest Review Committee informs relevant parties of review determination & outcome.
If the committee decides that no conflict exists, it so notifies the appropriate parties (i.e., Project Director/Principal Investigator, Inventor), the unit head, and DRDA/OTT. DRDA/OTT is then authorized to proceed with acceptance of the project (upon notice of award by the funding agency) or technology transfer agreement.
If a conflict is deemed to exist, the committee designs a plan to manage the specific conflict situation. An appropriate management plan must be in place before the University will accept any sponsored award or technology transfer agreement in which a financial or management conflict is judged to exist. The relevant conflict of interest review committee will monitor any management plans established and, as part of that management, will require updates of disclosures from individuals involved in those management plans at least annually. The Key Investigators/Inventors may accept the management plan or seek modification by appealing in writing to the Vice President for Research (See below.) If the investigators do not accept the final management plan, DRDA (in the case of a sponsored project proposal) or OTT (in the case of a technology transfer agreement) will be instructed to withdraw the proposal/agreement.
Appeal Process
A decision by the Conflict of Interest Review Committee to halt the acceptance of a sponsored project or to withhold support for a technology transfer agreement because the conflict situation cannot be managed in an acceptable way may be appealed to the Vice President for Research within 30 days of the date the committee notifies the employee of the committee's decision.
Within 14 days of receipt of a written appeal, the Vice President for Research will decide either to endorse the committee's decision or to reverse the decision. The Vice President may impose conditions on the sponsored project or technology transfer arrangement before approval.
The Vice President will notify the petitioner and the COI committee of his/her decision.