Reviewing and Managing Institutional Conflicts of Interest
This procedure provides the framework for identifying and addressing institutional conflicts of interest, and describes the procedures employed in the following special situations:
- Human Participants Research
- Mission Related Commercial Transactions
I. Standard Process for Conflict Identification and Management
- Identifying Potential Conflicts of Interest
- University Officials and other individuals designated by president or delegate.These individuals complete a Financial Disclosure for University Officials form (FDUO) upon their appointment and annually thereafter, reporting both their own economic interests and affiliations and those of their family members (spouse, domestic partner, or dependent).
- Annual Reviews.Each year the Conflict of Interest (COI) Program requests information from the following entities in order to identify financial relationships the University has with business entities that could compromise the integrity of University research, teaching, outreach, and other mission-related activities:
- Office for Technology Commercialization:Information regarding (1) payments made by business entities in excess of $100,000 to the University in the prior fiscal year, to include the amounts paid to departments and faculty under the University’s revenue sharing principles set forth in the Board of Regents Policy: Commercialization of Intellectual Property Rights, and (2) the name of business entities (University startups) in which the University holds an equity interest pursuant to a license agreement.
- University of Minnesota Foundation: A list of business entities that donated gifts of $50,000 or more in the prior fiscal year and the University departments and administrative units that were recipients of those gifts.
- Purchasing Services: Information regarding vendor contracts with business entities in the prior fiscal year valued at $50,000 or more.
- Sponsored Projects Administration: Information regarding research sponsored by business entities during the prior fiscal year.
- Notice of University License or Option Agreements.The Office for Technology Commercialization notifies the COI Program when it executes a license or option agreement with a business entity whose commercial interests may be affected by research conducted at the University.
- Reviewing Potential Conflicts of Interest
- The COI Program evaluates the risk of an institutional conflict, either because of the financial or business interests of a University Official or because of the financial interests of the University, and consults with individuals and involved offices as appropriate.
- If there is little risk that the circumstances could affect University research, teaching, outreach or other mission-related activities, the COI Program notifies the University official or employee who submitted the disclosure that no further review or evaluation is required.
- If there is a risk that the circumstances could compromise or appear to compromise the integrity of the conduct or reporting of research, or other mission-related University activity, the COI Program refers the matter to the Institutional Conflict Review Executive Panel (“Executive Panel”). The University official or employee can participate in the conflict review and management process, to include appearing at an executive and/or full panel meeting.
- The Executive Panel decides either that no conflict exists or refers the matter to the full Institutional Conflict Review Panel for further consideration.
- The full Institutional Conflict Review Panel reviews the matter and determines whether a conflict of interest exists.
- Managing Conflicts of Interest
- If the Institutional Conflict Review Panel determines that a conflict of interest exists, the Panel identifies the steps necessary to address the conflict, to include managing, reducing, or eliminating the conflict, and conveys that information to the appropriate University official(s).
- If the Panel determines that a conflict management plan (CMP) is needed, the Panel also determines the mechanisms necessary to manage the conflict. The COI Program staff drafts the plan and provides it to the University official or employee for review and acceptance. If there are substantive concerns with the plan the matter is returned to the full Panel. If the parties cannot reach agreement on a plan, the COI Program will notify the individual's supervisor that the individual has an unmanaged conflict of interest.
- The Chief Compliance Officer and the General Counsel evaluate whether the conflict management plan requires Regents' approval. Under Board of Regents policy: Institutional Conflict of Interest, Regents approval is required if the conflict of interest involves:
- external relationships with an unusually significant financial impact;
- conflicts involving the president;
- conflicts that raise serious policy issues or have a significant public impact on the University's mission or reputation; or
- conflicts arising in matters that otherwise require Board review and action under Board of Regents Policy: Reservation and Delegation of Authority.
- Implementing the Conflict Management Plan
Once the Institutional Conflict Review Panel or Regents approve the CMP, the appropriate University official implements it.
- Oversight of the Conflict Management Plan
The Institutional Conflict Review Panel, with the assistance of the Conflict of Interest Program staff, verifies compliance with the management plan at least annually and addresses any issues that arise.
II. Special Situations
- Human Participants Research Involving More Than Minimal Risk
- When a unit within the University proposes to evaluate an invention in which the University has a financial interest under the terms of a University licensing agreement, and the evaluation is determined by the Institutional Review Board to involve "more than minimal" risk to human participants, the COI staff and Executive Panel will gather information for consideration by the full Institutional Conflict Review Panel.
- In assessing and managing potential institutional conflicts of interest involving human participants research, the Institutional Conflict Review Panel (ICRP) presumes that the research should not be conducted at the University unless there are compelling circumstances that justify proceeding with the research here despite the institutional conflict.
- The ICRP may approve conducting the research at or under the auspices of the University if it determines, based on a fact specific inquiry, that compelling circumstances are present, and that an effective conflict management plan can be implemented to protect the welfare of human participants and the integrity of the University’s research. Whether the circumstances are “compelling” will depend in each case upon an analysis of:
- The nature of the research, including current phase of development and intentions for subsequent phases;
- The nature of the financial interest;
- The degree to which the University and its employees stand to benefit financially from the research;
- How closely the financial interest is related to the research and the degree to which the financial interests may be affected by the research;
- The degree to which the conflict can be effectively managed;
- The magnitude of risk to human participants inherent in the research and the ability of the University to appropriately safeguard the welfare of the human research participants; and
- Whether the University is uniquely qualified, by virtue of distinctive resources (e.g. special facilities or equipment, unique patient population) and the experience and expertise of its investigators, to conduct the research and appropriately safeguard the welfare of the human research participants involved.
- If the ICRP approves conducting the research at the University and determines that a CMP is required, it will coordinate its work with the Institutional Review Board (IRB), which has final authority to determine whether the CMP adequately protects research participants such that the research may proceed.
- The University manages potential conflicts of interest related to investments by segregating the decision-making for investment transactions from the decision-making for University research, teaching and outreach activities. Under Regents policies, outside professional asset management firms independent of the University manage the University's endowment and investment portfolios and determine when to buy and sell stock and other holdings on behalf of the University. See Board of Regents Policies:
- This mechanism provides sufficient separation and independence between the University's investment decisions and its research, teaching and outreach activities to adequately minimize the risk that an institutional conflict of interest will arise.
- Mission Related Commercial Transactions
- The General Counsel will assess whether there is potential for an institutional conflict of interest prior to entering into substantive discussions or making an oral or written commitment regarding a commercial transaction that has a value greater than $2M, appears to have a significant impact on the University’s mission or raises unusual questions of public interest or public policy.
- If the General Counsel determines that the transaction may compromise or appear to compromise the University’s research, teaching, or outreach mission activities, or its institutional reputation, the General Counsel will inform the appropriate executive decision-maker and the Director of the University's Conflict of Interest Program and refer the matter to an ad hoc committee for review.
- The ad hoc review committee, assembled by the General Counsel, will consist of relevant academic and administrative officers, identified by the President or designee, and one or two members of the University's Institutional Conflict Review Panel, as recommended by the Chair of the Panel. The committee will identify issues that need to be considered in the decision-making process and offer a perspective on those issues. The input of the ad hoc review committee will be advisory in nature, and not binding.
- The General Counsel and the appropriate executive decision-maker will share the input of the ad hoc review committee with the President and determine how to proceed, subject to a final decision by the President or the Board pursuant to Board of Regents Policy: Institutional Conflict of Interest.