Printed on: 12/15/2018. Please go to http://policy.umn.edu for the most current version of the Policy or related document.
Procedure

Evaluating Reports of Business and Financial Interests and Managing Individual Conflicts of Interest

Administrative Procedure

A. Evaluating Reports of External Professional Activities (REPA)

  1. Administrative Review in Academic and Administrative Units
    1. Chancellors, deans, and administrative unit heads are responsible for the REPA review process conducted in their respective organizations, but they may delegate primary approval responsibilities to an appropriate subordinate.
    2. Designated approvers/reviewers are encouraged to designate alternate approvers.
    3. To help ensure that conflicts of interest are identified and managed in a timely fashion, individuals charged with reviewing REPAs must conduct the reviews in a timely fashion.
    4. Designated approvers/reviewers will approve the REPA, return the REPA for more information, or refer the REPA to the COI Program for further review.
  2. Administrative Review by the COI Program
    1. COI Program staff review a referred REPA to determine if additional information is needed from the covered individual.
    2. If, following a review of all relevant information, COI Program staff determines that no conflict of interest exists, the REPA is approved by the COI Program staff and no further action is required.
    3. If COI Program staff conclude that a potential conflict of interest exists, the matter is referred to the appropriate Conflict Review Panel (CRP) for review.

B. Managing Conflicts of Interest

  1. Role of the Conflict Review Panel
    1. Executive Conflict Review Panel. Performs the initial review of matters referred by the COI Program staff. Refers potential conflict of interest matters to a full CRP.
    2. Full Conflict Review Panel. The full CRP is charged with making conflict of interest determinations, and determining the mechanisms required to manage conflicts under a written conflict management plan.
  2. Role of the Covered Individual

    1. The covered individual can participate in the conflict review and management process, to include appearing at an executive and/or full panel meeting.
    2. Within two weeks of receipt of a draft conflict management plan, communicates acceptance of the plan or concerns about the plan to the COI Program. If the parties cannot reach agreement on a plan, the COI Program will notify the covered individual's unit head, or dean or vice president that the covered individual has an unmanaged conflict of interest.
  3. Special Considerations
    1. PHS funded research conflicts
      1. Conflict management plans must be developed and implemented prior to the University’s expenditure of funds under a PHS-funded research project. After the conflict management plan is implemented, the University’s Sponsored Projects Administration shall provide an FCOI report prepared by the COI Program to the PHS Awarding Component prior to the University’s expenditure of funds.     
      2. When a new investigator is added to an on-going PHS funded research project, or when an existing investigator discloses a new significant financial or business interest, the COI Program must review the disclosure and, if a conflict of interest exists, implement a conflict management plan on at least an interim basis and submit an FCOI report to the PHS Awarding Component within sixty days of the disclosure. Depending on the nature of the significant financial interest, the COI Program may determine that additional interim measures are necessary with regard to the investigator’s participation in the PHS-funded research project between the date of disclosure and the completion of the conflict review.
      3. For the duration of any PHS-funded research project (including extensions with or without funds) in which a financial conflict of interest has been previously reported by the University, the Sponsored Projects Administration shall obtain an update on the financial conflict of interest and any changes to the management plan from the COI Program and provide to the PHS Awarding Component an annual FCOI report that specifies whether the conflict is still being managed or why the conflict no longer exists.
    2. Human Participant Research
      1. Investigators who participate in an open human participant research study requiring IRB approval and oversight that is sponsored by a company, or involves the development or evaluation of a company’s product, device, or other technology, may provide consulting or speaking services (“services”) for the company during the period of the research study under the following conditions:
        • Any payments made in exchange for the services are directed to the University under the terms of a University External Sales Agreement;
        • The funds are not used to support the salary of the investigator;
        • The arrangement is approved by a Conflict Review Panel.

          For purposes of this provision, a human participant research study is open from the time the study is approved by the IRB until participant enrollment is closed and the primary outcome from the study has been published.

          Investigators may receive study-related expenses as approved in the University budget for the study, including salary support and travel expenses.

          An investigator may request that the Conflict Review Panel approve an exception to this provision in order to receive personal remuneration or equity from the company while participating in the study. Compelling circumstances must be present to warrant approval of the exception.  

      2. Where human participants research involving more than minimal risk to the participants is involved, the circumstances are reviewed with greater scrutiny to ensure that the welfare of human participants will not be compromised by the existence of a business or significant financial interest. Absent compelling circumstances, conflicted researchers are not permitted to serve as PI for a human participant study determined by the IRB to pose more than minimal risk to participants.
    3. Clinical Trials. The CRP evaluates, among other issues, whether the conflicted covered individual may participate in any of the following activities:
      1. subject recruitment;
      2. subject selection, including prescreening for inclusion/exclusion criteria;
      3. consent process; or
      4. clinical treatment of participants, separate from the research interventions or procedures, including adverse event evaluation and reporting.

C. Conflict Management Plan Compliance Reviews

  1. Ninety Day and Annual Reviews.

    COI Program staff conduct compliance reviews 90 days after the establishment of a CMP, and annually until the conflict of interest forming the basis of the plan no longer exists.

  2. Documentation Required.

    As part of the CMP follow-up covered individuals may be asked to provide evidence of disclosures required under the plan.  Additionally, if a plan requires research oversight the COI Program will request the submission of the oversight report.

D. Enforcement

Failing to follow an approved CMP may subject a covered individual to discipline. If sanctions are necessary, they will be imposed in accordance with other applicable Board of Regents and administrative policies and procedures.

To the extent required by a research sponsor, the Vice President for Research or designee will notify the research sponsor of the violation and any corrective action taken or to be taken.  In the case of PHS-funded research, if the failure of an investigator to comply with the University’s Conflict of Interest Policy or a conflict management plan appears to have biased the design, conduct, or reporting of the research, the PHS Awarding Component will be notified promptly of the action taken or to be taken.

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