18.7 Institutional Conflict of Interest in Human Subjects Research

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  1. Policy. As a steward of the public trust, The University of Iowa is obligated to ensure its research involving human subjects is carried out with integrity, open inquiry, and rigorous analysis, free from potential financial conflicts of interest that might affect the sound judgment of its faculty, staff, and students. When financial interests of the University or its University officials exist and create real or potential bias to the outcome of its research, an institutional conflict of interest exists. For example, the University or one of its officials may have a financial interest in a company sponsoring research covered by this policy or may hold a proprietary interest in a product that is the subject of the research. When such research involves human subjects and the institution maintains its financial interest, the conflict of interest is presumed to be unacceptable. Such research will only be allowed to proceed at the University if there are compelling circumstances justifying the research to be conducted despite the presence of the financial conflict.
  2. Scope of policy.
    1. This policy applies to significant financial and fiduciary interests of the institution or those of its University officials where such interests or activities are related to human research studies designed to answer questions about the effects or impact of a particular drug, treatment, or diagnostic/therapeutic device.
    2. This policy does not require the University to refrain from conducting business with companies which have financial relationships with the University and also sponsor human subjects research, but such relationships must be appropriately managed by making reasonable efforts to address potential conflicting interests prior to finalization of the proposed University transaction (e.g., prior to the gift, contract, or sponsored project being executed or accepted) that may give rise to a potential institutional conflict of interest (ICOI).
    3. It is the policy of the University to address institutional conflicts of interest (ICOIs) held by the University and/or its University officials through disclosure, review, elimination, or, where appropriate, management to avoid all such conflicts that are contrary to its mission as a public institution of higher education.
  3. Oversight and administration of the policy. This policy is under the oversight of the Office of the President, which will appoint both an Institutional Conflict of Interest Officer and an Institutional Conflict of Interest Committee to carry out the functions specified in this policy. Administrative aspects of this policy will be carried out by the Conflict of Interest in Research Office. For matters relating to this policy, the Institutional Conflict of Interest Officer and Committee will report directly to the President or his or her designee.
  4. Definitions.
    1. "Institutional conflict of interest" means financial interests of the University as an institution or of a University official acting within his or her authority on behalf of the institution, that could directly and significantly affect, or reasonably appear to directly and significantly affect, institutional processes for the design, conduct, reporting, review, or oversight of human subjects research that is designed to answer questions about the effects or impact of particular drugs, treatments, or diagnostic/therapeutic devices.
    2. "University official" includes the following individuals who, because of their respective positions with the University, have the capacity to affect, or can reasonably appear to affect, University processes for the design, conduct, reporting, review, or oversight of human subject research: the University President, provost, vice presidents, associate provosts, associate vice presidents, treasurer, controller, deans, associate and assistant deans, departmental executive officers, and the heads of centers and institutes.
    3. "Institutional oversight committees" means University committees that make decisions or recommendations regarding human subject research covered by this policy (e.g., the Institutional Review Board, the Conflict of Interest in Research Committee, and other ancillary review committees). Members are required by conflict of interest policies specific to those committees to recuse themselves from the review in the event of a conflict of interest.
    4. "University" means The University of Iowa, any of its major units, and any of its affiliated organizations as that term is defined in University policy in I-4 Affiliated Organizations.
    5. "Significant financial interest" is an interest held by or on behalf of the institution or a University official (including the University official's immediate family, individually or in aggregate) and defined below:
      1. In the case of the institution, "significant financial interest" means:
        1. Royalties or other payments from licenses or other technology transfer agreements related to University intellectual property rights, when such payments are in excess of $100,000 and received within the past 12 months from a for-profit company supporting or proposing to support a sponsored project/activity that falls within the scope of this policy;
        2. Gifts/gifts-in-kind and donations in excess of $100,000 received within the past twelve months from a for-profit company supporting or proposing to support a sponsored project/activity that falls within the scope of this policy;
        3. Through technology licensing activities or investments related to such activities, the University has obtained an equity or ownership interest (other than a mutual fund) in a publicly traded company worth more than $100,000 as determined by reference to publicly listed prices, received within the past 12 months from a for-profit company supporting or proposing to support a sponsored project/activity that falls within the scope of this policy; or
        4. Any equity interest or an entitlement to equity of any value, including options or warrants, in a nonpublicly traded company whose value cannot be determined by reference to publicly listed prices (i.e., equity interest in a start-up company) and which is supporting or proposing to support a sponsored project/activity that falls within the scope of this policy.
      2. In the case of a University official, "significant financial interest" means:
        1. Royalties from licenses or other technology transfer agreements related to University intellectual property rights, when such payments are in excess of $25,000 and received within the past 12 months from a for-profit company supporting or proposing to support a sponsored project/activity that falls within the scope of this policy;
        2. Payments, e.g., salary, consulting fees, honoraria, or gifts, in excess of $25,000 and received within the past twelve months from a for-profit company supporting or proposing to support a sponsored project/activity that falls within the scope of this policy;
        3. Any equity or other ownership interest in a nonpublicly traded company supporting or proposing to support a sponsored project/activity that falls within the scope of this policy;
        4. A position giving rise to a fiduciary duty in a for-profit company supporting or proposing to support a sponsored project/activity that falls within the scope of this policy.
  5. Disclosure and review of significant institutional financial interests.
    1. Disclosure of interests.
      1. Interests held by the University. The Conflict of Interest in Research Office will receive on a monthly basis the following information:
        1. A list from the UI Research Foundation that includes companies that have business relationships with the University that include licensing agreements; patents; invention disclosures; royalty payments; and University ownership and/or equity interests and payment distributions.
        2. A list from the UI Foundation of corporate donors that gave gifts/gifts-in-kind in excess of $100,000, including an indication, where known, how such gifts/gifts-in-kind are to be used to support sponsored projects/activities that fall within this policy. The list will also contain the names of those University departments and/or individuals who were recipients of disclosed gifts.
      2. Interests held by University officials. All University employees who meet the definition of University official under this policy are required to complete an online Annual Report of Outside Professional Activities and Interests for the previous calendar year by April 30 of each year and within 30 days of an event that requires disclosure.
    2. Review of significant financial interests.
      1. In consultation, when needed, with the chair of the ICOI Committee, the Office of General Counsel, and the UI Research Foundation and/or UI Foundation, the Institutional Conflict of Interest in Research Officer/Office shall be responsible for reviewing all disclosed financial interests to determine if the financial interests 1) exceed the thresholds in paragraph d(5) above; 2) is related to the research; and 3) can be directly and significantly affected by the outcome of the research. If these three conditions are met, the financial interest is deemed to be an institutional conflict of interest (ICOI).
      2. In the case of an ICOI held by the institution, the identified ICOI is referred to the Institutional Conflict of Interest Committee.
      3. In the case of an ICOI held by a University official, the ICOI Officer shall notify the University official that he or she must recuse her- or himself from any business decision, allocation of University resources or personnel, oversight or approval process that involves a company with which he or she has an ICOI that is conducting human subject research covered under this policy. If recusal is not possible in order to carry out her or his University obligations, she or he must divest the ICOI. If the University official does not wish to take the divestment route, the identified ICOI is referred to the ICOI Committee.
    3. Institutional Conflict of Interest (ICOI) Committee Review.
      1. An ICOI Committee will be established by the President or designee to consider matters referred to it in accordance with this policy and comprised of members of the Conflict of Interest in Research Committee (CIRC), with the President's designee serving as chair and at least one unaffiliated (non-University) member from the community. CIRC membership consists of faculty representation from the University colleges.
      2. This policy presumes that the University will not conduct research in the presence of an Institutional Conflict of Interest. In the event the ICOI is not eliminated, this presumption can only be rebutted where a compelling justification is presented for waiver of this policy and where an effective management plan can be implemented to fully protect human subjects and the integrity of the research.
      3. When proposing to conduct human subjects research for which an institutional conflict of interest exists, the principal investigator (PI) shall be responsible for preparing and submitting to the ICOI committee a detailed explanation of the compelling circumstances that justify allowing the research to be conducted under the auspices of the University. The PI should address specifically the following elements:
        1. A description of the research, including its current phase of development and intentions for subsequent phases;
        2. The degree of risk posed by the ICOI to participants in the research; and
        3. The existence of unique circumstances that would require that the research be performed at the University as opposed to another site, such as unique qualifications of the investigator and/or unique resources/capabilities of the University. The rebuttable presumption/compelling justification standard is intended to be a high bar, not readily overcome.
      4. Where the ICOI Committee determines that compelling circumstances exist to allow the research to proceed in the presence of an ICOI, the following additional criteria should be considered when evaluating an ICOI:
        1. Size and nature of the financial interest or relationship held by the University and/or University official;
        2. How closely the interest is related to the research, and whether the interest could be directly and substantially affected by the research.
      5. If the ICOI Committee determines there are compelling circumstances for allowing the research to proceed in the presence of an ICOI, the research will be subject to stringent and effective management measures in order to provide for the safety of the human participants and the integrity of the research. The management plan will be based on a risk-benefit analysis that balances the potential benefits of the project and the institution's participation in it with the risks to subjects, risks to integrity of research data, risks of bias, and risks of the appearance of an ICOI.
      6. In developing case-specific management plans, the ICOI Committee may at its discretion include one or more of the following management strategies among any others it may devise:
        1. Disclosure of the ICOI in the informed consent processes;
        2. Use of an external Institutional Review Board;
        3. Use of an independent study monitor, Data Safety Monitoring Board (DSMB), or external reviewer;
        4. Disclosure of the ICOI to the other research centers in a multicenter trial;
        5. In cases where an ICOI involves a University official, the following should be considered:
          1. Whether the University official's authority over the research and/or the people involved in its performance can be effectively and practically managed while the University official remains in the assigned leadership position;
          2. Whether the University official should be recused from decisions affecting the research, including but not limited to decisions over salary, promotion, and space allocations affecting the investigator;
          3. The designation of a "safe haven" (e.g., a nonconflicted senior individual) with whom the investigator can address ICOI concerns.
        6. Disclosure of the ICOI by the principal investigator in presentations and publications and to all research team members.
        7. Disclosure to sponsor of the research as required by the sponsor and all applicable regulations and laws.
      7. The ICOI Committee will provide its written recommendations for management to the President or his or her designee. The committee will state specifically who will be responsible for the plan's implementation and monitoring. The content and approval of the final management plan rests with the President or his or her designee.
  6. Process for appeal. Any person negatively affected by any decision by the President under this policy may appeal to the Board of Regents, State of Iowa.