Institutional Conflict of Interest

Institutional Conflict of Interest in Human Subjects Research

 

Effective January 1, 2016, the University of Iowa’s Institutional Conflict of Interest in Human Subjects Research Policy became operational as a result of Human Subjects Research Accreditation standards.

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.

Unlike the Conflict of Interest in Research Policy, this policy requires University officials to disclose all financial interests, regardless of relatedness to his or her University responsibilities, in the eCOI disclosure portal. These interests are to be reported because a University official acting within his or her authority on behalf of the institution, 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.

"University Official" includes all individuals in the following roles:

  • University President
  • Provost
  • Vice Presidents
  • Associate Provost
  • Associate Vice Presidents
  • Treasurer
  • Controller
  • Deans
  • Associate and Assistant Deans
  • Departmental Executive Officers
  • Heads of Regental Centers and Institutes

University officials should report the following interests:

  • Royalties or other payments from licenses or other technology transfer agreements related to University intellectual property rights from a for-profit company
  • Payments (e.g. salary, consulting fees, honoraria, gifts, etc.) received from a for-profit company
  • Any equity or other ownership in a non-publicly traded company
  • Any position giving rise to a fiduciary duty in a for-profit company

The University of Iowa, as an institution, may also have significant financial interests. These financial interests include:

  • Royalties or other payments from licenses or other technology transfer agreements related to University intellectual property rights from a for-profit company
  • Gifts/gifts-in-kind and donations received from a for-profit company
  • Equity or ownership interest (other than a mutual fund) in a publicly traded company
  • Any equity interest or an entitlement to equity of any value, including options or warrants, in a non-publicly traded company

These interests will be reported to the Conflict of Interest in Research Office by the University of Iowa Research Foundation and the University of Iowa Foundation. This data will also be entered into the eCOI disclosure system by the Conflict of Interest in Research staff.

While this policy is under the authority of the Office of the President, administrative aspects of this policy will be carried out by the Conflict of Interest in Research Office. This means that the Conflict of Interest in Research Office will collect and assess financial interest disclosures submitted in the eCOI portal. Assessment includes determining if a reported financial interest reaches certain thresholds and creates a significant financial interest, and then whether or not that significant financial interest is related to human subjects research that is being conducted at the University of Iowa.

The Conflict of Interest in Research Office determines, with the consultation of the Conflict of Interest in Research Officer, whether or not an institutional conflict of interest in human subjects research exists. If the interest exists with a University official, that official will be asked to recuse him/herself from all business decision related to the interest, or to divest from the interest. If neither of these are practical options, then the institutional conflict of interest in research committee will review the case and determine a) if the interest can reasonably be managed, and if so, b) recommend management strategies to mitigate the impact of the interest on the research. In the case of a financial interest held by the University itself, the case will go directly to the committee where the same determinations will be made.

The institutional conflict of interest committee is comprised of the Conflict of Interest in Research Committee plus two additional members – the President or his/her designee and an unaffiliated member of the greater community.

For additional information, please consult the Institutional Conflict of Interest in Human Subjects Research Policy. For questions, please contact Martha Hedberg, COI Specialist, at 384-4256 or Martha-hedberg@uiowa.edu.