KUMC Management of Institutional Conflicts of Interest
To outline the process for review and management of Institutional Conflicts of Interest.
University of Kansas Medical Center, KU Medical Center Research institute, Inc.
KUMC strives to assure that its research and other activities are not compromised or perceived as biased by financial and business considerations. Examples of Institutional Conflicts of Interest that could occur include, but are not limited to situations in which:
- A University Official with a business or significant financial interest in a business entity is in a position to take action on behalf of KUMC that may benefit or be perceived to benefit the business entity.
- KU Innovation & Collaboration (“KUIC”) licenses an invention to a business entity and holds royalty or equity interests in the entity that may be affected by ongoing KUMC research or other KUMC activities.
- KUMC or the University engages in a commercial transaction that compromises or appears to compromise KUMC’s activities.
- The University or one of its controlled affiliated entities has a business or significant financial interest in a business entity whose commercial interests may be affected by research conducted at KUMC.
- The University has received substantial gifts from a potential commercial sponsor of research or a company that owns or controls products being studied or tested.
1. Notification of Financial Interests by KUIC. When KUIC takes an equity interest in a company or enters into a license agreement with a company, the Director, Technology Transfer, or his or her designee shall provide the KUMC Conflict of Interest Manager (“COI Manager”), the Human Research Protection Program and the KUMCRI Office of Legal Affairs with information regarding such interest or license. Updates regarding all current equity interests and license agreements held by KUIC shall be provided to the Institutional Conflict of Interest Committee on a regular basis.
2. Notification by KUMCRI or KUIC of Contracts and Grants involving Institutional Financial Interests. Prior to entering into a research contract or grant with a company in which KUIC holds an equity interest, and prior to commencing a research project dealing with a company in which KUIC holds an equity interest or receives royalty payments, the individual negotiating the contract on behalf of KUIC or KUMCRI as the case may be (e.g., the KUMCRI contract negotiator for research grants or the KUIC contract negotiator for industry agreements) shall notify the COI Manager. The COI Manager will refer the matter to the KUMC Institutional Conflict of Interest Committee for review, and will notify the PI, the department chair or director, the Dean of the school and the Vice Chancellor for Research of such referral.
3. Notification by the PI. The Principal Investigator is required to notify the applicable Institutional Review Board, IACUC and/or the other applicable oversight boards (e.g., IBC) if a study involves a University licensed technology or if the Principal Investigator is aware that KUIC holds a royalty or equity interests in an entity that may be affected by the KUMC research.
4. Financial Interests of University Officials. University Officials are required to disclose their financial interests, and the financial interests of their family members, in accordance with KUMC’s Conflict of Interest Policies and Procedures. The Conflict of Interest Program within the KUMC Office of Compliance is responsible for reviewing the financial disclosures of University Officials. If a potential Institutional Conflict of Interest is identified, the matter will be referred to the Institutional Conflict of Interest Committee, which will conduct a review and determine whether the potential Institutional Conflict of Interest should be managed, reduced or eliminated. The Institutional Conflict of Interest Committee should review the University Official’s role in relation to the research and to the researchers, the nature of the University Official's conflict of interest, and the extent to which an appearance of bias could result. The committee should then formulate a plan so that, if deemed appropriate, an alternative University Official can oversee the research for KUMC. In most cases alternative supervision can be arranged. As a result, in such a situation, there is no "rebuttable presumption" that the work cannot be performed at KUMC.
5. Investments and Research.
a. KUMC relies upon the separation of functions and administrative responsibilities related to research from those related to investment of institutional funds, to further minimize the risk that institutional conflict of interest will arise. Effective July 1, 2008, equity accepted when licensing University technology shall only be held by KUIC. Where authority exists to invest KUMC funds, the investment decisions reside with the Office of Business and Financial Planning and is subject to the limitations of state law and Kansas Board of Regents policy. Individuals responsible for managing the investments of KUIC, KUMCRI, and the Office of Business and Financial Planning will not communicate with The Kansas University Endowment Association (“KU Endowment Association”), KUMC officials or researchers concerning the conduct and interpretation of ongoing or planned research performed at KUMC for the purpose of influencing investment decisions of the institution, KU Endowment Association, KUIC or KUMCRI.
b. Certain endowments and funds that exist for the benefit of the University and its affiliates are owned or managed by the KU Endowment Association, an independent nonprofit organization which raises and manages funds for the benefit of the University. KU Endowment Association is not a controlled affiliate of the University. The University has no power to make appointments of the members of, or to vote on any position or proposal before, the KU Endowment Association Executive Committee or its Trustees. KU Endowment Association does not give the University, KUMCRI or KUIC information concerning the identities of companies in which KU Endowment Association makes investments. KUMCRI and KUIC do not give KU Endowment information concerning the identities of entities in which KUIC has an equity interest or with which KUIC has a license agreement for University technology.
6. Review by the Institutional Conflict of Interest Committee.
c. Study Design. When considering the need for a study-specific management plan, the Institutional Conflict of Interest Committee will review whether the study has been designed to minimize researcher discretion in interpreting results. The researcher shall keep extensive notes to detail results and other issues that come up during the study.
d. External Oversight. The Committee will also consider the desirability of contracting with an external IRB or IACUC to provide a second level of review and oversight. Management plans will include a statement regarding the required disclosures (if any) of the financial interest.
e. Rebuttable Presumption regarding Human Research. When reviewing any of the circumstances that may create, or appear to create, institutional conflicts of interest in research, the Institutional Conflict of Interest Committee shall apply a rebuttable presumption against conduct of the research at, or under the auspices of, KUMC. The presumption may be rebutted when the circumstances are compelling and the committee has approved an effective management plan. Whether or not the committee deems the circumstances to be compelling will depend upon the nature of the science, the degree of risk that the research poses to subjects, and the degree to which the interests may be affected by the research, whether or not KUMC is uniquely qualified, by virtue of its attributes (e.g. special facilities, equipment, unique patient populations) and the experience and expertise of its investigators, to conduct the research and safeguard the welfare of the subjects involved. Even when the institution is deemed uniquely qualified, conflicts associated with significant risk to human subjects should be avoided whenever possible and, if permitted, will be closely managed.
f. Multi-Center Clinical Trials. When an Institutional Conflict of Interest cannot or will not be eliminated through recusal or otherwise managed, the presumption should be that KUMC will not conduct related clinical research except as the non-primary site in a multi-center trial. Even when participating as a non-primary site in a multi-center trial, KUMC should not serve as the coordinating site unless the possible Institutional Conflict of Interest has been managed.
g. External Monitoring of Single/Primary Site Trials. Serving as the sole or primary performance site for a clinical trial may be justified under compelling circumstances (e.g. when the research is an early-stage or feasibility trial and the expertise of institutional investigators is essential to the research). In such a case, however, the Institutional Conflict of Interest Committee should approve the circumstances, and if advisable, the research should be subject to monitoring by an oversight body with external members, such as a data and safety monitoring board.
7. Communication of Management Plans to the IRB. Determinations by the Institutional Conflict of Interest Committee relating to study involving human subjects research, and copies of any resulting management plan, will be provided by the COI Manager to the Director of the KUMC Human Research Protection Program for consideration by the applicable IRB. Nothing shall prevent the IRB from requiring additional or more stringent management requirements, or from denying approval of a specific study in accordance with applicable IRB requirements.
8. Monitoring of Management Plans. The Vice Chancellor for Administration or his or her designee shall be responsible for monitoring the situation through a management plan, with special attention to resource allocation, employment practices, and graduate student assignments, and for informing the researcher.
Associate Vice Chancellor, Compliance
University of Kansas Medical Center
Mail Stop #7004
Kansas City, KS 66160
KU Innovation and Collaboration
3901 Rainbow MS 2019
Kansas City, KS 66160
KUMC strives to assure that its research and other activities are not compromised or perceived as biased by financial and business considerations.
Institutional Conflict of Interest: An institutional conflict of interest ("Institutional COI") describes a situation in which the financial interests of an institution or a University Official, acting within his or her authority on behalf of the institution, may affect or appear to affect the research, education, clinical care, business transactions, or other activities of the institution. An Institutional conflict of interest may occur when the university, University Official, or affiliated organizations have a financial interest in a company that is associated with university research or other university activities. Examples of situations that can create potential institutional conflicts include investments in start-up companies associated with faculty inventions or stock ownership in or receipt of royalties from companies that conduct research at the university.
University Official: An individual who, because of his or her position with KUMC, has the capacity to affect, or can reasonably appear to affect, the research, education, clinical care, business transactions or other activities of KUMC. Such officials include but are not limited to the Chancellor, the Executive Vice Chancellor, Deans, Associate Deans, Vice Chancellors, Associate Vice Chancellors, Department Chairs and directors of research units.
05/06/2016: Removed Date Last Reviewed
11/20/2015: Major rev; signed by EVC