Conflicts of Interest of Non-UW-Madison Key Personnel

The UW-Madison has legal and ethical responsibilities to review and, where appropriate, to reduce, eliminate, or manage potential financial conflicts of interest in research involving human participants under its purview. This policy describes how the UW-Madison handles conflicts of interest of non-UW-Madison key personnel listed on human participants studies under the purview of a UW-Madison IRB.

  1. To ensure that the safety of research participants is adequately protected, the UW-Madison:

    1. requires reporting and review of significant financial interests (SFIs) that might present a real or potential conflict of interest with the individual's research prior to final IRB approval of the research;

    2. and limits the participation of individuals who hold SFIs (e.g., if the entity or entities that they have an SFI with sponsors the study or owns or licenses a technology used in the study) related to a research project involving human participants in that study.

  2. If a researcher listed on a human participants research study reviewed by one of the UW-Madison IRBs discloses a SFI in the IRB application, but does not provide a management plan, one of the following actions will be taken.

    1. Individual investigators (not affiliated with any institution) or investigators affiliated with an institution that does not have a COI management process are subject to UW-Madison’s COI policies and processes.

    2. Individuals affiliated with an institution that has a COI process are subject to their institution’s COI policies and must submit their management plan to the UW-Madison IRB.

      1. Regardless of the management plan put in place by the individual's home institution, the IRB may determine that additional measures are needed to protect the rights and welfare of research participants, including not permitting the individual to be engaged in the research as an investigator or key personnel.

    3. The IRB has the authority to grant an exception to the research participants prohibition for a study with no more than minimal risk. (If the research is greater than minimal risk, only the COI Committee can grant an exception.)

      1. When making an exception to the research participants prohibition, the IRB will consider whether the existing plan sufficiently protects the rights and welfare of human participants.

        1. For example, the IRB may consider whether the plan includes any of the following:

          1. Disclosure of the individual's significant financial relationship to participants.

          2. A prohibition on the individual serving in certain capacities in the research (e.g. a prohibition on recruiting participants or obtaining informed consent).

          3. A requirement for an independent data safety monitoring committee.

          4. A prohibition on receipt of payments from the entity for particular research results or for research outcomes related to human participant studies.

          5. Disclosure of the individual's significant financial relationship in publications and academic presentations.

          6. Notification of the individual's significant financial relationship to other investigators engaged in the research.

Adopted By: Human Research Protection Program Advisory Committee
Adoption Date: November 4, 2010
Revised: December 5, 2012
Revised By: Cross-Campus Human Research Protection Program (HRPP) Committee
Revision Date: October 13, 2015

Copyright © 2015 University of Wisconsin System Board of Regents

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Keywords:COI non-UW-Madison researcher UW-Madison human research study study   Doc ID:29796
Owner:Ryan M.Group:VCRGE and Graduate School
Created:2013-04-22 16:11 CDTUpdated:2015-10-19 12:20 CDT
Sites:VCRGE and Graduate School
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