Institutional Conflict of Interest (ICOI) Policy

Adopted By: Research Policy Advisory Committee
Adoption Date: December 18, 2008
Approved By: Chancellor
Approval Date: November 1, 2011
Reviewed By: University Committee January 17, 2012
Revised By: Institutional Conflict of Interest Committee August 24, 2012
Revised By: Chancellor
Revision Date: December 11, 2015

Preamble

As the University of Wisconsin–Madison (University) collaborates with an ever-expanding network of affiliated organizations to apply the fruits of research and scholarship to benefit society, the potential exists for institutional conflicts of interest. The following policy signals our commitment to the disclosure, identification, and management of institutional conflicts of interest.

Purpose

This policy is provided to help the University examine circumstances surrounding gifts, grants and personal holdings, and manage (through disclosure, separation of responsibilities or other appropriate requirements), any actual or apparent conflicts of interest that may result.

Scope

The University operates through the actions of University Officials, individuals with administrative authority and responsibility. This policy governs institutional conflicts of interest at the University and applies to University Officials.

The Wisconsin Alumni Research Foundation (WARF), the University of Wisconsin Medical Foundation (UWMF), the University of Wisconsin Hospital and Clinics (UWHC), the Morgridge Research Institute, WiCell, and the University of Wisconsin Foundation (UWF) are organizations that are separate and independent from the University. Because of the independent nature of these organizations, unless specifically addressed in this policy, the actions of these organizations are sufficiently outside the control of the University or a University Official that no Institutional COI evaluation is needed.

This policy does not govern situations in which individuals who are not University Officials might realize financial gain from the conduct of research or performance of other responsibilities at the University; the University’s Conflict of Interest Committee, using existing policies and procedures, adequately identifies such situations and independently manages their associated risks to scientific objectivity and proper treatment of human subjects.

Definitions

Institutional Conflict of Interest.

The institution may have a conflict of interest (“Institutional COI” and also ICOI) whenever the financial interests of the institution, or of a University Official acting within his or her authority on behalf of the institution, might affect – or reasonably appear to affect – institutional processes for the selection, design, conduct, reporting, review, or oversight of the University enterprise. For the purposes of evaluating ICOI, activities related to research, teaching and outreach, and the administration of those functions, singly and collectively represent the University enterprise.

University Official.

University Official shall mean persons with the power to commit substantial resources of the University. University Officials include, but are not limited to, Chancellors, Vice Chancellors, Provosts, Vice Provosts and Deans, including those holding these positions in an interim capacity. These individuals have a responsibility to identify others who have discretionary authority to allocate resources related to the University enterprise.

Significant Financial Interest.

For the purposes of evaluating ICOI, the definition of a Significant Financial Interest will be the same as stated in the Code of Federal Regulations at 42CFR50.603 (see Appendix I).

Guiding Principles

The following principles shall guide the University in addressing Institutional COI:

Institutional financial or business considerations must not be allowed to undermine the objectivity of research, teaching and outreach at the University.

The numerous and complex relationships between the University and public and private entities require the University to be aware of any relationships that may compromise or appear to compromise its integrity.

The University’s Conflict of Interest Committee, using existing policies and procedures, identifies situations in which individuals might realize financial gain from the conduct of research at the University and independently manages the risks to scientific objectivity and proper treatment of human subjects associated with such situations.

Institutional Policies and Procedures

The Board of Regents of the University of Wisconsin System, the UWF, and the University have established policies regarding the acceptance of extramural support, including gifts, grants, contracts, and cooperative agreements. These policies apply to University Officials as defined here and are summarized below.

Gifts/Grants from Sponsors.

All gifts and grants to the University must be accepted in conformance with the following policies:

Allocation of Resources or Direction/Control of University Activities.

The following circumstances should be evaluated when considering decisions to commit substantial resources of the University or when University Officials are responsible for the direction/control of significant University activities:

Reservation of Authority

The Chancellor, or his/her designee, has the authority to implement disclosure and review processes, to oversee procedures to address Institutional COI, and to develop and monitor plans for managing, reducing or eliminating Institutional COI, involving:

In these instances of conflict of interest, the Office of the Vice Chancellor for Research and Graduate Education’s Associate Vice Chancellor for Research Policy and Integrity shall consult with the Chancellor.

In instances where the Chancellor may have an Institutional COI, he or she must recuse himself or herself and defer to the President of the University of Wisconsin System, who will review, create and approve management plans in consultation with the Office of the Vice Chancellor for Research and Graduate Education’s Associate Vice Chancellor for Research Policy and Integrity shall consult with the Chancellor.

Disclosures

Disclosure to Institution.

University Officials and other individuals covered under this policy shall, upon appointment and annually thereafter, file a financial disclosure statement with the Office of the Chancellor disclosing Significant Financial Interests. For those required to file it, a Wisconsin Statement of Economic Interests is sufficient to fulfill this disclosure requirement. Those not required to file a Wisconsin Statement of Economic Interests will receive a university form designed for this process.

Disclosure to Institutional Review Boards.

University Officials and other individuals covered under this policy shall disclose to campus Institutional Review Boards (IRBs) any conflicts of interest they may have, as well as any management plans or exceptions to management issued by the COI Committee, with regard to their human subjects research activities reviewed by the campus IRBs. Such disclosures occur by answering the standard conflict of interest questions in IRB applications. (See "Financial Conflicts of Interest in Human Subjects Research: Policies and Procedures, Appendix 2. Procedures, (a) Reporting, (ii) To IRBs", found at https://research.wisc.edu/respolcomp/hrpp/).

Notification of Changes in Significant Financial Interests.

University Officials and other individuals covered under this policy shall provide a revised financial disclosure statement through appropriate Outside Activities Reporting processes within 30 days of acquiring any new Significant Financial Interests.

Related document:Institutional Conflict of Interest (ICOI) Procedures

Appendix I: Definition of Significant Financial Interest

Significant financial interest means an interest consisting of one or more of the following interests of a University Official (and those of the University Official’s spouse and dependent children) that reasonably appears to be related to the University Official’s institutional responsibilities:

  1. Interests in publicly traded entities.
    1. Remuneration (salary, consulting fees, honoraria, paid authorship, etc.) received from the entity in the twelve months preceding disclosure, and the value of any equity interest (stock, stock option, or other ownership interest) in the entity at the date of disclosure that, when aggregated, exceed $5,000.
  2. Interests in non-publicly traded entities.
    1. Remuneration (salary, consulting fees, honoraria, paid authorship, etc.) received from the entity in the twelve months preceding disclosure that, when aggregated, exceeds $5,000 in the twelve months preceding the disclosure; or
    2. Any equity interest (e.g. stock, stock option, or other ownership interest).
  3. Intellectual property rights and interests (e.g., patents, copyrights) upon receipt of income related to such rights and interests.
  4. Service in positions with fiduciary responsibility, including senior managers (e.g. presidents, vice presidents, etc.) and members of boards of directors, whether or not the University Official receives compensation for such service.

Exceptions.

Significant financial interests do not include the following:

  1. Salary, royalties, or other remuneration received from UW–Madison or the University of Wisconsin Medical Foundation;
  2. Royalty income from intellectual property rights arising out of UW–Madison employment that are assigned to organizations created to manage such rights on behalf of the University of Wisconsin–Madison;
  3. Income from investment vehicles, such as mutual funds and retirement accounts, as long as the University Official does not control the investment decisions made in these vehicles;
  4. Income from seminars, lectures, or teaching engagements sponsored by a domestic government agency, a university, an academic teaching hospital, a medical center, or a research institute that is affiliated with a university;
  5. Income from service on advisory committees or review panels for a domestic government agency, a university, an academic teaching hospital, a medical center, or a research institute that is affiliated with a university.

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