COI Committee: Evaluating Conflicts of Interest
The UW–Madison COI Office is responsible for initial review of all financial disclosures by all investigators and determines whether any meet the definition of significant financial interest (SFI). If so, the COI Office and COI Committee membership will evaluate whether the SFI could directly and significantly affect the design, conduct, or reporting of federally funded or human subjects research, or whether the financial interests of the outside entity could be directly and significantly affected by the research. The COI Office presents an evaluation of outside activities for COI Committee discussion and action. The COI Committee indicates that a financial conflict of interest (FCOI) exists by majority vote of the eligible members.
Under federal regulations, UW–Madison is required to develop management plans for SFIs that are determined to be a financial conflict of interest, including those of sub-recipient investigators.
UW–Madison is also required to monitor compliance with the management plan. If UW–Madison identifies an SFI that was not disclosed or reviewed in a timely manner, the COI Office will, within sixty (60) days, review the SFI, determine if an FCOI exists and implement an interim management plan, if needed. In cases of non-compliance, the COI Office will also complete a retrospective review and submit a Mitigation Report if bias is found.
COI Committee Makeup
The COI Committee is made up of 12-18 voting members and at least one Chair. Both faculty and academic staff may be members. Members represent a wide range of disciplines and colleges on campus.
The COI Committee meets once a month from September through June, generally the 3rd Friday of the month at 8:30am. During July and August, the COI Committee meets as needed for time sensitive reviews (e.g., exception requests). Meetings are held in Bascom Hall and the Health Sciences Learning Center, alternating every other month.
As a governance committee, meetings are open to the public but also involve a closed session for the discussion of Outside Activities Reports (OARs), retrospective reviews, exception requests, and other sensitive information as state law allows.
Review of Outside Activities
The COI Committee reviews outside activities of individuals who are listed as principal investigator, co-investigator, or senior/key personnel on federally funded research or a study team member on human subjects research administered by UW–Madison. The COI Committee evaluates outside activities disclosed in the most current version of the OAR available when the meeting agenda is prepared. Activities are reviewed at least once annually and when substantive changes are made.
The COI Committee may also review the outside activities of any investigator and provide advice on the existence of an FCOI at the request of a Dean or Director's Office.
UW Madison request the reporting of more activities on the outside activities report that those that require review by the COI Committee.
The COI Committee reviews all reported activities that meet the federal definition of Significant Financial Interest (SFI) as well as any reported activities of an individual at the request of a Dean's office. The COI Office reviews all activities of an individual subject to the COI Policy, regardless if they meet the federal definition of SFI.
Value of Financial Interest
The COI Committee reviews activities that meet or exceed the following financial thresholds as they are considered Significant Financial Interests under the federal regulations:
- Compensation and/or ownership in a publicly traded company that, either individually or combined, equals $5,000 or more in a calendar year;
- Compensation of $5,000 or more from a privately held company in a calendar year;
- Any ownership interest in a privately held company; or
- Any leadership position, where leadership positions are defined as positions with fiduciary responsibility including senior managers (presidents, vice presidents, etc.), and members of boards of directors. Membership on a scientific advisory board is not a leadership position.
University of Wisconsin System Board of Regents policy, UWS8, requires individuals to disclose all activities related to his or her institutional responsibilities from the previous calendar year on the OAR by April 30th. Institutional responsibilities include all professional activities taken on behalf of the University, including: research, teaching, outreach, professional practice, administration, and University committee memberships. Federal regulations require an update of the OAR within 30 days of beginning a new outside activity and include travel events for PHS funded researchers. The COI Committee evaluates outside activities disclosed in the most current version of the OAR available at the time of preparation of the review meeting agenda.
While assessing the need for management, the COI committee considers whether an outside activity or significant financial interest has a "nexus" with the individual's research activities at UW–Madison.
An outside activity has a nexus with an individual's research activities if the outside activity arises from or relies upon the academic expertise that qualifies that individual to participate in federally funded research or human subjects research and the outside activity or interest could directly and significantly affect the individual's research. The potential for conflict with an outside activity or financial interest is strengthened by other relationships between the individual or his or her immediate family and the business entity associated with the financial interest or outside activity.
No Management Financial Interests
While some outside activities meet the criteria for review, the COI Office or COI Committee may determine that these do not require management and assign them to "no management" status. Such activities include:
- Salary, royalties, or other remuneration received from UW–Madison or affiliated entities (e.g., UW Hospital and Clinics, the VA Hospital, the UW Medical Foundation);
- Royalties generated by intellectual property rights arising out of university employment that are assigned to organizations created to manage such rights on behalf of UW–Madison, for example, Wisconsin Alumni Research Foundation and Wisconsin Center for Educational Products and Services;
- Income from seminars, lectures, or teaching engagements sponsored by a government agency, a university, an academic teaching hospital, a medical center, or a research institute that is affiliated with a university;
- Income from service on advisory committees or review panels for a government agency, a university, an academic teaching hospital, a medical center, or a research institute that is affiliated with a university;
- Travel related to institutional responsibilities that is reimbursed or sponsored by a U.S. government agency, a U.S. university, academic teaching hospital, or medical center, or a research institute that is affiliated with a U.S. university; and
- Interests of any amount in investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not control the investment decisions made in these vehicles.
Management Condition Summary
The COI Committee uses a standardized management plan. You may access an example here 33310.
Terminating a Management Plan
When an investigator ends his or her relationship with an outside entity for which a management plan was issued, the investigator should update his or her OAR to reflect the change in the relationship. The termination process is as follows:
- An investigator files an updated OAR indicating that the relationship has ended.
- The COI Office presents a summary of the information provided in the request for termination of a management plan for consideration by the full COI Committee at its monthly meeting.
- If the COI Committee determines the plan is no longer necessary, the committee will vote to terminate the management plan.
- The investigator's outside activities dashboard will update to show "no management" for any ended management plan.
Review of Consulting Businesses
Consulting businesses established by an employee are reviewed by the COI Committee because this establishes ownership in a privately held entity. If the privately held entity appears to be a consulting only business, the reviewer should determine if the following conditions apply:
- Solely owned by the individual;
- No other employees; and
- The assets or value of the entity come from only consulting work and not products.
If all three conditions are true, the COI Program should recommend "no management" for the entity. Upon the COI Committee's approval, the COI Program will send a letter to the investigator with instructions stating that if the entity enters into a consulting agreement with an individual client with compensation of $5,000 or more in a single calendar year that has not already been reported, then the individual must update his or her OAR to report this client as a separate entity. The COI Committee will review entities disclosed in response to this letter.
If the COI Program determines one or more of the three conditions described above are not true, and that a nexus exists between the consulting business and the individual's institutional responsibilities, then the COI Program should recommend management for the entity.
Review of Equity Ownership in Publicly Traded Companies
An individual's equity ownership in a publicly traded company requires review by the COI Committee under the federal regulations if that ownership, by itself or when combined with compensation received from that company, equals $5000 or greater.
The COI Committee will consider additional factors when reviewing an individual's equity ownership in a publicly traded company:
- Whether the individual is a paid consultant for the entity;
- Whether the individual is engaged in research that is sponsored by the entity;
- Whether the individual oversees students who are supported by the entity;
- Whether the entity sponsors travel on behalf of the investigator; and
- Whether the individual is currently participating in or anticipates (in the coming year) participation in a clinical trial sponsored by the entity.
If the COI Committee finds that any of the above conditions are present along with an individual's equity ownership in the publicly traded company, then the COI Committee may require management of that individual's relationship with the entity. If none of these conditions are present and the individual only holds ownership in the publicly traded company, then the COI Committee will not recommend management of the relationship. The COI Program will send a letter to the investigator informing them that, should the investigator's relationship with the company change in any of the above conditions, the investigator should inform the COI Program within 30 days, which will require reevaluation of the investigator's financial interest with that company.
Review of Reimbursed or Sponsored Travel (Federally Funded Only)
Federal Regulations require federally funded investigators to report the occurrence of any reimbursed (i.e., paid to the investigator) or sponsored travel (i.e., sponsored travel is that which is paid on behalf of the investigator so that the exact monetary value may not be known) related to the investigator's institutional responsibilities.
UW–Madison is responsible for determining whether travel constitutes a financial conflict of interest with PHS-funded research. Travel to scientific meetings and to present investigator's research to colleagues and other interested parties are integral parts of the scientific research enterprise and afford important opportunities for forging relationships and collaborations among researchers. UW–Madison COI policy is not intended to discourage this type of travel.