COI Committee: Evaluating Conflicts of Interest

Overview

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 and COI Committee membership presents an evaluation 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.

Review Criteria

Review criteria includes: (a) the research activities of an individual making an Outside Activities Report (OAR), (b) whether the activity is reportable on the OAR, (c) the value of the financial interest associated with an activity, and d) whether the activity is on-going or has ended. 

Research 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 human subjects research administered by UW-Madison. For the activity to be reviewed, one of the two following criteria must be true:

  • The individual's position at UW-Madison would allow him or her to affect the design, conduct, or reporting of federally funded research, or
  • The individual is a principal investigator (PI), co-investigator, or other senior/key personnel on human subjects protocols reviewed by UW-Madison IRBs and is (a) a UW-Madison employee, (b) a UW-Madison student, or (c) a UW-Madison agent (i.e., an individual who is not an employee but holds an appointment at UW-Madison). The UW-Madison COI Committee does not review or manage outside activities of non UW-Madison employees or students, or individuals who do not otherwise hold a UW-Madison appointment.

At the request of a Dean's Office or a UW-Madison IRB, the COI Committee may also review the outside activities of any investigator and provide advice on the existence of an FCOI.

Disclosable Activities

The COI Committee only reviews activities that are disclosable on the annual OAR. A detailed description of disclosable and non-disclosable activities is available on the Outside Activities Reporting page.

Value of Financial Interest

The COI Committee reviews activities that meet or exceed the following financial thresholds:

  • 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.

Time Period

University of Wisconsin System Board of Regents policy, UWS8, requires individuals to disclose all activities from the previous calendar year on the OAR and to update throughout the year as appropriate. Federal regulations require an update of the OAR within 30 days of acquiring a new SFI, 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.

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.

Determining Nexus

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.

Management Condition Summary

The COI Committee uses a standardized management plan. You may access an example here Financial Conflict of Interest Management Plan Example.

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.
  • COI Committee staff informs the investigator in a letter that a management plan has been terminated.
Review of Consulting Businesses
Consulting businesses established by the unclassified staff are reviewed by the COI Program 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.
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 greater than $5000 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 based on the existing review criteria.

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 Program under the federal regulations if that ownership, by itself or when combined with compensation received from that company, equals $5000 or greater.

The COI Program 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 Program finds that any of the above conditions are present along with an individual's equity ownership in the publicly traded company, then the COI Program may recommend 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 Program 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 (PHS Only)

Federal Regulations require PHS-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. PHS-funded investigators' initial disclosure must include all reimbursed and sponsored travel over the previous twelve-month period. They must also report any travel that is reimbursed or sponsored by an outside entity related to their institutional responsibilities within 30 days of the start of the travel event. Investigators may report anticipated reimbursed or sponsored travel prior to the start of the travel event. Please note that the federal regulations do not provide a de minimis threshold for the disclosure of the reimbursed or sponsored travel, but instead simply require disclosure of each travel event.

For investigators with PHS-funded research, the following types of travel do NOT need to be reported:
  • Self-funded travel;
  • Travel covered through UW-Madison e-Reimbursement system;
  • Travel funded through UW-Madison;
  • Travel reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education (defined as 20 USC 1001(a)), an academic teaching hospital, a medical center, or a research institution that is affiliated with an institution of higher education (the exception described here applies only to U.S.-based institutions and agencies); and
  • Travel reimbursed or sponsored by the National Research Commission or the related National Academies.
UW-Madison investigators with PHS-funded research will provide the following information when reporting a travel event:
  • Purpose of the trip;
  • The identity of the sponsor/organizer,
  • The destination, and
  • The duration.
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.



Keywords:   Doc ID:33096
Owner:Samuel L.Group:VCRGE and Graduate School
Created:2013-08-29 10:46 CDTUpdated:2017-02-20 16:38 CDT
Sites:VCRGE and Graduate School
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