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UW–Madison Office of Research Policy and Integrity Financial Conflict of Interest Policy and Procedures: Guidance Document
Last revised 8/24/2023
This document provides guidance on the COI Policy and Procedures at the University of Wisconsin–Madison.
Table of Contents
Purpose
The purpose of this document is to clarify sections of UW–Madison's Conflict of Interest (COI) policy document.
Introduction
The UW–Madison Office of the Vice Chancellor for Research and Graduate Education has the responsibility and authority to determine the existence of a financial conflict of interest (FCOI). The Vice Chancellor for Research and Graduate Education delegates this responsibility and authority to the Associate Vice Chancellor for Research Policy and Integrity who manages the UW–Madison Conflict of Interest Program. The Chancellor appoints the voting members to the Conflict of Interest Committee (COI Committee) based upon the recommendation of the Vice Chancellor for Research and Graduate Education.
The COI Committee is made up of 12-18 voting members and at least one Chair. It meets once a month from September through June and as needed in July and August. Both faculty and academic staff may be voting members, although faculty serving as Deans or Associate Deans may not be regular voting members of the committee. Members represent a wide range of disciplines and colleges on campus. The COI Committee seeks to maintain a balance of clinical and non-clinical researchers, of individuals engaging in entrepreneurial activities, of representatives from larger and smaller colleges and schools, and of men and women. The committee also works with faculty and staff to eliminate, minimize, and manage any actual or potential conflicts of interest identified by the disclosure process.
Both federal regulations, 42 CFR Part 50, Subpart F, and 45 CFR Part 94, University of Wisconsin System Board of Regents policy, and University of Wisconsin System Chapter 8 (UWS8) require disclosure of outside financial interests and inform UW–Madison's COI policy and the operations of the COI program. The federal regulations state that a financial conflict of interest exists when an investigator has a significant financial interest (SFI) that could lead an independent observer to reasonably question whether the design, conduct, or reporting of research might be influenced by the possibility of personal gain to the individual, or his or her spouse and/or dependent children. Financial conflicts of interest therefore require careful oversight from the University.
UW–Madison recognizes that FCOIs:
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Represent a state of affairs, not behavior;
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Frequently involve perceptions; and
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Are judged by others, not by those directly involved.
This document describes the actions UW–Madison and its investigators are required to take in order to comply with federal, University of Wisconsin System, and UW–Madison COI policies. The UW–Madison COI Program in the Office of Research Policy and Integrity is responsible for carrying out the COI policies and regulations.
Outside Activities Reporting
Who Needs to File an Outside Activities Report (OAR)
Who Should Make a Report
- All UW–Madison faculty, regardless of appointment level
- All UW–Madison academic staff and limited appointees with total appointments equaling 50% or greater
- All PIs, co-investigators, and senior/key personnel on current federal grants
- All individuals listed as study team members on human subjects protocols approved by UW-Madison's Institutional Review Boards (IRBs) or human subjects protocols where IRB review was ceded to an external IRB, unless conflict of interest issues have been assigned to an outside institution through the reliance process.
- All individuals with an active management plan from the COI Committee
- All individuals with outside activities that need to be reported on an OAR because of a supervisor's management plan
- Fellows, grad students, and post-docs who participate in research or service arrangements with non-federal entities
Individuals must submit an OAR even if they have no outside financial interests related to their institutional responsibilities at the University.
When to File OARs and Make Updates
- Annual report: You must submit an annual report by April 30th. You will be notified to fill out your annual report in early January each year you are required to file an OAR.
- After changes to your outside activities occur: You must also file an updated OAR anytime there is a relevant change in your outside activities. This must be done within 30 days of acquiring a new outside activity or within 30 days of experiencing a change in an existing outside activity.
- Examples of relevant changes include, among other things:
- A new relationship with an outside organization;
- New roles or positions within organizations, such as board of directors membership or executive positions;
- New or changed forms of ownership, such as intellectual property rights, stock, stock options, or equity interest; and
- Increases or decreases in the amount or kind of compensation or remuneration received from an entity.
- Examples of changes that are not relevant:
- If you have a salaried position and have reported your expected annual compensation, it is not necessary to update your OAR every time you receive a paycheck
- If you have already reported more than $5,000 of monetary compensation for the year, it is not necessary to update your OAR when you receive more compensation until next year's annual report.
- Examples of relevant changes include, among other things:
- Public Health Service (PHS) or Department of Energy (DOE) Award set up: Your OAR must be up-to-date before a PHS or DOE award setup can be completed.
- Travel for Federally Funded Researchers: You must report any travel that is reimbursed or sponsored by an outside entity related to your institutional responsibilities within 30 days of the start of the travel event.
Note: The Public Health Service (PHS) of the U.S. Department of Health and Human Services includes any agency or unit of the PHS to which it may delegate its authority, including the National Institutes of Health. Many of these agencies are further subdivided into different awarding components. Some non-PHS organizations have also adopted the PHS regulations. For further information on these organizations, contact the UW–Madison Office of Research and Sponsored Programs.
What to Report: Reportable and Non-reportable Outside Financial Activities
Overview
Individuals who are subject to the UW–Madison COI Policy and who are required to file an OAR must report all outside financial interests that are related to their institutional responsibilities including those of their spouse and dependent children. The federal regulations consider "institutional responsibilities" to include all professional responsibilities done on behalf of UW–Madison, including: research, research consultation, teaching, professional practice, outreach, administration, and institutional committee memberships.
Types of Outside Activities
Individuals must report any activity or relationship where any compensation is received by the individual, their spouse, or dependent children. This includes, but is not limited to: salaries not from UW-Madison, consulting fees, gifts, honoraria, payments for sitting on advisory boards, royalties, and travel reimbursements that exceed actual travel costs.
Individuals must also report any ownership interest in a company including: stock, stock options, sole proprietorships, and limited liability companies, regardless of the value of the company.
Additionally, UW-Madison's Conflict of Commitment policy requires all academic appointments with foreign entities to be reported whether they are paid or unpaid.
Lastly, regardless of compensation, service in positions with fiduciary responsibilities must be reported. This includes executive positions, senior management positions, or membership on boards of directors.
Outside Activity Reporting for Consulting Entities
An individual should report ownership in any privately held entity, including consulting businesses, and the total compensation received from the entity. An individual should also disclose each client of the consulting business, as a separate disclosure, with the total compensation received from that client, if the compensation is $5,000 or more in a reporting year, if the consulting entity received any equity from a client, or if there are interactions between UW-Madison and the client that involve the individual consultant (e.g., a contract that names the individual consultant).
An individual's dean's office may require the disclosure of known clients of the consulting entity at any time.
Mandatory Travel Reporting for Federally Funded Investigators
Federally funded investigators' initial disclosures 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. This reporting requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local U.S. government agency, a U.S. institution of higher education, a U.S. academic teaching hospital, a U.S. medical center, a research institute that is affiliated with a U.S. institution of higher education, or travel covered through UW–Madison's e-Reimbursement system. In this context, "reimbursed" means payments made by an outside entity to cover expenses paid by a federally funded investigator as part of the travel event; "sponsored" means expenditures made by the entity without transfer of funds to the federally funded investigator. The information to be reported includes:
- Purpose of the trip;
- Identity of the sponsor/organizer;
- Destination; and
- Duration of travel.
Table 1:
| Reportable Outside Financial Activities | Non-Reportable Outside Financial Activities |
|---|---|
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| Reportable Outside Financial Activities | Non-Reportable Outside Financial Activities |
|---|---|
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| Reportable Outside Financial Activities | Non-Reportable Outside Financial Activities |
|---|---|
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Service in positions with fiduciary responsibility, including executive positions, senior management positions, trusteeships, or membership on boards of directors. |
Leadership positions that do not relate to your institutional responsibilities, or that do not have fiduciary responsibilities. |
| Reportable Outside Financial Activities | Non-Reportable Outside Financial Activities |
|---|---|
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Investigators with federally funded research must disclose travel events, such as:
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For investigators with federally funded research, the following types of travel do not need to be disclosed:
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1.3 Proxies
In limited circumstances, designated proxies can assist users who need help preparing their OARs by entering and updating required information but will not be able to submit or certify OARs on their behalf. An Associate Vice Chancellor in the Office of the Vice Chancellor for Research and Graduate Education must approve access, which is typically reserved for individuals who have a demonstrated history of filing multiple OARs each year, or persons who are experiencing accessibility issues with the OAR website. Requests for proxy access can be submitted to coiprogram@research.wisc.edu.
TopCOI Training
Overview
UW–Madison requires all investigators engaged in federally funded or human subjects research to receive training in financial conflicts of interest. This training must be completed every four years and on other occasions, when investigators are specifically notified by University officials. The course is offered through Canvas. Individuals will be notified to retake your COI training before the training expires.
UW–Madison Office of Research and Sponsored Programs (RSP) checks COI training status each time they begin the setup of an award account for every PI and senior/key personnel. COI training must be up-to-date upon submitting new federal grant applications and at the beginning of award setup. Spending on new and non-competing federally funded award accounts will not be permitted until your COI training is complete.
For detailed information on how to complete COI training, please see our Conflict of Interest Training Course page.
University's Review of Disclosures
Overview
The COI Office reviews OARs and determines whether any of the activities meet federal criteria for significant financial interest (42 CFR 50.603; NSF Grant Policy Manual 510).
Significant Financial Interest (SFI)
According to federal regulations and UW–Madison policy, the following interests of an investigator, or an investigator's spouse or dependent children, constitute an SFI.
- For publicly traded entities:
- The value of remuneration received from an entity in the twelve months preceding disclosure, in combination with the value of any equity interest in the company as of the date of disclosure, equals $5,000 or more;
- For non-publicly traded entities:
- The value of any remuneration received from the entity in the twelve months preceding disclosure equals $5,000 or more;
- Any equity interest in the company;
- Any income from intellectual property rights that are not assigned to organizations created to manage such rights on behalf of UW–Madison;
- Service in positions with fiduciary responsibility. This includes executive positions, senior management positions, or membership on boards of directors; and
- For those that receive federal funding, reimbursed or sponsored travel.
Review of SFIs
If an activity meets the definition of SFI, the COI Office makes a recommendation of management or no management. It then assigns at least one COI Committee member to review the reported activity and recommendation from the COI Office for further discussion at the next COI Committee Meeting. During the review, the COI Committee member (1) determines whether there is a nexus between an investigator's research and the significant financial interest; (2) determines whether a financial conflict of interest (FCOI) exists; and (3) notes whether they agree with the COI Office's management recommendation. The full committee then votes by simple majority to confirm the recommendation or suggest a change. If it is determined by the committee that an FCOI exists, a management plan is assigned to the investigator that specifies actions that have been, or will be, taken to manage the FCOI.
A significant financial interest is a financial conflict of interest if the interest could directly and significantly affect the design, conduct, or reporting of research.
Management Plan
If the COI Committee determines an investigator's financial interests constitute an FCOI, a management plan will be developed for the investigator in order to minimize or eliminate the conflict. An investigator will receive an email notice from the COI Program with further instructions if a management plan is assigned.
An example of a management plan can be viewed here: Financial Conflict of Interest Management Plan
If a management plan is created for you
- You are responsible for all of its terms and conditions and need to cooperate with the University's efforts to monitor your compliance with the management plan. Additionally, if you are on a protocol that is subject to IRB review, you must inform the IRB of any changes or updates to your management plan(s).
- Noncompliance with a management plan shall result in a retrospective review of your outside activities and PHS-funded and DOE-funded projects.
- PHS funding that is related to your management plan will not be available for spending until you have electronically accepted your management plan.
- Management plans prohibit participation in human subjects research when a managed entity sponsors the study, or own or license a technology used in the study.
Requesting an Exception to the Restriction on Participation in Human Subjects Research
- You may apply for an exception to the restrictions on participation in human subjects research in collaboration with your dean's office.
- For all protocols that are greater than minimal risk, you must work with your dean's office to request an exception to your management plan. If the dean's office agrees to support your exception request, they will prepare a memorandum outlining the basis for the exception, and their willingness to participate in additional management actions.
- Additional management actions include: disclosure of financial interests to participants and research collaborators, additional protocol monitoring, restriction of your roles in the study, independent data analysis and other management, as determined by the committee.
- The dean's representative will share this memorandum with the COI Committee at the next COI Committee meeting. After the meeting, you will be notified of whether your exception has been granted.
- The IRB has authority to require disclosure of the FCOI in the consent form as well as restrict your participation in the recruitment of study participants for any study if the IRB determines either is necessary to protect research participants.
Appealing a Management Plan
If you disagree with the assignment of a management plan, you may make a written request of reconsideration by contacting your school or college's Dean's Office and the COI program at coiprogram@research.wisc.edu. Please note that the appeal process may delay spending on PHS or DOE awards.
Terminating a Management Plan
If the circumstances of a managed outside activity change so that they meet one of the criteria listed below, please contact the COI Program at coiprogram@research.wisc.edu, or call 608-890-4460 or 608-890-4603 to request termination of your management plan. Termination of an existing management plan requires explicit action from the UW–Madison COI Committee.
You should consider contacting the COI office if:
- You are no longer employed by UW–Madison;
- The managed entity has dissolved;
- Your relationship with the managed entity has ended;
- Your compensation from the managed entity has fallen below the PHS management threshold; or
- You no longer participate in either human subjects research or federally funded research.
Compliance
Monitoring Compliance
UW–Madison is required to monitor investigator compliance with management plans and provide reports on FCOIs and instances of bias to PHS. If the COI program finds noncompliance because an investigator has failed to disclose a reportable outside financial interest or failed to comply with a management plan, the COI Committee may impose the following sanctions:
- Require the investigator to complete additional training;
- Withhold research funding and/or other appropriate disciplinary actions;
- Conduct a retrospective review; and/or
- Report the noncompliance to the PHS awarding component.
Retrospective Review
If a PHS-funded or Department of Energy (DOE)-funded investigator does not report a Significant Financial Interest in a timely manner, UW–Madison needs to review the SFI to determine if there is an FCOI, and if an FCOI is found, complete a retrospective review. UW-Madison must complete the retrospective review within 120 days of the determination of noncompliance. The retrospective review must determine whether any PHS or DOE-funded research conducted during the period of noncompliance was biased in its design, conduct, or reporting.
If the retrospective review committee makes a determination of bias, UW–Madison will notify the appropriate federal agency of its findings, along with a mitigation report that includes: (1) the key elements documented in the retrospective review; (2) a description of the impact of the bias on the research project; and (3) UW–Madison's plan of action for eliminating and mitigating the effects of the bias.
Reporting to Awarding Agencies
Under federal regulations, UW-Madison must provide FCOI Reports to the PHS awarding component for all investigators on PHS-funded research projects prior to the expenditure of any funds. The UW-Madison COI Office provides the required information to the Research and Sponsored Programs (RSP) Office for reporting to the appropriate awarding component. This information includes:
- The name of the investigators with the FCOI;
- The name of the entity with which the investigator has an FCOI;
- The nature of the FCOI;
- The value of the financial interest in a dollar range;
- A description of how the financial interest relates to the PHS-funded research and the basis for UW-Madison's determination that the financial interest conflicts with such research; and
- Key elements of the investigator's management plan.