Financial Conflict of Interest Policy and Procedures: Guidance Document

This document provides guidance on the COI Policy and Procedures at the University of Wisconsin Madison.

 

UW-Madison Office of Research Policy

Financial Conflict of Interest Policy and Procedures:

Guidance Document

Created 7/2012

Last revised 8/17/2015



        1.3 What to Report: Reportable and Non-Reportable Outside Financial Activities

Table 1

2.0 COI Training

3.0 University's Review of Disclosures

4.0 Management Plans 

   4.1 Requesting an Exception to the Restriction on Participation in Human Subjects Research      

   4.2 Appealing a Management Plan

   4.3 Terminating a Management Plan 

5.0 Compliance 

5.1 Monitoring Compliance

5.2 Retrospective Review 

  Purpose

The purpose of this document is to clarify sections of UW-Madison's Conflict of Interest (COI) policy document and identify what investigators must do to comply with UW-Madison's COI policy.

  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 who manages the UW-Madison Conflict of Interest Program. The Chancellor appoints the voting membership and ex officio participants 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 a Chair. Both faculty and academic staff may be 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 faculty 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:

1. Represent a state of affairs, not behavior;

2. Frequently involve perceptions; and

3. Are judged by others, not by those directly involved.

This document describes the actions investigators and UW-Madison 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 is responsible for carrying out the COI policies and regulations.  

 1.0 Outside Activities Reporting

 1.1. 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 PIs, co-investigators, and senior/key personnel on research protocols involving human subjects
  • All individuals with an active management plan from the COI Committee
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; and
      • 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 the annual report.
  • PHS award proposals: You must update your OAR prior to submitting proposals for PHS funding.
  • PHS Award set up: You must update your OAR within 30 days of a PHS award account setup beginning.
  • PHS travel: 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. 

 1.2 How to File an OAR
  1. Go to your Outside Activities Report.
  2. Select "Submit or Update an Outside Activities Report" and login with your NetID.
  3. Click on the "Start" button of the first page.
  4. Enter your personal information and select your appropriate campus appointment.
  5. Indicate whether you have any affiliation with the University of Wisconsin Medical Foundation.
  6. Answer and confirm three basic questions about your research activities at UW-Madison.
  7. If you have outside activities that relate to your institutional responsibilities, you must disclose them. To do so, create "entities" and answer the questions with which you are prompted. Make sure to save your responses.
  8. Certify that you have, to the best of your ability, answered all questions about your outside financial interests and have provided accurate information about them.
  9. Submit the report.
If you have questions about the form, how to use it, or anything else related to outside activity reporting, please see: Who to Contact for Assistance.

     1.3 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. 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 should report all outside financial interests that are related to their institutional responsibilities, including those of their spouses and dependent children. Outside financial interests include any activity or relationship that has monetary value, unless the interest is exempt from reporting (see Table 1: Financial interests that are NOT reportable). 

    Additionally, 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 separately with the total compensation received from that client if the compensation is greater than $5,000 in a reporting year. 

    Mandatory Travel Reporting for PHS-Funded Investigators

    PHS-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 government agency, a U.S. institution of higher education, an academic teaching hospital, a 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 PHS-funded investigator as part of the travel event; "sponsored" means expenditures made by the entity without transfer of funds to the PHS-funded investigator. The information to be reported includes:

    • Purpose of the trip;
    • Identity of the sponsor/organizer; 
    • Destination; and
    • Duration of travel.
     Table 1:

    Compensation

    Reportable Outside Financial Activities

    Non-Reportable Outside Financial Activities

    • Salary, unless it falls into one of the non-reportable categories

    • Spousal salary, if your spouse is employed in a field related to your institutional responsibilities

    • Consulting fees

    • Gifts or other awards, including gifts-in-kind, honoraria, and participation in promotional activities

    • Teaching services to another entity, unless it falls into one of the non-reportable categories

    • Income from editorial work (e.g., journal editorships or editing compilations of scholarly papers)

    • Payments that are connected to research, but are not governed by a research agreement between the sponsor and UW-Madison or the UW Medical Foundation.

    • Payments for serving on advisory boards

    • Royalty and copyright income not managed by the Wisconsin Alumni Research Foundation (WARF)

    • Income from activities sponsored by a foreign institution of higher education or a foreign governmental body

    • Travel reimbursements from businesses that exceed your actual travel costs

    • Compensation from activities NOT related to your institutional responsibilities at UW-Madison

    • Salary or other compensation from UW-Madison and affiliated entities, such as UW Hospital and Clinics, the UW Medical Foundation, the Center for Advanced Studies in Business, and the VA Hospital

    • Income from invited seminars, lectures, and teaching engagements at U.S. institutions of higher education, academic teaching hospitals, medical centers, or research institutions that are affiliated with an institution of higher education as defined by 20. U.S.C. § 1001(a)

    • Income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education as defined by 20 U.S.C. § 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education

    • Royalty income from intellectual property that arose from University employment and that was assigned to organizations that were created to manage intellectual property on behalf of UW-Madison (e.g., WARF, WCEPS)

    • Payments from grant or gift agreements between the sponsor and UW-Madison, or the UW Medical Foundation

    Ownership

    Reportable Outside Financial Activities

    Non-Reportable Outside Financial Activities

    • Stock

    • Stock options

    • Sole proprietorships

    • Partnerships

    • Limited liability corporations

    • Income from investment vehicles, such as mutual funds and retirement funds, is NOT reportable as long as you, your spouse, or dependent children do not directly control the vehicles' or funds' investment decisions
    • Interests in businesses or organizations that are unrelated to your institutional responsibilities

    Leadership

    Reportable Outside Financial Activities

    Non-Reportable Outside Financial Activities

    Service in positions with fiduciary responsibility, including executive positions, senior management positions, or membership on boards of directors.

    Leadership positions that do not relate to your institutional responsibilities, or that do not have fiduciary responsibilities.

    Travel (PHS Only)

    Reportable Outside Financial Activities

    Non-Reportable Outside Financial Activities

    Investigators with PHS-funded research must disclose travel events, such as:

    • Corporate-sponsored travel

    • Compensated vacation travel

    • Participation in a conference for a professional society

    • Travel sponsored by foreign institutes of higher education or foreign governmental agencies

    For investigators with PHS-funded research, the following types of travel do not need to be disclosed:

    • Self-funded travel

    • Travel covered through University of Wisconsin-Madison e-Reimbursement system

    • Travel funded through the University of Wisconsin-Madison

    • Travel reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education (defined at 20 USC 1001(a)), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education (the exception described here applies only to U.S.-based institutions and agencies)

    • Travel reimbursed or sponsored by the National Research Commission or the related National Academies


     2.0 COI 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 Learn@UW. You will be notified to retake your COI training before your training expires.

    The UW-Madison Office of Research and Sponsored Programs (RSP) will check your COI training status each time they begin the setup of an award account on which you are PI or senior/key personnel. You will be notified by email to make sure your COI training is 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. 
     3.0 University's Review of Disclosures

    Overview

    The COI Committee 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, exceeds $5,000;
    • For non-publicly traded entities:
      • The value of any remuneration received from the entity in the twelve months preceding disclosure exceeds $5,000;
      • 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 PHS funding, reimbursed or sponsored travel.
    Review of SFIs

    The UW-Madison COI Committee: (1) reviews disclosures from investigators' Outside Activities Reports (OARs) and determines if significant financial interests exist; (2) determines whether there is a nexus between an investigator's research and the significant financial interest; and (3) determines whether a financial conflict of interest exists. If there is an FCOI, the COI Committee develops and implements a management plan that specifies actions that have been, or will be, taken to manage the financial conflict of interest.

    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.

     4.0 Management Plans

    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 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).
    • 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.
     4.1 Requesting an Exception to the Restriction on Participation in Human Subjects Research
    • You may apply for an exception to the restriction on participation in human subjects research. Exception requests are only granted for specific protocols; therefore, every protocol requires a separate, explicit exception.
    • Protocols that have been determined to be of no greater than minimal risk do not require an exception and may proceed without one.
    • For all protocols that are greater than minimal risk, you must work with your Dean's office to request an exception. 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, disclosure of financial interests to research collaborators, additional protocol monitoring, restriction of your roles in the study, 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.
     4.2 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 awards. 

     4.3 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 human subjects research and federally funded research.

     5.0 Compliance

     5.1 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.
     5.2 Retrospective Review

    If a PHS-funded investigator does not report an 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. The retrospective review must determine whether any PHS-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 PHS 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. 



    Keywords:conflict of interest, outside activities report   Doc ID:33363
    Owner:Samuel L.Group:VCRGE and Graduate School
    Created:2013-09-13 14:02 CDTUpdated:2017-02-20 16:35 CDT
    Sites:VCRGE and Graduate School
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