Financial Conflicts of Interest in Research

Layout for printing
Policy Number:
UW-4001
Responsible Office:
Office of Research Policy and Integrity

University Policy

Rationale/​Purpose:

Unmanaged, significant financial interests that might present a real or perceived conflict of interest with an individual's university responsibilities can compromise the objectivity and integrity of research. To promote research integrity as well as meet federal requirements, UW–Madison requires the disclosure, review, and, as needed, management of outside activities to help ensure that research and research outcomes are free from bias.

Definitions:
Business Entity
Any corporation, partnership, proprietorship, firm, enterprise, franchise, association, trust, or legal entity other than an individual or body politic. This term also includes any entity acting as the agent of a business entity (e.g., a contract research organization). Business entities include both nonprofit and for-profit entities.
Conflict of Interest (COI) Committee
Independent committee charged with reviewing and managing the outside activities of federally funded investigators and those engaged in human subjects research.
Fiduciary
A person holding the character of a trustee, or a character analogous to that of a trustee, in respect to the trust and confidence involved in it and the scrupulous good faith and candor which it requires. A person having duty, created by his undertaking, to act primarily for another's benefit in matters connected with such undertaking.
Financial Conflict of Interest (FCOI)
A significant financial interest that could directly and significantly affect the design, conduct, or reporting of federally funded research or research involving human subjects.
Human Subject
A living individual about whom an investigator (whether professional or student) conducting research obtains information or biospecimens through intervention or interaction with the individual and uses, studies or analyzes the information or biospecimens; or obtains uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (For definitions of intervention, interaction, and private information, see the Common Rule, 45 C.F.R. § 46).
Immediate Family
For purposes of this policy, an investigator's spouse and dependent children.
Institution
Any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for, or that receives PHS research funding.
Institutional Responsibilities
An investigator's professional responsibilities on behalf of UW–Madison, including research, research consultation, instruction, professional practice, extension/outreach, administrative activities, and institutional committee memberships.
Investigator
The principal investigator or project director and any individual (e.g., faculty member, staff member, student, fellow, or trainee, including those with zero percent appointments, or, as determined by inter-institutional agreements, collaborators or subrecipient awardees not employed by UW–Madison) who is responsible for the design, conduct, or reporting of research involving human subjects, federally funded research, or research proposed for federal funding.
Manage
Take action to address a conflict of interest, which can include reducing or eliminating the conflict of interest, to ensure to the extent possible that the design, conduct, and reporting of research will be free from bias.
Minimal Risk
The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Outside Activities Report (OAR)
For the purposes of this policy, the institutional report filed by investigators to report their outside financial interests.
Public Health Service (PHS)
A federal agency within the U.S. Department of Health and Human Services as defined in 42 C.F.R. § 50.
Research
A systematic investigation designed to develop or contribute to generalizable knowledge. The term encompasses basic and applied research (e.g., that which results in a published article, book or book chapter) and product development (e.g., a diagnostic test or a drug).
Senior/Key Personnel
For the purposes of this policy, refers to the individuals engaged in federally funded research and means the Principal Investigator and any other person identified as senior/key personnel by UW–Madison in the grant application, progress report, or any other report submitted to the Public Health Service by UW–Madison under 42 C.F.R. § 50, Subpart F.
Significant Financial Interest (SFI)

A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities:

  • With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
  • With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
  • Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
  • 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 investigator receives compensation for such service.

Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 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.

Significant Financial Interest does not include the following:

  • Salary, royalties, or other remuneration received from UW–Madison, the University of Wisconsin Medical Foundation, or the Veterans Administration (VA).
  • 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.
  • Income from investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not control the investment decisions made in these vehicles.
  • 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.
  • 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.
  • Travel related to institutional responsibilities that is reimbursed or 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.
Subrecipient
An entity or individual named on a subcontract from UW–Madison on a federally funded award or human subjects research proposal.
Scope:

This policy applies to investigators engaging in or proposing to engage in federally funded research or any research involving human subjects. It also applies to individuals who do not hold a UW–Madison appointment, when, in accord with Federal regulations, UW–Madison carries out federally funded research through subcontractors, subrecipients, or collaborators where the terms of the agreement dictate that UW-Madison is the responsible party.

Policy:

  1. Relationship to Similar Policies and Documents

    1. This policy operates in conjunction with other UW–Madison policies on conflict of interest that apply to all faculty members (e.g., UW-808 Faculty Policies and Procedures Chapter 8 - Faculty Rights and Responsibilities), members of the academic staff (e.g., UW-712 Academic Staff Policies and Procedures: Chapter 12 - Outside Activities and Conflicts of Interest), university officials (e.g., UW-4002 Institutional Conflicts of Interest), and university staff (see Regent Policy Document 20-22, Code of Ethics), as well as UW-1075 Conflict of Commitment.

    2. UW–Madison has adopted this policy and its attendant guidelines to incorporate the requirements set forth by the US Department of Health and Human Services (42 C.F.R. § 50, Subpart F and 45 C.F.R. § 94) the National Science Foundation (NSF 510), and other federal funding agencies to promote integrity and objectivity in research.

    3. Research involving human subjects, regardless of funding source, requires disclosure, review, and, when appropriate, management of Significant Financial Interests (SFI). In these circumstances, this policy works in conjunction with UW-4145 Institutional Review Board (IRB) Review and HRP-055, SOP: Financial Conflicts of Interest, with a primary focus on promoting research integrity and ensuring that research is free from bias due to financial conflicts of interest.

    4. Additional information about this policy's supporting processes and procedures is in the Financial Conflict of Interest Policy and Procedures: Guidance Document.

  2. Governance

    1. Institutional Official
      1. The associate vice chancellor for research policy and integrity is the institutional official for all research financial conflicts of interest defined in this policy and is responsible for the following.
        1. Oversees and leads the Conflict of Interest (COI) Office.
        2. Stewards the Outside Activities Reporting (OAR) database that supports this policy as well as UW-4002 Institutional Conflicts of Interest and UW-1075 Conflict of Commitment.
        3. In conjunction with schools and colleges, monitors compliance with approved management plans and acts to address non-compliance.
        4. As required by federal regulations (e.g., Public Health Service), ensure that certain information about identified conflicts of interest of investigators who are named as senior/key personnel on research is available to the public.
        5. As a condition of eligibility to receive federal grants or cooperative agreements for research (e.g., Public Health Service), provides for reports on financial conflicts of interest to sponsors in the time and manner specified in the regulations and outlined in the Procedural Guidance Document.
      2. When required, the institutional official will also notify funding agencies of unmanageable conflicts of interest as outlined in the Procedural Guidance Document.
    2. Conflict of Interest (COI) Committee
      1. The COI Committee or members thereof may, at the request of the institutional official, be asked to review and/or advise on specific research financial conflicts of interests.
      2. Membership: Voting members will be 12-18 tenured faculty members appointed by the chancellor to three-year, renewable terms. Non-voting, ex officio consultants will be appointed at the discretion of the vice chancellor for research and will minimally include representation from the COI office, the Institutional Review Boards (IRB), and the Office of Legal Affairs.
      3. The COI Committee will follow a simple majority standard and Robert’s Rules of Order unless modified by committee vote.

  3. Requirements

    1. Training
      1. Investigators must complete training on conflict of interest regulations, as well as UW–Madison's policy and guidelines, prior to any of the following:
        1. The expenditure of funds for any federally funded research,
        2. Engaging in federally funded research, or
        3. Engaging in human subjects research.
      2. Training must be renewed at least every four years thereafter, depending on an investigator’s funding and/or participation in human subjects research.
      3. Investigators who come to UW–Madison from other institutions must undergo UW–Madison's training as outlined in this policy.
      4. Immediate retraining is necessary when UW–Madison revises its policy and/or guidelines concerning conflicts of interest in a manner that impacts the requirements of investigators. 
    2. Disclosure
      1. Investigators must report all significant financial interests held by themselves or members of their immediate family that reasonably appear to be related to the investigator's institutional responsibilities.
      2. Significant financial interests must be reported on OARs annually and must be completed no later than the time of application for federally funded research. In addition, investigators must update their OARs within 30 days of acquiring or discovering a new significant financial interest or engaging in an uncompensated reportable activity, such as becoming a member of a board of trustees.
      3. Investigators conducting research involving human subjects must submit information to IRBs in accordance with IRB requirements.
      4. A collaborator must disclose interests in their institution (e.g., remuneration or equity) to the UW-Madison COI program for review and management when:
        1. The collaborator is employed at another institution and following that institution’s PHS compliant FCOI policy, and
        2. The collaborating institution is a sponsor of the study or owns or licenses a technology used in the study, and
        3. The study is reviewed by a UW-Madison IRB or includes a proposal that the collaborator interacts with UW-Madison participants.
      5. Investigators receiving funding from federal agencies must also disclose the occurrence of travel reimbursed or sponsored by an outside organization, including all foreign entities.
        1. Per NIH Guide Notice NOT-OD-13-004, investigators' initial disclosures must include all reimbursed and sponsored travel over the previous twelve-month period.
        2. After the initial disclosure, investigators are required to update their Outside Activities Reports within 30 days of such travel.
        3. This travel disclosure requirement also applies to reimbursed or sponsored travel by members of an Investigator's immediate family.
        4. This disclosure requirement includes all foreign entities, including academic institutions, but does not apply to travel that is reimbursed or sponsored by the following:
          1. United States Federal, state, or local government agency,
          2. United States institution of higher education,
          3. United States academic teaching hospital or a medical center,
          4. Research institute that is affiliated with a United States institution of higher education.
    3. Review and Management of Relationships with External Entities
      1. The COI Committee will review all OARs of federally funded investigators and those engaged in human subjects research to determine whether:
        1. Any Significant Financial Interest (SFI) relates to federally funded research, and
        2. Any SFI related to federally funded research constitutes an FCOI.
      2. If the COI Committee determines that an FCOI appears to exist, a management plan is required. If applicable, the COI Committee will recommend, in writing, appropriate actions to manage the FCOI.
        1. This review process must be completed within 30 days prior to the expenditure of funds, within 60 days of a new SFI being disclosed, or within 60 days of an SFI that was not disclosed within 30 days.
        2. The COI Committee may consider the stage of the research, its commercial potential, magnitude of risk to participants in studies, and other factors when deciding about the existence of a financial conflict of interest.
        3. Management plan conditions and restrictions may include but are not limited to disclosure, appointment of an independent monitor, limitations on participation on human subjects protocols, and reduction or elimination or the financial interest.
      3. UW Madison faculty, staff, and students with a management plan for an external entity cannot serve as an investigator on a human subjects protocol where an IRB has determined that it poses greater than minimal risk to research participants if the managed entity sponsors the study, or owns or licenses a technology used in the study.
        1. An investigator may apply to the COI Committee for an exception to this prohibition based on compelling circumstances.
        2. The COI Committee may consult with the reviewing IRB prior to or while considering the exception request.
        3. If a reviewing IRB determines that a study poses no greater than minimal risks to subjects, investigators will generally be permitted to participate in the study subject to limitations set forth in the conflict of interest management plan.
        4. A reviewing IRB has the authority to impose additional requirements that the IRB determines necessary to protect research participants.
      4. An individual who is engaged in human subjects research in collaboration with UW-Madison, but is not employed by or enrolled at UW-Madison, cannot serve as an investigator on a human subjects protocol reviewed by a UW-Madison IRB or involving interaction with UW-Madison participants if they have significant financial interest in an entity that sponsors the study, or owns or licenses a technology used in the study, without a management plan issued by the UW-Madison COI Committee.
      5. UW–Madison prohibits payments to individuals from university accounts or, directly or indirectly, from business entities for particular research results, or research outcomes related to human subject protocols conducted at or through UW–Madison.
      6. Investigators and their immediate families may not receive any personal incentives from university accounts or, directly or indirectly, from business entities, such as recruitment incentives, performance incentives, fellowships, or other research support, except through an agreement entered into by the university for sponsored research.
      7. UW–Madison only permits payments for subject enrollment, or for the referral of potential subjects to human subjects studies, when all of the following are present: 
        1. The payment reasonably relates to costs incurred, as specified in research agreements between the sponsor and the UW–Madison.
        2. The payment reflects the fair market value of services performed.
        3. The payment is commensurate with the efforts of the investigator(s) performing the research.
      8. Reconsideration of COI Committee Decisions
        1. An investigator may request reconsideration of any COI Committee determination that affects his or her ability to participate, or conditions of participation, in federally funded or human subjects research.
        2. Such requests must be in writing and received by the COI Office. The institutional official must respond within 30 business days.
    4. Noncompliance
      1. Investigators not in compliance with this policy or a management plan may be required to undergo additional training and supervisory and/or disciplinary action as allowable under UW-Madison policies.
      2. Misrepresentation of information to the COI Committee or an IRB, or failure to comply with the terms of this policy or a management plan, may result in sanctions including disciplinary actions up to and including termination and/or loss of privilege to serve as an investigator on federally funded research projects or human subjects research protocols.
      3. In the case of research funded by the Public Health Service, instances of noncompliance trigger additional obligations of UW–Madison to the PHS Awarding Component, including conducting a retrospective review.
      4. In such situations, UW–Madison must follow the appropriate reporting and review processes detailed in the Procedural Guidance Document.
      5. When the United States Department of Health and Human Services determines that PHS-funded clinical research intended to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an investigator with a financial conflict of interest that was not managed or reported as required by federal regulations, the investigator must disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations to indicate the existence of the FCOI.
    5. Records Retention
      UW–Madison must maintain records of all financial disclosures and all actions taken with respect to any conflict of interest covered by this policy for at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 C.F.R. § 75.361.

  4. Organizational Conflicts of Interest (OCI)

    1. Responsibilities of the Office of the Vice Chancellor for Research (OVCR)
      1. When a contract or agreement invoking OCI terms is presented to the university, the OVCR Office of Research Policy and the department, institute, or center where the work will be done will develop a conflict-of-interest attestation plan that will identify:
        1. Participants in the proposed work.
        2. Competitive contracts or agreements already within the department, institute or center.
        3. Training needed for participants in university- and unit-level procedures for the handling of sensitive and proprietary information.
        4. Existing contracts or agreements that may generate competitive advantage vis-à-vis other parties through unequal access to information, may impair the objectivity of work carried out on the proposed or existing contracts or agreements, or may provide an opportunity to contribute to procurement rules for future projects.
        5. Needs for participant recusal from such competitive contracts.
        6. Information to be included in non-disclosure agreements for participants.
      2. The attestation plan must be presented to all participants in the contract or agreement by representatives of the OVCR Office of Research Policy and leadership of the department, institute or center for review and signature before work can proceed.
      3. Copies of the signed attestation will be provided to the requesting sponsor, OVCR Office of Research Policy, the department, institute or center, and the participant.
      4. The leadership of the department, institute, or center will provide a bi-annual report on status of compliance with the attestation plan to the OVCR Office of Research Policy.
      5. Ongoing after the enactment of an OCI attestation plan, the leadership of the department, institute, or center will provide assessments of newly proposed contracts and their relevance to existing attestation plans. If potential OCI concerns are identified, the leadership will enact additional measures to prevent circumstances that could be perceived to inhibit University of Wisconsin–Madison from providing impartial assistance or advice to research sponsors, impair its objectivity in performing research, or give an unfair competitive advantage in competition for Government funding.
    2. Responsibilities of Faculty, Academic Staff, and Limited Appointees
      1. In accordance with Wis. Admin. Code, UWS § 8, faculty, academic staff, and limited appointees are prohibited from using their university position for personal or private benefit in a manner contrary to the interests of the Universities of Wisconsin and requires the disclosure of potential conflicts, including those that may generate organizational conflicts of interest.
      2. Faculty, Academic Staff, and Limited Appointees must disclose outside professional activities that may result in an OCI. These activities fall under broader institutional considerations for reporting and managing professional conflicts of interest described in the policies cited above. These activities include, but are not limited to, work done on behalf of the United States government involving:
        1. Contracts to provide scientific, engineering, and technical direction;
        2. Serving as an advisor and providing analysis, assistance, or evaluation services;
        3. Preparing specifications and work statements for funding opportunities;
        4. Access to proprietary, confidential, or sensitive data.
      3. These activities may be undertaken in someone’s UW–Madison capacity, as an independent contractor, or as a volunteer. If these activities are conducted in a person’s outside capacity, disclosure of compensation received (if any) and time committed to these outside professional activities must be:
        1. Submitted via the Outside Activities Reporting portal.
        2. Disclosed to Research and Sponsored Programs.
        3. Disclosed as part of a grant application or contract involving a federal sponsor of research.
      4. In the event a potential OCI is identified that is related to proposed or ongoing research at the university, a representative of the OVCR will work with Research and Sponsored Programs, the government’s contracting officer/program manager, the impacted UW–Madison personnel and their departments and others as necessary to neutralize or mitigate the OCI.
      5. Management of the OCI may include participant recusal from certain activities, maintaining confidentiality of data, and/or review of work by an independent third party, or others.
Related UW-Madison Policies:
Related UW–Madison Documents, Web Pages, or Other Resources:
External References:

Policy Administration

Approval Authority:
Senior Associate Vice Chancellor
Policy Manager:
Associate Vice Chancellor for Research Policy and Integrity
Contact:
Conflict of Interest Compliance Program -- Conflict of Interest Compliance Program, coiprogram@research.wisc.edu
Effective Date:
08-23-2012
Revised Dates:

11-24-2020, 01-22-2021, 08-28-2023, 10-25-2023, 05-07-2025

Reviewed Dates:

05-07-2025

Retrieved:
06-15-2025 23:10:39