Policies, Responsibilities, and Procedures
NEW POLICY EFFECTIVE AUGUST 23, 2012
Policy on Financial Conflicts of Interest in Federally Funded or Human Subjects Research
This policy applies to investigators engaging in—or proposing to engage in—federally funded research or any research involving human subjects. Generally, the UW-Madison Conflict of Interest Committee does not review or manage outside activities of individuals who do not hold a UW-Madison appointment. However, in accord with Federal regulations, when UW-Madison carries out federally funded research through subcontractors, subrecipients, or collaborators, the terms of the agreement between the parties will dictate whether this policy or the policy of the other party applies to the subrecipient investigator(s).
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This policy operates in conjunction with other UW-Madison policies on conflict of interest that apply to all faculty members (see Faculty Policies and Procedures, Chapter 8), members of the academic staff (see Academic Staff Policies and Procedures, Chapter 12), university officials (see policy governing Institutional Conflicts of Interest), and classified staff (see Classified Staff Policies and Procedures, Chapter 15). UW-Madison has adopted this policy and its attendant guidelines to incorporate the requirements set forth in the regulations promulgated by the US Department of Health and Human Services to promote objectivity in research (42 CFR Part 50, Subpart F and 45 CFR Part 94).
Additional information about this policy’s supporting processes and procedures is located in the Financial Conflicts of Interest Policy and Procedures Guidance Document.
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Generating new knowledge through research and translating that knowledge into applications that benefit society are important aspects of the mission of UW-Madison. The University encourages its faculty and staff to engage in research, to share their knowledge, and to promote the application of research results. Since these activities may result in financial gain to investigators, the UW-Madison, as a steward of public funds and the public trust, has the responsibility to identify those interactions that create potential conflicts of interest, and to manage those conflicts in a way that ensures the integrity of UW-Madison’s core activities and values.
According to the National Institutes of Health, a potential financial conflict of interest exists when an investigator has significant financial interests 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 to his or her immediate family. Others define conflict of interest situations in terms of obligations. Two activities may interact such that judgment in one activity may be, or may seem to be, influenced by the other activity. Together, these two definitions identify important elements of conflicts of interest. Conflicts of interest:
- represent a state of affairs, not behavior,
- frequently involve perceptions, and
- are judged by others, not by those directly involved.
Significant financial gains are considered to be of ultimate relevance in the current context for understanding conflicts of interest because money is recognized by the general public to be a potent motivator -- one that is easily understood, easily quantified, and discretionary. While the focus of conflict of interest considerations is financial gain, other relevant interests inherent in academia, including prestige, promotion, grants, and publications, can also potentially exert influence over research activities.Because financial conflicts of interest could contribute to bias in research reporting, influence judgment, reduce free exchange of research findings, pose a threat to research integrity, and compromise the protection of human subjects, UW-Madison has legal and ethical responsibilities to review and manage potential financial conflicts of interest in research.
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It is the policy of UW-Madison to ensure that research is not biased in its design, conduct, or reporting, and to ensure especially the protection of human subjects, by requiring disclosure and review of certain outside activities, and where appropriate, by managing and reporting significant financial interests that might present a real or perceived conflict of interest with an individual’s institutional responsibilities in such a manner as to appear to directly and significantly compromise the integrity of research.
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Investigators must undergo training on conflict of interest regulations, as well as UW-Madison’s policy and guidelines, prior to the expenditure of funds in any federally funded research or participation in human subjects research. Training must be renewed at least every four years thereafter. Investigators who come to UW-Madison from other institutions must undergo UW-Madison’s training prior to the expenditure of funds on a federally funded research project or participation in human subjects research. Should UW-Madison revise either its policy or guidelines concerning conflicts of interests in a manner that impacts the requirements of investigators, retraining will be necessary.
Investigators engaging in, or proposing to engage in, federally funded research or research involving human subjects are required to report all significant financial interests held by themselves or their immediate families that reasonably appear to be related to the investigator’s institutional responsibilities.
Significant financial interests are to be reported on Outside Activities Reports annually, and must be completed no later than the time of application for federally funded research. In addition, investigators must update their Outside Activities Reports within 30 days of acquiring or discovering a new significant financial interest.
Principal Investigators conducting research involving human subjects must submit information to IRBs in accordance with the guidelines.
Investigators receiving funding from the Public Health Service must also disclose the occurrence of travel reimbursed or sponsored by an outside organization within 30 days of such travel on Outside Activities Reports. 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, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
3. Review and Management of Relationships with Business Entities
UW-Madison has an obligation to manage any financial conflicts of interest as part of ensuring the integrity of research and protection of human subjects. To meet this obligation, the University directs the COI Committee to review all annual Outside Activities Reports, updates to such reports, and any protocol-specific Outside Activities Reports made by researchers conducting or proposing to conduct federally funded research or conducting research involving human subjects, to implement management plans, and to recommend appropriate actions to manage any financial conflicts of interest to UW-Madison IRBs.
An individual with certain financial interests in business entities cannot serve as an investigator on a human subjects protocol reviewed by a UW-Madison IRB if the entity or entities (a) sponsors the study, or (b) owns or licenses a technology tested in the study. Research participation is restricted when individuals have a significant financial interest in the entity or entities that meets or exceeds one of the following thresholds:
- Compensation of $20,000 or more in a calendar year from a business entity
- An ownership interest in a publicly traded business entity valued at $20,000 or more or a 5% or greater equity interest
- Any ownership interest in a privately held business entity
- A leadership position in a business entity (Leadership positions are positions with fiduciary responsibility, including senior managers (presidents, vice presidents, etc.) and members of boards of directors. Scientific advisory board membership is not a leadership position.)
An investigator may apply to the COI Committee for an exception to this prohibition based on compelling circumstances. If a UW-Madison IRB determines that a study poses no greater than minimal risks to subjects, investigators will normally be granted an exception to this prohibition without COI Committee review, unless a UW-Madison IRB determines that the investigator must apply to the COI Committee for an exception.
Additionally, individuals with the following financial interests must disclose the financial interests to human subjects research participants.
- Compensation of at least $5,000 but less than $20,000 in a calendar year
- An ownership interest in a publicly-traded company valued at least $5,000 but less than $20,000 and equal to less than 5% of the equity in the company
UW-Madison IRBs may determine that disclosure of financial interests would be inappropriate and not require it.
4. Data Analysis and Publication
Under no circumstances may a business entity limit the rights of an investigator to receive, analyze, or interpret any data generated as part of a research project. UW-Madison also prohibits restrictions on publication of research results, regardless of research outcomes. An investigator may agree to delay publication for the purpose of pre-publication review for a period consistent with that allowed by other UW-Madison policies (typically less than 30 days).
5. Students, Fellows, Trainees, and Other Research Workers
Significant financial interests may give rise to conflicts with an investigator’s responsibility to foster the academic and professional development of students, fellows, trainees, or other research workers. An investigator’s financial relationship with a business entity may not place restrictions on the activities of students or trainees. In particular, an investigator’s relationship may not prevent or inhibit students or trainees from meeting applicable UW-Madison degree requirements (e.g., completion and public defense of a thesis or dissertation).
Investigators must inform students engaged in research under their supervision of any financial interest which the investigator has in the research activity, including, but not limited to, financial arrangements involved in the direct support of the activity, agreements made by the unclassified staff member to obtain data for the research, or agreements concerning copyright or patent rights arising from the research.
6. Payments from Business Entities
UW-Madison prohibits payments to individuals from University accounts or directly or indirectly from business entities for particular research results or for research outcomes related to human subject protocols conducted at or through the UW-Madison. Further, neither investigators nor their immediate families may 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. The 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:
- The payment reasonably relates to costs incurred, as specified in research agreements between the sponsor and the UW-Madison.
- The payment reflects the fair market value of services performed.
- The payment is commensurate with the efforts of the investigator(s) performing the research.
More information on review and management is available in the guidelines that accompany this policy.
7. Public accessibility of information concerning individuals receiving funding from the Public Health Service
In accordance with Federal regulations, certain information about identified conflicts of interest of investigators who are named as senior/key personnel on research funded by the Public Health Service must be made available to the public.
8. Reports to Funding Agencies
As a condition of eligibility to receive grants or cooperative agreements for research from the Public Health Service, UW-Madison must provide reports on financial conflicts of interest to the appropriate PHS Awarding Component in the time and manner specified in the regulations and outlined in the Guidance Document.
9. Reconsideration of COI Committee Decisions
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. Investigators have twenty(20) business days from receipt of notification from the COI Committee or a UW-Madison IRB conveying the determination to request reconsideration. Individuals must make requests in writing and direct them to the Graduate School’s Associate Dean for Research Policy.
10. Ongoing Monitoring
UW-Madison monitors compliance with management plans on an ongoing basis.
Deliberate 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 and/or loss of privilege to serve as an investigator on federally funded research projects or human subjects research protocols.
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. In such situations, UW-Madison must follow the appropriate reporting and review processes detailed in the Guidance Document.
In any case in which the Department of Health and Human Services determines that a PHS-funded project of clinical research whose purposes is 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 shall be required to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentationsto indicate the existence of the FCOI.
12. 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 CFR 74.53(b) and 92.42(b) for different situations.
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The following definitions apply solely to the use of the terms in this policy and its attendant guidelines.
Business entity means 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 non-profit and for-profit entities.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information. (For definitions of intervention, interaction, and private information, see the Common Rule, 45 CFR 46.102).
Fiduciary means 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) means a significant financial interest that could directly and significant affect the design, conduct, or reporting of federally funded research or research involving human subjects.
Immediate family means an investigator’s spouse and dependent children.
Institutional responsibilities are 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 means 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 means taking 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 means that 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.
Research means 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 refers in this policy only to 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. Part 50, Subpart F.
Significant financial interest means all financial interests held by an investigator (and/or his or her immediate family), or by a business entity controlled or directed by the investigator or a member of his or her immediate family, that have monetary value, whether or not the value is readily ascertainable, subject to the following requirements:
- Remuneration (i.e. salary, consulting fees, honoraria, paid authorship, etc.) received from a publicly traded entity in the twelve months preceding disclosure, and the value of any equity interest (stock, stock option, or other ownership interest) in the entity at the date of disclosure that, when aggregated, exceed $5,000.
- Remuneration, (salary, consulting fees, honoraria, paid authorship, etc.) received from a non-publicly traded entity of greater than $5,000 in the twelve months preceding the disclosure.
- Any equity interest (i.e. stock, stock option, or other ownership interest) in a non-publicly traded entity.
- Royalty income from intellectual property rights not arising out of university employment, which are not assigned to organizations created to manage such rights on behalf of the University of Wisconsin-Madison.
- Reimbursed or sponsored travel related to institutional responsibilities that is not reimbursed or sponsored by a government agency, a U.S. university, an academic teaching hospital, a medical center, or a research institute that is affiliated with a U.S. university.
- 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.
Exceptions. Significant financial interests do no tinclude the following:
- Salary, royalties, or other remuneration received from UW-Madison, the University of Wisconsin Medical Foundation, or the 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 institutoinal 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 refers to an entity or individual named on a subcontract from UW-Madison on a federally funded award or human subjects research proposal.
Technology means any diagnostic, therapeutic, medical, or surgical procedure and any process, method, compound, drug, or device.