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.
The following definitions apply solely to the use of the terms in this policy and its attendant guidelines.
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).
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 Conflict of Interest Program), and university staff (see Regent Policy Document 20-22, Code of Ethics). 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 (42 C.F.R. § 50, Subpart F and 45 C.F.R. § 94) and the National Science Foundation (NSF 510) to promote objectivity in research.
Additional information about this policy's supporting processes and procedures is located in the Financial Conflict of Interest Policy and Procedures: Guidance Document.
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:
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.
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 federal agencies must also disclose the occurrence of travel reimbursed or sponsored by an outside organization, including all foreign entities. Per NIH Guide Notice NOT-OD-13-004, Investigators' initial disclosures must include all reimbursed and sponsored travel over the previous twelve-month period. After the initial disclosure, Investigators are required to update Outside Activities Reports within 30 days of such travel. As with other significant financial interests, this travel disclosure requirement also applies to reimbursed or sponsored travel by members of an Investigator's immediate family. This disclosure requirement includes all foreign entities, including academic institutions, but does not apply to travel that is reimbursed or sponsored by a U.S. Federal, state, or local government agency, a U.S. institution of higher education, a U.S. academic teaching hospital or a medical center, or a research institute that is affiliated with a U.S. institution of higher education.
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 reviewing IRBs. 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 in preparation 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 an 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 when the significant financial interest could directly and significantly have a material effect on the design, conduct, or reporting of research. Reviewers may consider the stage of the research, its commercial potential, magnitude of risk to participants in studies, and other factors when making a determination about the existence of a financial conflict of interest.
An individual with a management plan for an external entity cannot serve as an investigator on a human subjects protocol considered by a reviewing IRB to pose greater than minimal risk to research participants if the managed entity (a) sponsors the study, or (b) owns or licenses a technology used in the study.
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 investigator to obtain data for the research, or agreements concerning copyright or patent rights arising from the research.
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 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.
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 presentations to indicate the existence of the FCOI.
11-24-2020, 01-22-2021
