Conflict of Interest
Federal guidelines require the IRB to assure there are no conflicts of interest in research projects that could affect human subject participation and protection.
21 CFR 54.1 - 21 CFR 54.2 - 21 CFR 54.4 - 21 CFR 312.64(d) - 21 CFR 812.110(d)
Researchers are required by Regents and IRB policy to disclose any potential conflicts involved in the conduct of their research with human subjects.
Specific Types of Conflict of Interest
Conflict of Interest is not just when financial interests are involved, but rather any circumstance that could result in perception of undue influence or coercion would constitute a potential conflict of interest. For example, if a researcher wishes to recruit a subject who is also a student, an employee, a colleague or a subordinate of the researcher, the potential for coercion exists. Though the researcher may be very careful to avoid potentially coercive behavior, the very nature of the relationship with the subject can create the appearance of coercion. For this reason, researchers should avoid using their own students or employees as subjects. Researchers who do wish to include these groups as subjects must make special considerations due to this inherent conflict.
- A researcher or family member participating in research on a technology, process or product owned by a business in which the faculty member holds a financial interest;
- A researcher participating in research on a technology, process or product developed by that researcher;
- A researcher or family member assuming an executive position in a business engaged in commercial or research activities related to the researcher’s University responsibilities;
- A researcher or family member serving on the Board of Directors of a business from which that member receives University-supported Sponsored Research Support;
- A researcher receiving $10,000 or more in consulting income from a business that funds his or her research;
- A researcher who wishes to recruit a subject who is also a student, an employee, a colleague or a subordinate of the researcher.
Reasoning Behind the Regulations
Before agreeing to participate in research, potential subjects must be made aware of the risks and benefits involved. If a researcher has for example, a stake in a company that might be affected by the outcome of the research, this fact must be disclosed to subjects as it affects the balance of risks and benefits. Such disclosure is also often necessary to avoid accusation of inappropriate withholding of information. The University prohibits activities in which an actual conflict of interest occurs. If an individual identifies activities or interests that have the potential for a conflict of interest, the University can work with the appointee to manage the potential conflict of interest whenever possible. The University’s conflict management process endeavors to eliminate or mitigate potential conflicts so that they do not become actual conflicts of interest.
How It Works - Research
Regents Policies on Individual Conflict of Interest Policy or Institutional Conflict of Interest Policy require University faculty and staff to report external professional activities and business and significant financial interests related to his or her University activities by submitting a REPA (Report of External Professional Activities) at least once per year. Faculty and staff should also file a REPA when substantial changes in business or financial interests occur, when an activity that presents a potential conflict of interest is anticipated, or when submitting an application for research support or technology transfer, submitting research protocols to the IRB, or receiving financial contributions. More information on reporting is available on the Web site of the Office of Regulatory Affairs at http://www.research.umn.edu/regaffairs/conflict/index.html
As part of the informed consent process, potential subjects must be made aware of any interest the researcher has that may affect the decision to participate.
How it Works - IRB
The IRB application forms require a researcher to indicate whether there is a conflict of interest, if that conflict has been disclosed to the proper entities, and if there is a management plan in place regarding the conflict. The IRB works in conjunction with the Conflict Management Review Committeee which serves in an advisory capacity, in interpreting conflict of interest and assessing the need for disclosure. If a management plan is created, the investigator must provide the IRB with a copy of the plan. In the assessment of risks and benefits, the IRB must determine if it is necessary that such a conflict be disclosed to subjects in the consent form. Disclosure alone may not be sufficient—the IRB will make the final determination of what is required to assure that subjects are protected and fully informed.
Special Cases - Drugs and Devices
The FDA may consider clinical studies and the resulting data inadequate if, among other things, appropriate steps have not been taken in the design, conduct, reporting and analysis of the studies to minimize bias. One potential source of bias in clinical studies is a financial interest of the clinical investigator in the outcome of the study.
Gifts to Researchers
Under Minnesota law, practitioners with authority to prescribe drugs are prohibited from accepting gifts from drug manufacturers and wholesale distributors valued at more than $50 per year. There are certain exceptions including payments for consulting and honoraria. Consistent with this law and University policy generally, researchers may not accept gifts, such as findersfees or recruitment bonuses, paid by research sponsors or others to the researcher personally in connection with University research activity. This prohibition is reflected in IRB application forms.
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