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Understanding and Managing Conflicts of Interest

Posted on May 17, 2006

J. Bruce Smith (bio) defines conflicts of interest and shares how to handle them.


Q: What is a conflict of interest? Is it the same as a conflict of commitment?
A: A conflict of interest may exist when financial or other personal considerations have the potential to compromise or bias professional judgment or objectivity. Having a conflict of interest is not, however, by itself a sign of misconduct. Conflicts of interest can be commonplace in some settings and may involve institutions as well as individuals. In fact, the Bayh-Doyle Act of 1980 encouraged cooperation between industry and academia by allowing inventions made with federal funding to be licensed to industry and brought to the marketplace.

A conflict of commitment specifically refers to situations where the demand for a person's time and resources from multiple commitments jeopardize the duties and responsibilities associated with one of those commitments. An example of this would be outside consulting activities interfering with the duties of one's primary employment.

Q: Are there regulations to define what constitutes a financial conflict of interest?
A: Federal regulations defer, in part, to institutional definitions of conflicts of interest, and those standards can vary quite a bit. The usual disclosure thresholds include more than 5% equity ownership interest in a company; more than $10,000 investment or other financial interest; acceptance of gifts, gratuities, or entertainment; and/or appointment as a company's manager, scientific advisor, or board member.

Q: What are the consequences of an unmanaged conflict of interest?
A: If conflicts of interest are not handled properly, research participants can be at risk for increased harm. Unintentional bias may lead to activities such as subtle coercion of potential participants, overlooking or failing to report adverse events, and skewing the participant selection process. In addition, conflicts of interest can decrease public confidence in the integrity of scientific research and negatively impact people beyond the investigator and parent institution.

Q: How do I handle a conflict of interest?
A: When possible, nullify the potential conflict by selling related financial interests and/or severing relationships that create actual or potential conflicts. If a conflict cannot be avoided, then you must disclose the conflict. Conflicts should be reported at least annually in accordance with your institution's regulations, and new potential conflicts of interest must be reported as they arise. In addition to reporting to your home institution, you should also report conflicts of interest to journals at the time of manuscript submission and funding agencies. In addition to disclosure, you can manage the potential for conflict by having your research monitored by independent reviewers. Conflicts should also be disclosed, in general terms, in consent forms. For example, "The principal investigator for this study serves on the scientific advisory board of/is a paid lecturer for/etc. MegaPharma, Inc., the sponsor of this research."

Based on presentation at The Research Coordinator: Strategies for Promoting Integrity in Clinical Research, June 2005, Bryn Mawr, PA, and personal communication with the researcher in May 2006.

 

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