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  1. FDA Basics

What is a conflict of interest?

A conflict of interest is of a financial nature. FDA reviews all financial interests related to the particular topic of a meeting to determine if a conflict exists. If the financial interest is not related to the meeting topic, a conflict of interest may not exist. In order to be considered a financial conflict of interest, FDA determines whether the discussion at the meeting or outcomes of the meeting will have a direct and predictable effect on the individual’s interest.

For example, a researcher employed at a major university is appointed to serve on an advisory committee that will evaluate the safety and effectiveness of a new medical device to regulate arrhythmic heartbeats. The device is being developed by a company that also has contracted with the researcher’s university to assist in developing another medical device related to kidney dialysis. There is no evidence that the advisory committee's determinations concerning the medical device under review will affect the company’s contract with the university to develop the kidney dialysis device. The researcher may participate in the committee's deliberations because those deliberations will not have a direct and predictable effect on the financial interests of the researcher or his or her employer.

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