Conflict of Interest and Clinical Research Policy

Any individual* or family member of the individual directly involved in the conduct of research studies involving human subjects should have at most a minimal ($10,000), if any, financial interest in a company that is sponsoring the research or owns or licenses the technology being studied**.

Washington University in St. Louis adopts the presumption that, in the absence of compelling circumstances, a financially interested individual may not conduct human subjects research.

However, an investigator will have the opportunity present compelling reasons and circumstances to justify exceptions to this general rule. Compelling circumstances may include, but are not limited to, the nature of the research, the magnitude of the interest or the degree to which it is related to the research, the extent to which the interest could affect the research, and the degree of risk to the human subjects involved that is inherent in the research protocol. Any exceptions to this conflict of interest policy must be approved in writing by the appropriate disclosure review committee, the vice chancellor for research, and the dean of the appropriate school.

This policy is not meant to include financial arrangements with companies that occur either prior to the initiation of a sponsored study or after its publication; what should to be avoided are financial relationships during the course of the study whose value might be influenced by the outcome. Examples of technologies include, but are not limited to pharmaceuticals, procedures or devices. Financial relationships covered by this policy which need to be disclosed include: consulting; speaking or other fees; honoraria; gifts; licensing revenues; other research agreements; equity interests, including stock options and expectations of receiving equity interests; and other fees or compensation received from companies. The maximum aggregate amount received by the individual from all such financial relationships should not exceed $10,000 in any 12-month period, including the current value of equity interests owned by the individual in the company sponsoring the research. Special consideration must be given to ownership of stock options. Stock options granted by the company supporting the research, regardless of value, must be disclosed to the Disclosure Review Committee to determine risk and appropriate management strategies.

*e.g., faculty, staff, student, department/division chair and other co-investigators

**This policy does not restrict financial relationships with a company before the research is undertaken or after the publication of the of the research results.

Effective December 18, 2001