it recommends that medical centers develop policies to provide clear guidelines to clinical researchers.

Sanctions

Research sponsors can withdraw funding or apply penalties when their rules regarding conflict of interest are broken. Institutions also sometimes apply sanctions. For example, the Harvard University Faculty of Medicine's approach to conflicts of interest specifies the following sanctions in rough order of severity: formal admonition; inclusion in a personnel file of a letter from the Office of the Dean that an individual's good standing as a member of the faculty has been called into question; ineligibility for grant applications, institutional review board approval, or supervision of graduate students; nonrenewal of appointment; and dismissal from the faculty.

SUMMARY

Two models provide the main approaches for managing conflict of interest. A prohibition model is based on a presumption against relationships that might present a conflict; a "disclosure and peer review" model rests on presumption that such relationships are unavoidable but manageable. Although the models differ in their underlying presumptions, in where the line is drawn between prohibition and management, and in the means used to deal with conflicts of interest, both models are likely to use one or more of the following mechanisms for dealing with conflict: disclosure, financial distancing, self-regulation, defining categories of acceptable activities, implementing oversight of those activities, defining categories of unacceptable activities, and implementing prohibitions and sanctions. Chapter 6 considers these procedures as applied to PORTs.



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