Trust Us to Make a Difference: Ensuring Public Confidence in the Integrity of Clinical Research


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Abstract

Investigator's and institutions' financial conflicts of interest in clinical research raise serious questions about the objectivity of such research, the safety of human subjects, and the threat to public trust in the integrity of clinical research. Yet the author makes clear that a conflict of interest is a state of affairs, not a behavior, and therefore not automatically a manifestation of improper actions. Indeed, conflicts of interest are quite common in complex settings such as those of academic medicine, and usually pose no problem, both because of the safeguards already in place and the integrity of most researchers. But it is clear that both non-financial conflicts of interest (e.g., career advancement, peer recognition, garnering grants and publications) and financial ones are double-edged: they can motivate individuals to do their best work but also can compromise judgment and undermine objectivity. In particular, conflicts of interest involving money, especially money from external sources, warrant special, targeted safeguards. And whether or not such conflicts of interest have actually created significant problems, academic medicine risks great peril if its leaders fail to respond to the growing perception that such problems exist.To foster public trust, the public needs to be better educated about how, with proper safeguards, limited financial incentives in the conduct of clinical research can benefit everyone. In addition, safeguards against the downsides of such financial incentives must be visibly strengthened. The author offers eight suggestions for what academic medicine's leaders might do in this regard (comply with existing full-disclosure requirements; establish principles governing institutional conflicts of interest; etc.). He closes by reiterating that the pursuit of clinical research depends entirely on the ability and willingness of the research community to merit public trust.

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