Duties to Subjects in Clinical Research

Abstract:     
Clinical trials pose a fundamental conflict between physicians' commitment to protecting the medical best interests of current patients and the goal of producing scientific knowledge for the potential benefit of patients in the future. While this conflict has long been of interest to physicians and bioethicists, it has largely escaped the attention of legal scholars. That is likely to change, however, as a growing wave of litigation brought by individuals injured in clinical trials will force courts to determine the nature of researchers' legal obligations to subjects. In making these determinations, this Article argues, courts must recognize that medical research is fundamentally different from ordinary clinical treatment, in terms of both its underlying purposes and its methodology. In light of these differences, requiring researchers to adhere to the same therapeutic obligations as treating physicians, as some commentators have advocated, would be tantamount to a virtual prohibition of clinical trials, an outcome that courts should reject. At the same time, it would be a mistake to hold that researchers have no duty whatsoever to protect the medical best interests of individual subjects. This Article therefore develops an alternative framework for conceptualizing researchers' duties to subjects, using principles governing conflicts of interests in fiduciary relationships a starting point for analysis. These principles demonstrate that it is possible to protect vulnerable individuals in dependent relationships without absolutely precluding the pursuit of goals that potentially conflict with those individuals' overall welfare. Importantly, however, consent is generally insufficient to justify deviations from the pursuit of the best interests of the beneficiary in a fiduciary relationship; instead, the law imposes additional requirements to ensure that such deviations are objectively fair. After explaining why a similar approach makes sense in the context of clinical trials, this Article provides a specific framework for using those principles to resolve conflicts between the pursuit of scientific knowledge and subjects' medical needs.

Keywords: Human subject, research, duty, fiduciary

Accepted Paper Series