Vanderbilt Law Review

Article Title

Duties to Subjects in Clinical Research


Carl H. Coleman


Physicians who conduct clinical research with human subjects face a profound conflict in professional roles. As physicians, they are committed to promoting the best interests of current patients. As researchers, however, their goal is to produce generalizable knowledge by studying the effects of interventions in broad cohorts of subjects.' Because producing generalizable knowledge often requires actions that are inconsistent with the best interests of the individuals enrolled in a study, these dual objectives often come into conflict. In such situations, where should the physician-researcher's loyalties lie? While this question has long been of interest to physicians and bioethicists, it has largely escaped the attention of lawyers. A recent wave of lawsuits against clinical researchers, however, is likely to change this situation. In evaluating these claims, courts will have to determine whether researchers owe subjects the same duty of care that physicians owe to their patients, or whether the researcher- subject relationship involves a different set of legal obligations-and, if it does, how those obligations should be defined.

At one extreme, courts might conclude that researchers have the same therapeutic obligations to subjects in clinical trials that physicians owe patients receiving ordinary medical treatment, a position advanced by several commentators in the medical and bioethics literature. According to this approach, researchers providing potentially therapeutic interventions in the context of clinical trials may not deviate from the best interests of individual subjects, because to do so would violate the physician's professional obligation to pro- mote the patient-subject's wellbeing.