It is often claimed that a clinical investigator may ethically participate (e.g., enroll patients) in a trial only if she is in equipoise (if she has no way to ground a preference for one arm of the study). But this is a serious problem, for as data accumulate, it can be expected that there will be a discernible trend favoring one of the treatments prior to the point where we achieve the trial's objective. In this paper, I critically evaluate Benjamin (...) Freedman's 'clinical equipoise' solution to this dilemma. I argue that Freedman actually puts forth at least two distinct contrasts - one in terms of community vs. individual equipoise, and another concerning clinical vs. theoretical equipoise - and that neither of them resolves the dilemma. I then make a proposal for a more adequate account of how to think about the circumstances under which entering subjects in trials would be justified - a 'sliding-scale equipoise' that arises out of a discussion of patients' values. (shrink)

: The "difference position" holds that clinical research and therapeutic medical practice are sufficiently distinct activities to require different ethical rules and principles. The "similarity position" holds instead that clinical investigators ought to be bound by the same fundamental principles that govern therapeutic medicine—specifically, a duty to provide the optimal therapeutic benefit to each patient or subject. Some defenders of the similarity position defend it because of the overlap between the role of attending physician and the role of investigator in (...) a research trial. This overlap is maximal when the same physician occupies both roles with respect to a particular patient-subject. We address the ethical tensions inherent in that role conflict and argue that the tensions are real but manageable. The difference position provides a sound ethical framework within which to manage those tensions, while the similarity position is unsatisfactory because it seeks to deny the existence of the tensions. (shrink)

It is commonly believed in research ethics that some form of equipoise is a necessary condition for justifying randomized clinical trials, that without it clinicians are violating the moral duty to do what is best for the patient. Recent criticisms have shown how complex the concept of equipoise is, but often retain the commitment to some form of equipoise for randomization to be justified. This article rejects that claim. It first asks for what one should be equally poised (scientific or (...) clinical equipoise), then asks who should be equally poised (scientist, clinician, or subject), and finally asks why any of these players need be equally poised between treatment options. The article argues that only the subject's evaluation of the options is morally relevant and that even the subject need not be equally poised or indifferent between the options in order to volunteer for randomization. All that is needed is adequately informed, free, and unexploited consent. It concludes equipoise is irrelevant. (shrink)

Clinical research employing the randomized clinical trial has, traditionally, been understood to pose an ethical dilemma. On the one hand, each patient ought to get the treatment that best meets her needs, as judged by the patient in consultation with her doctor. On the other hand, the method most helpful to advancing our understanding about what treatments are indeed best able to meet patient needs is the randomized trial, which necessitates that each patient's care is decided not by physician judgment (...) or patient choice but instead by random assignment. The tension can be described as a conflict between the interests of individual patients who are sick today, and the interests of the group of people who will become sick in the future and would benefit from advances in medical understanding. How one ought to balance these important and often competing interests is an important ethical question that resists easy resolution. (shrink)