Reasonable People,Double Jeopardy,and Justice

The equipoise requirement in clinical research demands that, if patients are to be randomly assigned to one of two interventions in a clinical trial, there must be genuine doubt about which is better. This reflects the traditional view that physicians must never knowingly compromise the care of their patients, even for the sake of future patients. Equipoise has proven to be deeply problematic, especially in the Third World. Some recent critics have argued against equipoise on the grounds that clinical research is fundamentally distinct from clinical care, and thus should be governed by different norms. I argue against this “difference position,” and instead take issue with the traditional, exclusively patient-centered account of physicians' obligations that equipoise presupposes. In place of this traditional view, I propose a Kantian test for the reasonable partiality that physicians should show their patients, focusing on its application in clinical research and medical education.     

Uncertainty and the Ethics of Clinical Trials

A probabilistic explication is offered of equipoise and uncertainty in clinical trials. In order to be useful in the justification of clinical trials, equipoise has to be interpreted in terms of overlapping probability distributions of possible treatment outcomes, rather than point estimates representing expectation values. Uncertainty about treatment outcomes is shown to be a necessary but insufficient condition for the ethical defensibility of clinical trials. Additional requirements are proposed for the nature of that uncertainty. The indecisiveness of our criteria for cautious decision-making under uncertainty creates the leeway that makes clinical trials defensible.     

临床均势原则辨析——对临床科研方法的伦理思考

随机对照试验作为一种评价新疗法的可靠设计方法,开始逐渐被世界范围内的临床医生所广泛接受和采用,成为目前最重要的试验方法之一。RCT的运用应该遵循一定的伦理准则,即临床均势原则。围绕临床均势原则这一主题,对随机对照试验的方法论进行较为深入的伦理学思考。并对临床均势的内涵、伦理意义,以及这一伦理要求在实践中所引发的各种伦理争论加以探讨。     

Both Sides of the Coin: Randomization from the Perspectives of Physician-Investigators and Patient-Subjects

Randomization is the “gold standard” design for clinical research trials and is accepted as the best way to reduce bias. Although some controversy remains over this matter, we believe equipoise is the fundamental ethical requirement for conducting a randomized clinical trial. Despite much attention to the ethics of randomization, the moral psychology of this study design has not been explored. This article analyzes the ethical tensions that arise from conducting these studies and examines the moral psychology of this design from the perspectives of physician-investigators and patient-subjects. We conclude with a discussion of the practical implications of this analysis.