Equipoise and the criteria for reasonable action.

441 In her recent article, “Evidence, Belief, and Action: The Failure of Equipoise to Resolve the Ethical Tension in the Randomized Clinical Trial,” Deborah Hellman gives a new twist to an old objection against clinical equipoise.1 Roughly, clinical equipoise is the requirement that there exist credible uncertainty in the expert medical community regarding the preferred treatment for a particular condition. This uncertainty is widely regarded as a necessary condition for enrolling participants in a clinical trial. The old objection is that clinical equipoise represents an overly permissive, and therefore morally unacceptable, mechanism for resolving the fundamental tension in clinical research between fidelity to the interests of the individual research participant, and fidelity to the statistical and scientific methods that are necessary to produce generalizable data in a reliable manner.2 Hellman’s new twist on this objection utilizes some of the rudimentary architecture of Bayesian statistical theory to argue that clinical equipoise focuses our moral attention on the wrong issue. In particular, she claims that clinical equipoise permits an individual to be randomly assigned to a particular intervention when there is uncertainty within the larger medical community about the relative therapeutic merits of that intervention in comparison with the available alternatives. Hellman’s central thesis is that uncertainty of this type lies in the belief of clinicians about the relative therapeutic merits of a set of interventions in the abstract, and that this does not address the central moral question: namely, whether allowing a patient to be randomized to these particular alternatives is consistent with a basic regard for the patient’s health interests. Because uncertainty about the relative therapeutic merits of a set of interventions in the abstract might coexist with a determinate treatment preference for an individual with a specific medical profile, Hellman argues that the requirement that a trial begin in and be designed to disturb a state of equipoise is incapable of protecting the interests of individual trial participants. As a result, she holds that the equipoise requirement should be rejected as an inappropriate moral standard for regulating clinical research. In the discussion that follows, we argue that Hellman’s arguments do not take their own lessons far enough. Not only should equipoise be understood as a decision rule for determining when participation in a clinical trial is an admissible option for each individual trial participant, but equipoise should also be understood as playing an important role in establishing the proper relationship between clinical research and medical practice, and providing a normative standard for initiating and terminating clinical trials. The merits of adopting such a conception of equipoise are easily illustrated using the rudimentary statistical and methodological ideas that Hellman herself relies on in her critique. As a result, our response to Hellman is significant not only as a rebuttal of the most recent forEquipoise and the Criteria for Reasonable Action