The Irrelevance of Equipoise

Abstract

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.

Keywords:

• consent to randomization
• equipoise
• idiosyncratic preferences
• individual versus clinical equipoise

Notes

1. Alternatively, one might say that sufficient evidence does exist to reject the null hypothesis at the 0.06 level, but we will not accept a conclusion as sufficiently demonstrated until one reaches some higher level of significance, say 0.05. The difference between rejecting a hypothesis at the 0.06 level and at the 0.05 level is marginal.

2. In fact, the Hippocratic Oath explicitly enjoins the clinician to make judgments to benefit the patient according to the physician's ability and judgment. The presentation of a widespread consensus to supporting some contrary conclusion is not required and is actually excluded if one assumes that the Hippocratic physician would determine that presenting the contrary account would confuse or upset the patient. We have, fortunately, outgrown the immoral paternalism of the Hippocratic Oath, but it is hard to imagine why the clinician would be prohibited from offering randomization just because he or she is out of equipoise.