Equipoise May Be in the Eye of the Beholder

摘要

We commend Dr. Wendler (2009) for initiating this discussion of what aspects of randomization may and may not be necessary for trial participants to understand in order to provide valid consent. Wendler’s article prompts researchers not to simply ignore important evidence that outcomes of informed consent procedures are flawed, particularly with regard to participants’ understanding of randomization. Furthermore, rather than reflexively recommending that informed consent procedures become more complicated and onerous in an effort to ensure such understanding,Wendler asks to what extent it matters ethically whether participants understand: 1) how a randomized schedule of allocation is arrived at, and 2) that the type of treatment that participants receive will be dictated by chance rather than a clinician’s recommendation.