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Commentary on Kim Miller

In this commentary, Kim and Miller aim to refute what they refer to as the Standard of Care Principle, which they define as the view that studies that randomize between common clinical practices do not ‘‘raise significant ethical issues.’’ They are critical of others whom they believe support this ‘‘principle,’’ even though this explicit ‘‘principle’’ has not been articulated by those they criticize. Their approach is problematic because it is not clear to what they are objecting, and their labeling the concern as ‘‘standard of care’’ only adds further confusion. We agree with two of the substantive comments in their article: (1) the social value and clinical validity of research on medical practices should be considered in the review process and (2) study participants should typically be aware of the purpose of a study and the alternatives to participation. But the tone of their article conveys a diffuse and vague criticism of others who probably do not hold the view appearing to be the subject of their critique. Furthermore, while there may be important substantive differences between the argument in this article and other proposals, including other articles written by Kim and Miller about the rationale for regulatory waivers or alternation of consent and documentation, this article does little to elucidate those distinctions. The focus on the Standard of Care Principle is distracting and does not advance the exploration of important related issues. First, the Standard of Care Principle has not been articulated previously in the literature and Kim and Miller do not define it clearly enough to make sense of it. We recommend that further discussions of this issue use greater specificity. It is difficult to know what it means to not ‘‘raise significant ethical issues.’’ Consider each of the following claims about the ethical approaches to randomization between common clinical practices: