The Use of Placebo Controls

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Abstract
Rothman and Michels (Aug. 11 issue)1 object to the practice of giving “individual investigators and . . . institutional review boards the right to determine how much discomfort or temporary disability patients should endure for the purpose of research.” Regardless of what controls are used, precisely such a determination must be made concerning the foreseeable adverse effects of the treatment under study and the observation procedures. Is it really worse to ask an informed patient to volunteer to forgo treatment of mild hypertension for a few weeks than to ask a research subject to undergo a radiologic procedure or a series of phlebotomies that are not clinically necessary? Informed consent is admittedly an imperfect device for protecting subjects from unreasonable risk, but this problem applies equally to all aspects of medical research.

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