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In Reply: Drs Clayton and Ross claim that our recommendations conflate the purposes of clinical care and research and, thus, promote the therapeutic misconception. We agree that it is important to consider research and therapy as separate and distinct activities.^1-2 However, our position does not conflate research and therapy. Such an effect is more likely a result of the current ethics guidelines, which limit disclosure to results judged by health care professionals to have clinical utility.

The heart of the controversy surrounding disclosure of individual research results concerns the most appropriate manner of expressing respect for participants: limiting disclosure to those results that have established clinical utility vs recognizing a presumption that results should be made available to participants on request.

Respect for persons underlies the basic principles of research ethics, including the requirements to minimize research-related risks and obtain informed consent. Although these requirements are important, focusing exclusively on . . . [Full Text of this Article]

David I. Shalowitz, AB; Franklin G. Miller, PhD
fmiller@nih.gov
Department of Clinical Bioethics
National Institutes of Health
Bethesda, Md

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