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Human Subjects Protections in Biomedical Enhancement Research: Assessing Risk and Benefit and Obtaining Informed Consent

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The protection of human subjects in biomedical research relies on two principal mechanisms: assessing and comparing the risks and potential benefits of proposed research, and obtaining potential subjects' informed consent. While these have been discussed extensively in the literature, no attention has been paid to whether the processes should be different when the objective of an experimental biomedical intervention is to improve individual appearance, performance, or capability (“enhancement research”) rather than to prevent, cure, or mitigate disease (“health-oriented research”). This essay examines this question in order to ensure that subjects in biomedical enhancement research receive adequate protection.
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Document Type: Research Article

Affiliations: 1: Arthur E. Petersilge Professor of Law and the Director of The Law-Medicine Center at Case Western Reserve University School of Law, and a Professor of Bioethics at Case Western Reserve University School of Medicine. 2: Professor of Law and Bioethics at Case Western Reserve University Schools of Law and Medicine.

Publication date: 2008-09-01

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