Human subjects protections in biomedical enhancement research: Assessing risk and benefit and obtaining informed consent

Abstract

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. © 2008 American Society of Law, Medicine & Ethics, Inc.