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August 27, 1997

Bioethics Commission Examines Informed Consent From Subjects Who Are 'Decisionally Incapable'

JAMA. 1997;278(8):618-619. doi:10.1001/jama.1997.03550080024012

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THE NATIONAL Bioethics Advisory Commission has turned its attention from an administration-mandated consideration of cloning to one of the major issues it was created to examine—the further steps needed to better protect human subjects who participate in medical research.

The commission is addressing the issue of obtaining informed consent from "decisionally incapable" subjects, in the phrase used by the chair of its human subjects subcommittee, James F. Childress, PhD, Kyle Professor of Religious Studies at the University of Virginia, Charlottesville.

While federal regulations have been in force for a number of years to ensure that properly informed consent is obtained from human research subjects or their legally authorized surrogates, these regulations do not address the competence of research subjects to decide to participate in studies. Some research, especially in the area of neurobiology, involves subjects who may be cognitively impaired to some degree.

At the subcommittee's meeting in July, the