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December 18, 1981

Informed Consent in Resuscitation Research

Author Affiliations

From the Department of Anesthesiology/Critical Care Medicine, Resuscitation Research Center, Pittsburgh (Drs Abramson and Safar), Law and Psychiatry Program of the Western Psychiatric Institute and Clinic, University Health Center of Pittsburgh (Mr Meisel), and the School of Law, University of Pittsburgh (Mr Meisel).

JAMA. 1981;246(24):2828-2830. doi:10.1001/jama.1981.03320240036021

SCIENTIFICALLY proved advances in care of the critically ill patient are expected, accepted, and perhaps even demanded by society. This is illustrated by the tremendous growth in federal funding for National Institutes of Health (NIH)-sponsored biomedical research between 1945 and 1965.1 However, the resulting medical advances have produced unanticipated ethical and legal problems. In this article, we address the emerging conflict between two restraints on clinical research: (1) the assurance of scientifically valid results and (2) the protection of the human rights of research subjects. This conflict is particularly acute in resuscitation research, where immediate medical intervention is necessary and the potential research subjects are comatose.

THE CONFLICT  At present all biomedical and behavioral research supported by federal funds must conform to legal requirements promulgated by the Department of Health and Human Services (DHHS).2 (New DHHS regulations were issued July 27, 1981.3 They are complemented by new