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September 25, 1996

Ethics of Proxy Consent for Research Involving Patients With Adult Respiratory Distress Syndrome

Author Affiliations

National Institutes of Health Bethesda, Md

JAMA. 1996;276(12):949. doi:10.1001/jama.1996.03540120027015

To the Editor.  —Regarding the article by Dr Hirschl and colleagues1 and the accompanying Editorial by Dr Petty,2 the study by Hirschl et al was conducted in a surgical intensive care unit and "[i]nformed consent was obtained from the families of all participants."1I think the authors and JAMA missed an opportunity to inform others about some important ethical issues, including informed consent, related to the conduct of research in emergency circumstances.Over the last few years in the United States, one of the most debated issues in clinical research has been the protection of human research subjects in emergency circumstances.3 Much attention has been given to the ethical permissibility of waiver of informed consent, surrogate consent by family members or other representatives, and "deferred" consent, which has been disallowed by both the Food and Drug Administration (FDA) and the US Department of Health and Human