Informed consent: protection or obstacle? Some emerging issues.
There is widespread consensus on the need for informed consent procedures in medical research. Nevertheless, aspects of the informed consent process remain controversial, and innovative approaches to research may raise new issues and concerns. The randomized consent design for clinical trials, proposed by Zelen (N Engl J Med 1979; 300:1242-1245), permitted physicians to randomize patients without consent, then obtain informed consent from only those patients randomized to the experimental (as opposed to the standard treatment) arm. More recently, the proposal has been made to allow waiver of informed consent for study of patients in emergency circumstances who may be temporarily incapable of providing such consent, and for whom no family member is immediately available to give a "proxy" consent (Biros M.H. et al. JAMA 1995; 273:1283-1287). The medical community and federal regulatory policy have responded differently to these proposals.
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Division of Biostatistics and Epidemiology, Food and Drug Administration, Rockville, Maryland, USA.
D004638:Emergency Treatment; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D016032:Randomized Controlled Trials as Topic / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration