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Previous Volume 348:1389-1392 April 3, 2003 Number 14 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

	Full Text PDF PDA Full Text Purchase this article Editorial by Drazen, J. M. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

Although the federal government funds research to improve the lives of critically ill adults and of the people who care for them, recent investigations show that it does not provide investigators with guidelines for ensuring that such research is on firm ethical grounds, especially in the case of cognitively impaired subjects.^1,2,3,4 Federal regulations for the protection of research participants, known as "the common rule," require that research involving "vulnerable" subjects include "additional safeguards" (45 CFR 46.111) and that the investigator obtain informed consent from a "legally authorized representative" (45 CFR 46.116).⁵ But the rule does not describe safeguards in detail, . . . [Full Text of this Article]

Assent, Dissent, and Advance Informed Consent

Proxy Decision Making

Reasonable Research Risks

Conclusions

Source Information

From the Department of Medicine, Division of Geriatric Medicine, the Institute on Aging, the Leonard Davis Institute of Health Economics, the Center for Bioethics, the Center for Clinical Epidemiology and Biostatistics, and the Alzheimer's Disease Center, University of Pennsylvania, Philadelphia.

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N Engl J Med 2003; 349:188-192, Jul 10, 2003. Correspondence

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