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- Brian T Bateman, Philip M Meyers, H Christian Schumacher, Sundeep Mangla, and John Pile-Spellman.
- College of Physicians and Surgeons, Columbia University, New York, NY 10032, USA.
- Stroke. 2003 May 1; 34 (5): 1317-23.
BackgroundObtaining viable informed consent from stroke patients for participation in clinical trials of acute stroke therapies is often problematic because of patients' neurological deficits. Furthermore, obtaining permission from surrogates is often not possible or not legally permissible.Summary Of ReviewIn 1996 the Food and Drug Administration and Department of Health and Human Services published regulations that allow investigators to conduct emergency research without patient consent under a narrowly defined set of circumstances. We review requirements of these regulations, paying particular attention to how they may be applied in a clinical trial of an acute stroke therapy.ConclusionsAcute stroke researchers should consider conducting clinical trials with an exception from the informed consent requirement permitted by this law.
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