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(Stroke. 2003;34:1317.)
© 2003 American Heart Association, Inc.

Comments, Opinions, and Reviews

Conducting Stroke Research With an Exception From the Requirement for Informed Consent

Brian T. Bateman, BA; Philip M. Meyers, MD; H. Christian Schumacher, MD; Sundeep Mangla, MD John Pile-Spellman, MD

From the College of Physicians and Surgeons, Columbia University (B.T.B.); Departments of Radiology (P.M.M., S.M., J.P-S.) and Neurological Surgery (P.M.M., J.P-S.), University Hospitals of Columbia and Cornell; and Doris and Stanley Tananbaum Stroke Center (H.S.C.), Neurological Institute, Columbia-Presbyterian Medical Center, New York, NY.

Correspondence to Dr Philip Meyers, 177 Fort Washington Ave, Milstein Hospital Building 8 South, Columbia University, New York, NY 10032. E-mail pmm2002{at}columbia.edu

Background— Obtaining 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 Review— In 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.

Conclusions— Acute stroke researchers should consider conducting clinical trials with an exception from the informed consent requirement permitted by this law.

Key Words: ethics, medical • informed consent • stroke

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