Conducting stroke research with an exception from the requirement for informed consent.
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.


RESULTS
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.
Bateman
Brian T
BT
College of Physicians and Surgeons, Columbia University, New York, NY 10032, USA.
Meyers
Philip M
PM
Schumacher
H Christian
HC
Mangla
Sundeep
S
Pile-Spellman
John
J
D026661:Clinical Trials Data Monitoring Committees / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic / Q000191:economics / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000379:methods / Q000592:standards; D003244:Consciousness Disorders / Q000209:etiology; D004630:Emergencies; D005380:Financing, Government / Q000331:legislation & jurisprudence; D006291:Health Policy; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards; D016743:Mental Competency; D017410:Practice Guidelines as Topic; D012109:Research Support as Topic / Q000331:legislation & jurisprudence; D012955:Societies, Medical; D013064:Speech Disorders / Q000209:etiology; D020521:Stroke / Q000150:complications / Q000523:psychology / Q000628:therapy*; D020458:Third-Party Consent / Q000331:legislation & jurisprudence; D014481:United States; D014483:United States Dept. of Health and Human Services / Q000331:legislation & jurisprudence; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence