Stroke · 2003
Conducting stroke research with an exception from the requirement for informed consent.
СтатьяПоддержка исследования: вне правительства СШАОбзорНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Bateman Brian T, Meyers Philip M, Schumacher H Christian, Mangla Sundeep, Pile-Spellman John
Аннотация
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.
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.
Предметные рубрики MeSH
Clinical Trials Data Monitoring CommitteesClinical Trials as TopicConsciousness DisordersEmergenciesFinancing, GovernmentHealth PolicyHumansInformed ConsentMental CompetencyPractice Guidelines as TopicResearch Support as TopicSocieties, MedicalSpeech DisordersStrokeThird-Party ConsentUnited StatesUnited States Dept. of Health and Human ServicesUnited States Food and Drug Administration