Emergency Medicine and the Development of the Food and Drug Administration's Final Rule on Informed Consent and Waiver of Informed Consent in Emergency Research Circumstances
Biros, Michelle H.
Runge, Jeffrey W.
Lewis, Roger J.
Academic Emergency Medicine. 1998 Apr; 5(4): 359-368.
This article reviews the federal regulations for emergency and acute resuscitation research in effect prior to October 1996, the historical issues that contributed to the development of these regulations, the controversies that arose surrounding the application of these regulations to emergency research circumstances, and the methods by which the regulations were changed. The new regulations introduced by the U.S. Food and Drug Administration (FDA) also are reviewed.
Critically Ill; Consent; Disclosure; Drugs; Emergency Care; Ethics; Ethics Committees; Federal Government; Food; Government; Government Regulation; Guidelines; Health; Human Experimentation; Informed Consent; Investigational Drugs; Investigators; Medical Devices; Medicine; Methods; Organizations; Patients; Professional Organizations; Public Participation; Regulation; Research; Research Ethics; Research Ethics Committees; Research Subjects; Resuscitation; Risks and Benefits; Therapeutic Research; Third Party Consent;
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Emergency Medicine and the Development of the Food and Drug Administration's Final Rule on Informed Consent and Waiver of Informed Consent in Emergency Research Circumstances Biros, Michelle H.; Runge, Jeffrey W.; Lewis, Roger J.; Doherty, Christopher (1998-04)