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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
Author(s) -
Biros Michelle H.,
Runge Jeffrey W.,
Lewis Roger J.,
Doherty Christopher
Publication year - 1998
Publication title -
academic emergency medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.221
H-Index - 124
eISSN - 1553-2712
pISSN - 1069-6563
DOI - 10.1111/j.1553-2712.1998.tb02722.x
Subject(s) - waiver , medicine , food and drug administration , informed consent , administration (probate law) , resuscitation , medical emergency , emergency department , cardiopulmonary resuscitation , clinical research , law , alternative medicine , emergency medicine , psychiatry , pathology , political science
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.