EMERGENCY-MEDICINE AND THE DEVELOPMENT OF THE FOOD-AND-DRUG-ADMINISTRATION FINAL RULE ON INFORMED CONSENT AND WAIVER OF INFORMED CONSENT INEMERGENCY RESEARCH CIRCUMSTANCES

This article reviews the federal regulations for emergency and acute r esuscitation research in effect prior to October 1996, the historical issues that contributed to the development of these regulations, the c ontroversies that arose surrounding the application of these regulatio ns to emergency research circumstances, and the methods by which the r egulations were changed. The new regulations introduced by the U.S, Fo od and Drug Administration (FDA) also are reviewed.