• Acad Emerg Med · Apr 1998

    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.

    • M H Biros, J W Runge, R J Lewis, and C Doherty.
    • Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN 55415, USA. michelle.biros@co.hennepin.mn.us
    • Acad Emerg Med. 1998 Apr 1;5(4):359-68.

    AbstractThis 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.

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