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.

Publisher: Wiley Country of Publication: United States NLM ID: 9418450 Publication Model: Print Cited Medium: Print ISSN: 1069-6563 (Print) Linking ISSN: 10696563 NLM ISO Abbreviation: Acad Emerg Med Subsets: MEDLINE

Publication: Hoboken, N.J. : Wiley
Original Publication: Philadelphia, PA : Hanley & Belfus, c1993-

Ethics, Medical* ; Federal Government* ; Government Regulation* ; Informed Consent*/legislation & jurisprudence ; Therapeutic Human Experimentation*; Emergency Medical Services/*standards ; Research/*standards; Disclosure ; Emergency Medical Services/legislation & jurisprudence ; Ethics Committees, Research ; Guidelines as Topic ; Humans ; Research/legislation & jurisprudence ; Research Subjects ; Risk Assessment ; United States ; United States Food and Drug Administration

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.

Indexing Agency: KIE Local ID #: 62801. Indexing Agency: NRCBL Local ID #: 18.3.
Keywords: Biomedical and Behavioral Research; Legal Approach; Office for Protection from Research Risks; U.S. Congress
Note: KIE BoB Subject Heading: human experimentation/informed consent Note: KIE BoB Subject Heading: human experimentation/regulation Note: Full author name: Biros, Michelle H Note: Full author name: Runge, Jeffrey W Note: Full author name: Lewis, Roger J Note: Full author name: Doherty, Christopher

Date Created: 19980430 Date Completed: 19980605 Latest Revision: 20190909

20240829

10.1111/j.1553-2712.1998.tb02722.x

9562204