Biros M H, Runge J W, Lewis R J, Doherty C
Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN 55415, USA.
Acad Emerg Med. 1998 Apr;5(4):359-68. doi: 10.1111/j.1553-2712.1998.tb02722.x.
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.
本文回顾了1996年10月之前生效的联邦紧急情况和急性复苏研究法规、促成这些法规制定的历史问题、围绕这些法规在紧急研究情况下的应用所产生的争议，以及法规变更的方式。还对美国食品药品监督管理局（FDA）出台的新法规进行了回顾。
