Abramson N S, Meisel A, Safar P
JAMA. 1986 May 9;255(18):2466-71. doi: 10.1001/jama.255.18.2466.
Methodological constraints inherent in the rapidly growing field of resuscitation research have created an apparent conflict with newly promulgated federal regulations, especially those concerning informed consent requirements. We propose that two new concepts be applied to resuscitation research to satisfy the current federal regulations governing biomedical research. The first of these concepts is "minimal differential risk," ie, in resuscitation medicine, the difference between the risk of an undesirable outcome when standard, commonly accepted therapy may be used and the risk of an undesirable outcome with experimental therapy is minimal. The second concept is "deferred consent," ie, obtaining consent to continue with an experimental therapy after administration of that therapy has already begun. We believe that the emergency exception to informed consent applies to resuscitation research. Recognition of the applicability of these concepts to resuscitation research should allow compliance with federal and state regulations that otherwise might inhibit or preclude such research endeavors.
复苏研究这一快速发展领域中固有的方法学限制，已与新颁布的联邦法规产生了明显冲突，尤其是那些关于知情同意要求的法规。我们建议将两个新概念应用于复苏研究，以符合当前管理生物医学研究的联邦法规。其中第一个概念是“最小差异风险”，即在复苏医学中，使用标准的、普遍接受的治疗方法时出现不良后果的风险与使用实验性治疗方法时出现不良后果的风险之间的差异极小。第二个概念是“延迟同意”，即在已经开始实施实验性治疗后再获取继续该治疗的同意。我们认为知情同意的紧急例外情况适用于复苏研究。认识到这些概念对复苏研究的适用性，应能确保符合联邦和州法规，否则这些法规可能会抑制或阻碍此类研究工作。
