Miller B L
International Resuscitation Research Center, University of Pittsburgh, PA 15260.
Crit Care Med. 1988 Oct;16(10):1059-62. doi: 10.1097/00003246-198810000-00020.
Informed prospective consent for clinical resuscitation research may not be possible. Deferred consent is an untenable notion. Consent to continue in research cannot be used to support a claim that there was, or would have been, consent to the initiation of research. The conditions for the justifiability of resuscitation research without informed consent are: a) patient is comatose; b) lifesaving treatment must be given immediately; c) given all available evidence, there is reason to believe that the probability of death or severe deficit with experimental or control therapy is not greater than the probability of death or severe deficit on usual therapy; d) given all available evidence, there is reason to believe that the probability of normal or near-normal outcome is greater on experimental or control therapy than on usual therapy; and e) the study can provide evidence on whether there is a significant difference between experimental and control therapies in the incidence of normal or near-normal survival.
对于临床复苏研究，可能无法获得知情的前瞻性同意。延迟同意是一个站不住脚的概念。继续参与研究的同意不能用来支持这样一种说法，即存在或本会存在对研究启动的同意。在没有知情同意的情况下进行复苏研究的正当理由条件如下：a）患者昏迷；b）必须立即给予挽救生命的治疗；c）根据所有现有证据，有理由相信实验性或对照性治疗导致死亡或严重功能缺陷的概率不高于常规治疗导致死亡或严重功能缺陷的概率；d）根据所有现有证据，有理由相信实验性或对照性治疗比常规治疗产生正常或接近正常结果的概率更高；以及e）该研究能够提供证据，证明实验性治疗和对照性治疗在正常或接近正常生存发生率方面是否存在显著差异。
