Abramson N S, Safar P
International Resuscitation Research Center, Pittsburgh, Pennsylvania 15260.
Ann Emerg Med. 1990 Jul;19(7):781-4. doi: 10.1016/s0196-0644(05)81703-2.
Deferred consent, a new approach to the requirement for informed consent in clinical research, was used in a randomized clinical trial of brain resuscitation after cardiac arrest. Because patients were comatose and therapy had to be initiated immediately, traditional prospective consent usually could not be obtained. Using the deferred consent mechanism, family members were contacted after the first dose of experimental drug or placebo was administered and asked to consent for continued study participation. The vast majority of families were satisfied with the deferred consent mechanism. Their main concerns were about the safety of the experimental drug and whether the active drug or placebo was given. The concepts of randomization, blinding, and placebo-treated controls were generally not well understood. Although our experiences confirmed the impracticality of attempting to obtain traditional prospective consent in clinical resuscitation research, deferred consent was found to be a reasonable solution.
延迟同意是临床研究中知情同意要求的一种新方法，在一项心脏骤停后脑复苏的随机临床试验中得到应用。由于患者处于昏迷状态且必须立即开始治疗，通常无法获得传统的前瞻性同意。采用延迟同意机制，在给予第一剂实验药物或安慰剂后联系家庭成员，并要求他们同意继续参与研究。绝大多数家庭对延迟同意机制感到满意。他们主要关心的是实验药物的安全性以及给予的是活性药物还是安慰剂。随机化、盲法和安慰剂对照的概念通常没有得到很好的理解。尽管我们的经验证实了在临床复苏研究中试图获得传统前瞻性同意是不切实际的，但延迟同意被认为是一个合理的解决方案。
