安慰剂对照临床研究的伦理学要求

在临床研究中，安慰剂对照一直以来是个争论不休的伦理问题。如何保证临床研究的科学性，而又不违背伦理，伦理委员会在其中起着非常重要的作用。介绍了中国中医科学院广安门医院医学伦理委员会在审议安慰剂对照的临床研究中所审议的要点，即坚持受试者的获利大于风险；审议受试者的受益／风险；研究方案中的退出标准、补偿措施、不良事件的处理措施；知情同意书中的充分告知以及最终决议的方式。

The ethical requirement of the placebo-controlled clinical study

Placebo-controlled clinical study is the ethical issue being debated all over the time.The ethics committee plays an important role in the assurance of the scientificalness of clinical research without violation of ethics.This article introduces the main points considered in the placebo-controlled clinical study in Medical Ethics Committee of Guang'anmen Hospital of China Academy of Traditional Chinese Medicine.These points are as follows,the benefit of the subject greater than the risk,considerations on the benefit / risk of the subjects,the disposal of compensation measures and adverse events in research program and fully informed consent as well as the model of final resolution.