《赫尔辛基宣言》安慰剂使用原则的修订历程及启示

摘要

The provision about the use principle of placebo in Declaration of Helsinki in the year of 2000 caused great controversies,which focused on three aspects.Firstly,is there a need for placebo control? Secondly,can placebo control not violate ethical principles? Thirdly,what is the best standard of intervention? Around these controversies,the use principle of placebo in Declaration of Helsinki was revised for many times until the publication of Declaration of Helsinki in the year of 2013.To a certain extent,these revisions balanced the requirements of science and ethics,but still left problems with the practice of clinical trials and presented a great challenges to the ethics committee.Therefore,it is necessary to summarize the history and implications so as to strengthen the capacity building of ethics committee in clinical trial institutions and promote the quality of ethical review in China.%《赫尔辛基宣言》2000年版关于安慰剂使用条款的修订引起了很大争论,争议集中在三个方面:是否有必要使用安慰剂对照？使用安慰剂对照是否可以做到不违反伦理准则？什么是最佳干预标准？围绕这些争议,直到《赫尔辛基宣言》2013年版,其安慰剂使用条款经历了多次修订,在一定程度上平衡了科学性和伦理性的要求,但是仍然给临床试验的具体操作留下了问题,给伦理委员会提出了很大挑战.详细分析其历程,总结经验,旨在进一步加强我国临床试验机构伦理委员会能力建设,提升伦理审查质量.