CIOMS伦理准则的沿革对我国临床研究的影响

Implication of the Evolution of CIOMS Ethical Guidelines on Clinical Research in China

通过介绍CIOMS组织成立的历史以及该组织对于医学伦理所做出的贡献,回顾CIOMS伦理准则多个版本的修订,总结归纳出新版准则修订的突破点来自于扩大了准则的适用范围,从生物医学研究扩大到与健康相关的研究。同时还更加强调了研究的社会价值的重要性,强调在资源贫乏地区进行研究的公平性,以及对于社区参与、弱势群体和知情同意提出了新的建议。此外,对比国内临床试验伦理审查的现状,总结归纳出我国已经达到国际认识和操作标准的准则内容,指出尚未引起重视以及尚未细化的地方,尝试提出改进和建设性的意见。

This paper introduces the history of CIOMS and its contributions to medical ethics. By reviewing the revisions of several editions of CIOMS Ethics Guidelines, the authors analyze the backgrounds and reasons for the revisions. It concludes that the breakthrough point of the latest revision of CIOMS Ethics Guidelines comes from expanding the scope of application of CIOMS Guidelines, which is from biomedical research to health-related research. At the same time, it has a stronger emphasis on the revision of CIOMS Ethics Guidelines. The social value of research is emphasized, as well as the equity of research in low-resource settings. New suggestions on community participation, vulnerable groups and informed consent are put forward. Besides, by comparing with the current situation of ethical review of clinical trials in China, the authors summarize the contents of guidelines that have reached the international standards of understanding and operation, point out the areas that have not yet attracted attention and refined, and try to put forward constructive suggestions for improvement.