北京市医疗机构多中心临床研究伦理审查互认的实践与思考

Practice and Thinking on the Mutual Recognition of Ethical Review of Multi-center Clinical Research in Medical Institutions in Beijing

伦理审查互认是多中心临床研究发展的必然趋势。在北京市卫生健康委员会的领导下,北京市医疗机构自愿组建北京市医学伦理审查互认联盟,制订《北京市医学伦理审查互认联盟工作规则》和《北京市医学伦理审查互认细则》。北京市医学伦理审查互认采用协作审查模式,互认范围从药械临床试验扩展到所有临床研究项目;同时也推出了统一的伦理审查申请相关文件清单等模板,以节约申办者和研究者准备资料的时间;创建了伦理互认信息平台,使伦理互认各方有了可依托的工作载体,互认信息公开透明,便于相互监督,利于政府监管。北京市医学伦理审查互认可为多中心临床研究伦理审查互认模式在全国的推广提供参考。

Mutual recognition of ethical review is an inevitable trend in the development of multi-center clinical research.Under the leadership of the Beijing Municipal Health Commission,Beijing medical institutions voluntarily established the Beijing Medical Ethics Review Mutual Recognition Alliance,and formulated the Working Rules of Beijing Medical Ethics Review Mutual Recognition Alliance and the Regulations of Beijing Medical Ethics Review Mutual Recognition.Beijing Municipal Medical Ethics Review Mutual Recognition adopted a collaborative review model,and the scope of mutual recognition has been extended from drugs and devices clinical trials to all clinical research projects.Meanwhile,a unified list of relevant documents for ethical review applications has also been introduced in order to save the time for sponsors and researchers to prepare materials.An information platform for ethical mutual recognition has been set up,so that all parties to ethical mutual recognition have a work carrier that can be supported.Mutual recognition information is open and transparent,which is convenient for mutual supervision and government supervision.The Beijing Municipal Medical Ethics Review Mutual Recognition provides a reference for the national promotion of the multi-center clinical research ethics review mutual recognition model.