关于医学伦理审查互认联盟的认知与思考

Cognition and Thinking about the Alliance of Mutual Recognition of Medical Ethics Review

成立于2020年12月1日的北京市医学伦理审查互认联盟,可使成员单位遵循统一的工作规则、审查内容、审查标准、文本格式、审查频次和审批时间对多中心临床研究伦理审查互认,以避免重复审查、提高效率、保证伦理审查质量,更好地保护受试者,并可引领北京地区医疗机构伦理审查水平的整体提高。需探讨的是:第一,提高效率并非放弃质量、减少审查内容,无质量的效率是无用功,时效性则需各方面努力;第二,目前来看政府部门作为监督者对联盟进行指导建设是较佳选择,选择秘书单位作为依托单位且实行轮换制度是较优方案;第三,需要探讨联盟初审后的运行审查监管机制,特别是跟踪审查;第四,需要探讨论证相关理论,探讨建立完善的法规体系与连贯的制度体系,以获得法律、政策、条例等方面的支持,进而制定具体指南,保障伦理审查的权威性、可靠性、公信力;第五,可探讨联合审查、专家共享,尤其是对一些重大课题、高风险项目。

Beijing Alliance for Mutual Recognition of Medical Ethics Review was established on December 1,2020,allows members to follow the unified rules of the work,examination content,examination standard,text format,review the frequency and time of examination and approval of multi-center clinical research ethics review mutual recognition,in order to avoid repeated examination,improve efficiency,ensure the quality of ethical review,better protection for the participants,and may lead to Beijing the overall improvement of ethical review level in regional medical institutions.It is necessary to discuss the following aspects:First,improving efficiency does not mean giving up quality,reducing review content.Efficiency without quality is useless,while timeliness requires efforts from all aspects;Second,at present,it is better for government departments to guide the construction of the alliance as supervisors,and it is better to choose the secretary unit as the supporting unit and implement the rotation system;Third,it is necessary to discuss the operational review supervision mechanism after the initial review of the alliance,especially the follow-up review;Fourth,it is necessary to discuss and demonstrate relevant theories,explore the establishment of a sound legal system and a coherent institutional system,in order to obtain the support of laws,policies and regulations,and then formulate specific guidelines to e nsure the authority,reliability and credibility of ethical review;Fifth,it is necessary to discuss joint review and expert sharing,especially for some major topics and high-risk projects.