医疗新技术临床准入与应用的伦理审查实践及思考

Practice and reflection on ethical review of clinical access and application of new medical technology

目的针对目前国内医疗技术伦理审查的相关法律法规尚不完善的情况, 从规范化角度对医疗新技术临床准入与应用的伦理审查提供参考。方法参照临床科研伦理审查的相关法规和具体实施办法, 结合笔者所在医院机构伦理委员会的实践经验, 系统总结了临床应用性医疗新技术的概念特点、存在的问题, 优化了技术准入前伦理审查工作步骤, 建立了技术应用后伦理跟踪审查模式。结果通过制定准入流程、健全管理制度、优化伦理审查过程和审查方式, 并重视对医疗新技术应用进行年度跟踪审查、医疗不良事件报告审查、暂停/终止应用审查、总结审查、实地访查, 增加了伦理审查的主动性和时效性, 提高了伦理审查效率, 保证了伦理审查的连续性。结论在实践中规范医疗新技术临床准入与应用的伦理审查十分重要, 一方面能够有效补足相关法规尚不完善的短板, 推动新法出台, 另一方面能有效降低医疗技术风险, 构建良好的医疗质量管理与改进体系, 更好地维护人民群众健康权益。

Objective Taking into account of the current situation that domestic laws and regulations of medical technology ethics review are not perfect,we put forward practical suggestions on ethical review supervision of the clinical application of new medical technologies from the perspective of standardization.Methods Referring to the relevant laws,regulations and specific implementation guidelines of ethical review of clinical research,combined with the practical experience of the ethics committee of the host Hospital,this paper systematically summarizes the concept and characteristics and existing problems of new clinical applied medical technology,optimizes the working steps of technology access and ethical review,and establishes an ethical continuing review model.Results A series of measurements are proposed,which including formulate the access process,improve the management system,optimize ethical review methods,etc.At the same time,pay more attention to the annual continuing review,adverse event report review,suspension/termination of approved research,closure report review,as well as site visit to improve the initiative and efficiency of ethical review.At last,it ensures the continuing of ethical review.Conclusions It is very important to regulate new medical technology project entry and ethical review supervision in the practice.On one hand,it can effectively make up for the possible shortcomings of current laws and regulations and promote the introduction of new regulatory requirement.On the other hand,it can effectively reduce the medical technology risks and build good medical quality management,improve the system to better safeguard people′s health rights and interests.