摘要
2022年3月国家药品监督管理局发布了新版《医疗器械临床试验质量管理规范》,删除了伦理委员会组成和运行上的具体要求,简化了临床试验中递交初始审查文件、报告严重不良事件等流程。首先,梳理和分析了对伦理委员会的新要求,包括职责、组成、委员和秘书的资格和培训,以及档案的管理。其次,阐述对伦理初始审查的新要求,包括递交资料,审查内容,审查方式,审查结论,以及药械组合医疗器械和医疗器械使用学习曲线的风险管理,强调知情同意的合规性和有效性,严格限制免除知情同意的条件,并重新限定查阅试验资料的组织和个人。最后,阐述对跟踪审查的严重不良事件,器械缺陷,结题后临床试验资料的补正的新要求。新版《医疗器械临床试验质量管理规范》操作性更强,对伦理委员会的审查质量和效率提出了更高要求,伦理委员会应当在确保审查质量的前提下提高审查效率,以切实保障受试者的安全和权益。
The National Medical Products Administration issued a new version of the“Good Clinical Practice for Medical Devices(GCP)”in March 2022,which deleted specific requirements for the constitution and operation of the ethics committee and simplified the processes of submitting initial review documents and reporting serious adverse events in clinical trials.Firstly,the new requirements for ethics committees were sorted out and analyzed,including responsibilities,compositions,qualifications and training of members and secretaries,as well as the management of archives.Secondly,it elaborated on the new requirements for ethical initial reviews,including submission of materials,contents,methods,and conclusions of the review,as well as the learning curve risk management of drug-device combination medical devices and medical devices during use.It emphasized the compliance and validity of informed consent,strictly limited the conditions for exemption from informed consent,and redefined the organizations and individuals allowed to access trial data.Finally,it elaborated on the new requirements for follow-up review of serious adverse events,device defects,and new requirements for the correction clinical trial data after project the completion.The new version of the GCP is more operational and puts forward higher requirements for the review quality and efficiency of the ethics committee.The ethics committee should improve the review efficiency on the premise of ensuring the quality of the review,to effectively protect the safety,rights and interests of the subjects.
作者
杨千粟
白楠
周吉银
YANG Qiansu;BAI Nan;ZHOU Jiyin(Medical Supplies Center,Chinese People’sLiberation Army General Hospital,Beijing 100853,China;Clinical Research Center,the Second Affiliated Hospital of Army Medical University,Chongqing 400037,China)
出处
《中国医学伦理学》
北大核心
2024年第8期919-925,共7页
Chinese Medical Ethics
基金
2022年陆军军医大学人文社会科学基金重点项目“我市涉及人的健康相关研究伦理治理的现状与对策研究”(2022XRW02)。
