摘要
目的分析目前我国临床研究跟踪审查的现状,结合《涉及人的生命科学和医学研究伦理审查办法》(以下简称"《办法》")对跟踪审查的要求,提出加强跟踪审查的对策,为规范研究机构伦理跟踪审查提供参考。方法通过文献研究方法,系统梳理跟踪审查现状,结合伦理审查工作实践体会,分析我国临床研究跟踪审查过程中可能存在的问题与相关原因。结果《办法》对跟踪审查的要求,包括强调落实跟踪审查、受委托的伦理委员会应负责跟踪审查、明确负责对合作研究的跟踪审查、明确参与研究机构的跟踪审查责任、增加伦理委员会督促提交跟踪审查的职责等。加强跟踪审查的对策包括卫生健康主管部门督促研究机构加强跟踪审查,研究机构加大力度落实跟踪审查,建立标准化的跟踪审查流程,强化研究者等相关人员的伦理培训,建立伦理委员会与研究者的多渠道沟通咨询方式,加强伦理委员会委员的审查能力,配备相应数量的伦理委员会工作人员,使用信息化手段提质增效。结论跟踪审查在整个研究开展过程中不可或缺,各方应采取措施确保跟踪审查的质量和效率,规范跟踪审查,促进生命科学和医学研究健康发展。
Objective This paper analyzed the current situation of clinical research continuing review in China,and puts forward countermeasures to strengthen continuing review in combination with the requirements of the Measures for the Ethical Review of Life Science and Medical Research Involving Humans,so as to provide a certain reference for standardizing the ethical continuing review of research institutions.Methods Through literature research,this paper systematically sorted out the current situation of continuing review,and analyzed many problems and related reasons in the process of continuing review of clinical research in China based on the practical experience of ethical review.Results The requirements for continuing review in the Measures for Ethical Review of Life Science and Medical Research Involving Humans included demphasizing the implementation of continuing review,the entrusted ethics committee should be responsible for continuing review,clarifying the responsibility for continuing review of cooperative research,clarifying the responsibility of participating research institutions for continuing review,and increasing the responsibility of the ethics committee to supervise the submission of continuing review.Countermeasures to strengthen continuing review included the health authorities urging research institutions to strengthen continuing review,research institutions to increase efforts to implement continuing review,establishing a standardized continuing review process,strengthening the ethics training of researchers and other relevant personnel,establishing a multi-channel communication and consultation method between the ethics committee and researchers,strengthening the review capacity of ethics committee members,allocating a corresponding number of ethics committee staff,and using information technology to improve quality and efficiency.Conclusions Continuing review is indispensable in the whole process of research development,and all parties should take measures to ensure the quality and efficiency of continuing review,standardize continuing review,and promote the healthy development of life science and medical research.
作者
章培
汪闻夕
裘晓蕙
陈军
周吉银
Zhang Pei;Wang Wenxi;Qiu Xiaohui;Chen Jun;Zhou Jiyin(Ethics committee office,Ningbo Medical Center Lihuili Hospital,Ningbo 315000,Zhejiang Province,China;Ethics committee,Ningbo Medical Center Lihuili Hospital,Ningbo 315000,Zhejiang Province,China;Scientific Research Department,Ningbo Medical Center Lihuili Hospital,Ningbo 315000,Zhejiang Province,China;Clinical Research Center,the Second Affiliated Hospital of Army Medical University,Chongqing 400037,China)
出处
《中华医学科研管理杂志》
2024年第3期192-197,共6页
Chinese Journal of Medical Science Research Management
基金
陆军军医大学人文社会科学基金重点项目(2022XRW02)。
关键词
涉及人的生命科学和医学研究
伦理委员会
跟踪审查
要求
对策
Life Science and Medicine Research involving Human
Ethics Committee
Continuing Review
Requirement
Strategy
作者简介
通信作者:周吉银,Email:zhoujiyin@outlook.com,电话:023-68763468。
