摘要
全面介绍了英国当前医学研究伦理审查体系与现行法规,总结其特色在于:建立了全国自上而下的中央化审查管理模式,独立于研究者、资助方、申办方以及开展研究的机构;分布在不同区域的各类别伦理委员会采用全国统一的标准操作规程运行;通过电子信息化系统统一受理全国的伦理申请;伦理审查采用与项目特点相称的审查形式,并关注公众参与及受试者权益保护等。结合国内现状,提出建立更全面的伦理监管体系并探索多样化的伦理审查形式。另外,医疗机构内应加强临床研究全流程管理,确保伦理委员会聚焦并围绕受试者权益保护,进行充分、有效的伦理审查。
This paper introduces the current medical research ethics review system,guidance and regulations in the UK.It has centralized review management model,independent of researcher,funder and institute.The national Standard Operating Procedures for Research Ethics Committees has been followed in every region.Applications are submitted on the electronic application system.Review types base on the proportionate principles.Subjects protection and public involvement in review are advocated.The following suggestions are raised based on the domestic practice,including establishing a more comprehensive ethical supervision system,so as to ensure the role and responsibility of the ethics committee for subjects protection by improving the clinical research management in hospitals.
作者
吉萍
JI Ping(Clinical Research Institute,Shenzhen-Peking University-The Hong Kong University of Science&Technology Medical Center,Shenzhen 518036,China)
出处
《医学与哲学》
2020年第9期30-33,共4页
Medicine and Philosophy
基金
2016年深圳市医疗卫生“三名工程”项目(SZSM201612061)。
关键词
英国伦理监管
伦理审查
伦理管理
UK ethics regulation
ethics review
ethical management
