摘要
高质量的伦理审查是确保伦理委员会履行其职责最重要的途径和策略,也是研究者、申办者、伦理委员会等利益相关各方的直接诉求。高质量的伦理审查不仅需要在保护受试者和促进研究规范开展之间取得较好的平衡,还应具备合规性、透明化、一致性和开放性等特征。以真实世界研究伦理审查的质量改进为例,结合真实世界研究伦理审查面临的核心问题、委员资质、知情同意等问题,阐释高质量伦理审查的特点与核心要义,并强调伦理审查的质量改进是一个持续的学习过程。
High-quality ethical review is the most important way and strategy to ensure the commitment of ethics committee.It is also the primary appeal of stakeholders,such as investigators,sponsors,and ethics committees.High-quality ethical reviews need to make a good balance between the protection of human subject and the promotion of health-related research.Meanwhile,several key characteristics include compliance,transparency,consistency,and openness of high-quality ethical review were proposed and discussed.By revealing challenges faced by real world study ethical review,such as the main challenges,committee member qualification,as well as informed consent,the quality improvement of real world study ethical review was taken as an example to illustrate its features and core principles.Finally,the paper urged that the quality improvement of ethical review is a continuous learning process.
作者
张海洪
熊保权
丛亚丽
ZHANG Hai-hong;XIONG Bao-quan;CONG Ya-li(The Research Department,Peking University Health Science Center,Beijing 100191,China)
出处
《医学与哲学》
北大核心
2021年第21期11-14,18,共5页
Medicine and Philosophy
基金
2020年北京市科委“北京市生命科学与生物医药伦理规范与监管支撑工作”课题(Jdc2020-011)。
