某传染病医院提高伦理审查效率的实践路径与管理策略  

Practice path and management strategy on accelerating ethical review efficiency in one infectious disease hospital

作　　者：周运翱[1] 万钢[1] 杨志云[1] 贾王彦 ZHOU Yun-ao;WAN Gang;YANG Zhi-yun;JIA Wang-yan(Beijing Ditan Hospital,Capital Medical University,Beijing 100015,China)

机构地区：[1]首都医科大学附属北京地坛医院,北京100015

出　　处：《中国新药杂志》2022年第11期1085-1090,共6页Chinese Journal of New Drugs

基　　金：北京市医院管理中心培育计划项目(PG2020033);北京医学伦理学会科研项目(BMEA2021102)。

摘　　要：目的:提高多中心临床研究的伦理审查质量与效率,既是促进国家医药卫生事业创新发展、加快新药创制与临床研究成果转化的重要保障,也是切实保护受试者权益的重要举措,符合申办者、研究者、研究机构各方的利益需求。方法:对北京地坛医院2019年1月—2021年12月近3年伦理委员会受理审查的项目信息、立项送审时效、伦理审查时效指标进行回顾性研究,分析影响伦理审查效率的因素。结果:采用伦理互认审查方式的效率(4.30 d·项^(-1))明显优于传统审查方式的效率(8.07 d·项^(-1)),医院临床试验项目管理系统(CTMS)能够有效压缩送审时间(上线使用前1 d、上线使用后0 d)和审查时间(上线使用前7 d、上线使用后3 d)。结论:伦理互认、统一的项目立项标准、增加开会频次、完善的制度体系与共识规则、信息化建设、人力投入与人才培养等都是提高伦理审查效率与质量的有效途径。Objective:Improving the quality and efficiency of ethical review in multi-center clinical research is not only an important guarantee to promote the innovative development of national medical and health undertakings,accelerate the creation of new drugs and the transformation of clinical research results,but also a significant measure to effectively protect the rights and interests of the subjects.This is in line with the interests of sponsors,researchers and research institutions.Methods:In this study,to analyze the factors affecting the efficiency of ethical review,a retrospective study was conducted on the project information accepted and reviewed by the ethics committee of Beijing Ditan Hospital from January 2019 to December 2021,as well as on the prescription of project submission and prescription index of ethical review.Results:The results show that the efficiency of mutual recognition review(4.30 d·item^(-1))was significantly faster than that of traditional review(8.07 d·item^(-1)).The CTMS can effectively compress the submission time(1 days before using it,0 days after using it)and the review time(7 days before using it,3 days after using it).Conclusion:Mutual recognition of ethics,unified project standards,increasing the frequency of meetings,perfect system and consensus rules,information construction,human input and talent training are all effective ways to improve the efficiency and quality of ethical review.

关 键 词：传染病 临床研究 审查效率 路径策略 

分 类 号：R95[医药卫生—药学]