伦理委员会办公室在提高伦理审查质量中的作用  

The Role of Ethics Committee Office in Improving the Quality of Ethical Review

作　　者：盛艾娟[1] 王小琪[1] 陈晓云[2] 孟莎[1] 王美霞[1] 贾敏[1] 孙桂珍[1] SHENG Aijuan;WANG Xiaoqi;CHEN Xiaoyun;MENG Sha;WANG Meixia;JIA Min;SUN Guizhen(Beijing You’an Hospital Affiliated to Capital Medical University,Beijing 100069,China;Department of Medical Ethics Office,Longhua Hospital Shanghai University of Traditional Medicine,Shanghai 200032,China)

机构地区：[1]首都医科大学附属北京佑安医院,北京100069 [2]上海中医药大学附属龙华医院医学伦理办公室,上海200032

出　　处：《中国医学伦理学》2021年第3期337-341,共5页Chinese Medical Ethics

基　　金：陕西省健康文化研究中心项目“基于感染及传染性疾病临床研究的伦理委员审查能力评估和准入机制探讨”(JKWH2019-Q01)。

摘　　要：不断发展的科学技术和临床研究给伦理审查带来更多的挑战,对伦理审查提出了更高的要求,伦理委员会办公室在提高伦理审查质量中的作用也愈发凸显。结合多年的工作经验,从研读政策、积极应对,依法依规、规章建制,积极献策、健全体系,强化质控、提高质量,强化培训、提高能力,强化协调、部门联动六个方面阐述了伦理委员会办公室在提高伦理审查质量中的作用,助力提高伦理审查质量和效率。The continuous development of science and technology and clinical research have brought more challenges to ethical review,and put forward higher requirements for ethical review.The role of the office of ethics committee in improving the quality of ethical review has become increasingly important.Combined with many years of work experience,this paper expounded the role of the ethics committee office in improving the quality of ethical review,and helps to improve the quality and efficiency of ethical review from six aspects:studying policies and responding actively,building the system according to laws and regulations,extremely offering suggestions and improving the system,strengthening quality control and improving quality,strengthening training and improving ability,strengthening coordination and departmental linkage.

关 键 词：伦理审查 伦理委员会办公室 临床研究 伦理审查质量 

分 类 号：R-052[医药卫生]