我国药物临床试验伦理审查能力的调查研究  

Investigation on Ethical Review Ability of Drug Clinical Trials in China

作　　者：谢洁琼[1] 余中光[2] 陆麒[3] 吴翠云[4] 陈虎[5] 黄瑾 李素娟[7] 刘海涛 熊宁宁[9] XIE Jieqiong;YU Zhongguang;LU Qi;WU Cuiyun;CHEN Hu;HUANG Jin;LI Sujuan;LIU Haita;XIONG Ningning(China Food and Drug Administration Institute of Executive Development, Beijing 100073;China-Japan Friendship Hospital, Beijing 100029, China;Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200127, China;Huashan Hospital Affiliated to Fudan University, Shanghai 200040, China;Cangzhou Central Hospital, Cangzhou 061001, China;Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China;Jinan Central Hospital, Jinan 250013, China;Jansen (China) Research & Development Center, Johnson & Johnson (China) Investment Ltd;Affiliated Hospital of Nanjing University of TCM, Nanjing 210029, China)

机构地区：[1]国家食品药品监督管理总局高级研修学院,北京100073 [2]中日友好医院,北京100029 [3]上海交通大学医学院附属仁济医院,上海201112 [4]复旦大学附属华山医院,上海200040 [5]沧州市中心医院,河北沧州061001 [6]上海中医药大学附属岳阳中西医结合医院,上海200437 [7]济南市中心医院,山东济南250013 [8]强生(中国)投资有限公司杨森(中国)研发中心,上海200233 [9]南京中医药大学附属医院,江苏南京210029

出　　处：《中国医学伦理学》2019年第2期213-216,共4页Chinese Medical Ethics

摘　　要：伦理审查能力是药物临床试验伦理委员会建设与管理的核心环节。伦理委员会的审查能力不仅是委员遵循公认的伦理原则对研究方案进行审议和决定的能力,还取决于与伦理委员会审查相关的程序规则。采用调查问卷的方式,采集我国354家药物临床试验机构伦理审查的程序、规则以及质量管理情况,包括审查工具、审查效率、主审、预审、独立顾问、审查、审查会议规则、年度/定期审查、复审管理、委员履职能力考核、质量管理等,分析伦理审查能力并对改进伦理审查能力提出相应的建议。The ability of ethical review is the key link in the construction and management of ethics committee for drug clinical trials. The review ability of ethics committees depends not only on the ability of members to consider and decide on research programs in accordance with generally accepted ethical principles, but also on the procedural rules related to the review of ethics committees. Questionnaires were used to collect the procedures, rules and quality management of ethical review in 354 drug clinical trial institutions in China, including review tools, review efficiency, chief auditor, pre-trial, independent consultant, review, review meeting rules, annual/periodic review, review management, assessment of performance ability of committee members and quality management, etc. To analyze the ability of ethical review and put forward some corresponding suggestions for improving the ability of ethical review.

关 键 词：药物临床试验 伦理委员会 伦理审查能力 

分 类 号：R-052[医药卫生]