药物临床试验伦理审查体系医疗机构管理的现况调查研究  

Across-Sectional Investigation on the Management of Medical Institutions in the Ethical Review System of Drug Clinical Trial

作　　者：余中光[1] 谢洁琼[2] 陆麒[3] 黄瑾 李素娟[5] 吴翠云[6] 陈虎[7] 刘海涛 熊宁宁[9] YU Zhongguang;XIE Jieqiong;LU Qi;HUANG Jin;LI Sujuan;WU Cuiyun;CHEN Hu;LIU Haitao;XIONG Ningning(Office of Academic Research, China-Japan Friendship Hospital, Beijing 100029;Advanced Research Institute of China Food and Drug Administration Institute, Beijing 100073;Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200127, China;Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437;Jinan Central Hospital, Jinan 250013, China;Huashan Hospital Affiliated to Fudan University, Shanghai 200040, China;Cangzhou Central Hospital, Cangzhou 061001, China;Jansen (China) Research & Development Center, Johnson & Johnson (China) Investment Ltd,Shanghai, 200233,China;Affiliated Hospital of Nanjing University of TCM, Nanjing 210029, China)

机构地区：[1]中日友好医院科研处,北京100029 [2]国家食品药品监督管理总局高级研修学院,北京100073 [3]上海交通大学医学院附属仁济医院,上海200127 [4]上海中医药大学附属岳阳中西医结合医院,上海200437 [5]济南市中心医院,山东济南250013 [6]复旦大学附属华山医院,上海200040 [7]沧州市中心医院,河北沧州061001 [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208-212,共5页Chinese Medical Ethics

摘　　要：药物临床试验伦理审查体系中的医疗机构管理是受试者保护的重要环节之一。采用调查问卷的方式,收集我国354家医疗机构在药物临床试验伦理审查体系中的管理现况,包括研究项目管理、研究利益冲突管理、合同管理、经费管理、培训管理、质量管理、伦理委员会组建与换届、伦理委员会资源、伦理审查的独立性以及伦理审查的透明性等要素,分析医疗机构履行受试者保护和对伦理委员会规范管理的职责情况并提出相应的建议。The management of medical institutions in the ethical review system of drug clinical trials is one of the important links in the protection of subjects. By means of questionnaires, the management status of 354 medical institutions in the ethical review system of drug clinical trials in China was collected, including research project management, conflict of interest management, contract management, fund management, training management, quality management, establishment and renewal of ethics committees, resources of ethics committees, independence of review and transparency of ethical review. To analyze the situation of medical institutions in fulfilling the duties of subject protection and normative management of ethical committees and put forward corresponding suggestions.

关 键 词：药物临床试验 伦理委员会 伦理审查体系 

分 类 号：R-052[医药卫生]