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.
作者
余中光
谢洁琼
陆麒
黄瑾
李素娟
吴翠云
陈虎
刘海涛
熊宁宁
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)
出处
《中国医学伦理学》
2019年第2期208-212,共5页
Chinese Medical Ethics
