北京地区医疗卫生机构人体研究伦理管理评价指标体系的应用研究  

Thoughts on Application of Evaluation Index System on Human Research Ethics Management in Beijing Medical Institutions

作　　者：胡正娟[1] 李义庭[2] 刘芳[1] 彭晓霞[3] 孙莹炜[1] 马小龙[4] 訾明杰[5] 张卓然[6] 王美霞[7] 母双[8] HU Zhengjuan LI Yiting LIU Fang PENG Xiaoxia SUN Yingwei MA Xiaolong ZI Mingfie ZHANG Zhuoran WANG Meixia MU Shuangs(Marxism Study Division, Capital Medical University, Beifing 100069, China School of Health Management and Education, Capital Medical University, Beifing 100069, China Center for Clinical Epidemiology and Evidence Based Medicine, Beijing Children＇s Hospital, Capital Medical University, Beijing 100045, China Equipment and Laboratory Management Department of Capital Medial University, Beijing 100069, China Medical Ethics Committee of Xiyuan Hospital, China Academy of Traditional Chinese Medicine, Beijing 100091, China Medical Service of Xuan Wu Hospital, Capital Medical University, Beijing 100053 ,China National Agency for Clinical Trials of Drugs, Belting You An Hospital, Capital Medical University, Beijing 100069, China Medical Ethics Committee of Peking University People＇s Hospital, Beijing 100044, China)

机构地区：[1]首都医科大学马克思主义学部,北京100069 [2]首都医科大学卫生管理与教育学院,北京100069 [3]首都医科大学附属北京儿童医院临床流行病与循证医学中心,北京100045 [4]首都医科大学设备与实验室管理处,北京100069 [5]中国中医科学院西苑医院医学伦理委员会,北京100091 [6]首都医科大学宣武医院医务处,北京100053 [7]首都医科大学附属北京佑安医院国家药物临床试验机构,北京100069 [8]北京大学人民医院医学伦理委员会,北京100044

出　　处：《中国医学伦理学》2017年第6期737-741,共5页Chinese Medical Ethics

摘　　要：目的建立北京地区医疗卫生机构人体研究伦理管理评价指标体系并进行应用研究。方法通过专家小组共识确定评价指标体系,并在四家医疗卫生机构进行实证研究。结果经过三轮专家咨询,确立了北京地区医疗卫生机构人体研究伦理管理评价指标体系,包括:6个一级指标,16个二级指标和39个三级指标。四家医疗卫生机构的实证研究结果表明评价指标体系符合机构的实际、可操作性强、区分度明显。结论建立的评价指标体系科学合理、具有良好的效度、信度、可操作性和区分度。Objective： This thesis aims to construct the evaluation index system ethics management in Beijing medical institutions for application research. Method： The author applied the evaluation system which was agreed and adjusted by expert groups in four medical and health institutions. Result： After three rounds of expert groups have reached the agreement, the Evaluation Index System on Human Research Ethics Management in Beijing Medi- cal Institutions is established, which contains 6 first - class indicators, 16 second - class indicators and 39 third - class indicators. The application on four medical and health institutions show that the evaluation index system is practical, operable and is of high degree of distinction. Conclusion ： The evaluation index system is scientific, rea-sonable, practical and is of high degree of validity, credibility and distinction.

关 键 词：医疗卫生机构 伦理管理 评价指标体系 

分 类 号：R-052[医药卫生]