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构建  

The Construction of Evaluation Index System on Research Involving Human Subjects Ethics Management of Medical Institutions in Beijing

作　　者：胡正娟 李义庭[2] 刘芳 彭晓霞[3] 孙莹炜 马小龙[4] 訾明杰[5] 张卓然[6] 王美霞[7] 母双[8] HU Zheng-juan LL Yi-ting LIU Fang et al(Marx School： of PhilOsophy ,Capital Medical University, Beijing 100069, 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：《医学与哲学（A）》2017年第9期25-30,共6页Medicine & Philosophy:Humanistic & Social Medicine Edition

摘　　要：作者借鉴国内外关于伦理审查的法律法规和相关规定,参考AAHRPP认证和SIDCER认证的指标内容,遵循Donabedian的结构-过程-结果模式,从组织架构、制度规程、伦理审查、文档管理、监督管理、权益保护六个维度构建了北京地区医疗卫生机构伦理管理评价指标体系的初步框架。并通过三轮专家小组共识,确定了评价指标,共包括:6个一级指标、16个二级指标和39个三级指标。研究结果表明,建立的评价指标体系合理、科学、全面,具有可操作性,有重要的推广应用价值。According to national and international laws and regulations on ethical review and referring to the criteria of AAHRPP and SIDCER accreditation, the authors establishes the preliminary framework of the evaluation index system of ethics management in Beijing medical institutions, following the Donabedian process result model. This framework is formed by six dimensions, including organization structure, procedures, ethieal review, document management, supervision and protection of rights and interests. The evaluation index system contains six indicators, sixteen secondary index and thirty-nine three-level index, on which three rounds of expert groups have reached the agreement. The results show that the evaluation index system is sound, scientific, comprehensive, operable and of important appliCation value.

关 键 词：医疗卫生机构 人体研究 伦理管理 评价指标体系 

分 类 号：R-052[医药卫生]