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.
作者
胡正娟
李义庭
刘芳
彭晓霞
孙莹炜
马小龙
訾明杰
张卓然
王美霞
母双
HU Zheng-juan LL Yi-ting LIU Fang et al(Marx School： of PhilOsophy ,Capital Medical University, Beijing 100069, China)
出处
《医学与哲学（A）》
北大核心
2017年第9期25-30,共6页
Medicine & Philosophy:Humanistic & Social Medicine Edition
关键词
医疗卫生机构
人体研究
伦理管理
评价指标体系
medical and health institution, research involving human SubjectS, ethics management i evaluation index system
