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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,ethical 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.