医疗机构伦理审查委员会独立性评价指标体系构建  

Construction of the Independent Evaluation Index System for the Medical Institution Ethic Review Committee

作　　者：吴爵 蒋辉 吴少平 WU Jue;JIANG Hui;WU Shao-ping(Ministry of Science and Education,Sichuan Taikang Hospital,Chengdu 610213,China)

机构地区：[1]四川泰康医院科教部,四川成都610213 [2]福建医科大学附属漳州市医院科教部,福建漳州363000

出　　处：《医学与哲学》2023年第11期16-19,共4页Medicine and Philosophy

基　　金：2020年四川省哲学社会科学重点研究基地四川省应用心理学研究中心项目(CSXL-202A15);2022年雅安市科学技术局雅安市应用技术研究与开发项目(社发类重点)。

摘　　要：伦理审查委员会独立性是保障伦理审查过程及决策的科学性与伦理合理性的重要措施,也是保护受试者安全与权益的基本要求。通过文献检索、法规解读、专家小组讨论、德尔菲专家函询法进行筛选指标,确定医疗机构伦理审查委员会独立性评价指标体系及各指标权重,最终形成的指标体系共3项一级指标,11项二级指标,37项三级指标。该指标体系从伦理审查委员会设置、运行、内涵建设三个维度,建立了以独立性为框架的科学全面的独立性评价指标体系,为建设与评价伦理审查委员会独立性提供参考。The independence of the ethic review committee is an important measure to ensure the scientific and ethical rationality of the ethical review process and decision-making,and is also a basic requirement for protecting the safety and rights of subjects.Through literature search,regulatory interpretation,expert group discussion,and Delphi expert consultation,indicators were selected to determine the independent evaluation index system and weights of each indicator for the medical institution ethic review committee.The final indicator system consists of 3 primary indicators,11 secondary indicators,and 37 tertiary indicators.This indicator system establishes a scientific and comprehensive independent evaluation indicator system based on independence from three dimensions:the establishment,operation,and connotation construction of the ethic review committee,providing reference for the construction and evaluation of the independence of the ethic review committee.

关 键 词：伦理审查委员会 独立性 评价指标体系 

分 类 号：R-05[医药卫生]