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河南省医疗机构伦理委员会建设现状分析

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目的 了解河南省医疗机构伦理委员会建设情况,针对当前存在问题提出相应对策,为推进河南省医疗机构伦理委员会规范化建设提供政策参考.方法 2022年9月-12月,通过医学研究登记备案信息系统面向河南省医疗机构调查其伦理委员会建设情况、伦理审查情况、受试者权益保护及利益冲突管理情况,运用SPSS 26.0软件进行统计分析.结果 共有95家医疗机构接受调查,其中有91家医院,疾病预防控制中心、血液中心等4家;本研究共有117个伦理委员会,其规章制度建设情况良好,合格占比均>80%,92.31%的伦理委员会拥有独立办公资源配备;项目审查程序符合标准操作规程,审查运行总体良好,67个伦理委员会建立多中心研究伦理审查协作机制;不同级别医疗机构及不同归属医疗机构伦理委员会建设情况比较,三甲医院或省属机构整体建设情况优于二级医院或区县属机构(均P<0.05).结论 河南省医疗机构伦理委员会建设较规范,总体运行良好,但伦理审查和受试者权益保护及利益冲突方面仍有一定优化空间.建议加强伦理审查知识培训,完善伦理审查信息平台建设,建立区域伦理委员会认证体系.
Analysis of construction status of ethics committees in medical institutions in henan province
Objective To understand the construction of the ethics committee of medical institutions in Henan province,put forward corresponding countermeasures for the current problems,and provide policy references for promoting the standardization of the ethics committee of medical institutions in Henan province.Methods From September to Decem-ber 2022,the construction of ethics committees,ethical review,protection of subjects'rights and interests,and conflict of interest management were investigated by medical institutions in Henan province through the medical research registra-tion and filing information system,and SPSS 26.0 software was used for statistical analysis.Results A total of 95 med-ical institutions were surveyed,including 91 hospitals,4 including the center for disease control and prevention,and the blood central.A total of 117 ethics committees were surveyed in this study,and their rules and regulations were well es-tablished,with more than 80%of them being qualified,and 92.31%of them having independent office resources.The project review process was in line with the standard operating procedures,the review was generally good,and 67 ethics committees had established a collaborative mechanism for multi-center research ethics review.Compared with the con-struction of ethics committees of different levels of medical institutions and different subordinate medical institutions,the overall construction of tertiary hospitals or provincial institutions was better than that of secondary hospitals or district and county institutions(all P<0.05).Conclusion The construction of the ethics committee of medical institutions in Henan province is relatively standardized and generally operates well,but there is still some room for optimization in the aspects of ethical review,protection of subjects'rights and interests,and conflict of interest.It is recommended to strengthen the training of ethical review knowledge,improve the construction of an ethical review information platform,and establish a certification system for regional ethics committees.

Ethics committeeMedical institutionsSystem constructionEthical review

梁淑英、张月华、尹珊珊、马楠

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河南省医学科学院,郑州 450003

郑州大学公共卫生学院,郑州 450001

伦理委员会 医疗机构 制度建设 伦理审查

2024

医药论坛杂志
中华预防医学会,河南省医学情报研究所

医药论坛杂志

影响因子:0.47
ISSN:1672-3422
年,卷(期):2024.45(22)