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我国伦理委员会网络会议审查现状调查与分析

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目的 为伦理委员会网络会议审查的规范、有效开展提供参考。方法 通过调查问卷收集国内医疗机构伦理委员会 2020 年 1 月至 6 月的网络会议审查开展情况,分析网络会议审查模式在临床试验伦理审查中的应用现状及存在的问题,并提出针对性建议与对策。结果 参与调查的 64 家机构中,有 24 家机构使用网络会议审查,有 59 家机构会继续或开始使用网络会议审查。存在网络稳定性、委员的签到和投票形式的规范性、网络会议审查的保密性、委员讨论的充分性等问题。结论 网络会议审查是伦理审查的重要补充形式。应建立完善的伦理网络会议审查相关法规或指引,建立标准操作规程与培训规范。
Investigation and Analysis of Review Status of Ethics Committee Online Meeting
Objective To provide a reference for the standardized and effective review of ethics committee online meetings.Methods A questionnaire survey was conducted on the online meeting review carried out by domestic medical institutions'ethics committees from January to June 2020 to analyze the current application status and existing problems of the online meeting review mode in clinical trial ethics review,and targeted suggestions and countermeasures were put forward.Results Among the 64 institutions involved in the investigation,24 institutions used online meeting review,and 59 institutions would continue or start to use online meeting review in future work.However,there are still some problems in terms of network stability,standardization of attendance and voting forms for committee members,confidentiality of online meeting review,and adequacy of committee discussions.Conclusion Online meeting review is one of the important supplementary forms of ethical review.but there are still many difficulties and challenges in standardizing and effectively conducting it.It is recommended to establish and improve relevant laws or guidelines for ethical online meeting review,and to establish standard operating procedures and standardized training.

ethics committeeethical reviewonline meeting review

刘雪丽、唐晓璇、赵鹏、侯百玉

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康复大学青岛中心医院·山东省青岛市中心医院,山东 青岛 266042

山东省青岛市胸科医院,山东青岛 266043

山东省青岛市第八人民医院,山东 青岛 266121

伦理委员会 伦理审查 网络会议审查

山东省青岛市市级临床重点专科建设项目

青卫政字[2022]6号

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(15)