关于集群随机试验的伦理设计和进行的"太华声明"中的差距:引用分析显示需要更新的伦理准则
Cory E Goldstein1,2, Jessica du Toit3, Nicholas B Murphy4,5
1Methodological and Implementation Research Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada. cogoldstein@ohri.ca.
Research integrity and peer review
|June 17, 2025
概括
关于集群随机试验的伦理设计和进行的"太华声明"需要更新,因为在其文献中发现了24个伦理差距. 这些发现将为即将修订的集群随机试验伦理准则提供信息.
科学领域:
- 生物伦理学生物伦理学
- 临床试验方法论 临床试验方法论
- 公共卫生研究伦理 公共卫生研究伦理
背景情况:
- 集群随机试验 (CRT) 对于评估健康干预至关重要,但存在独特的伦理挑战.
- 2012年"太华声明"为七个领域的伦理CRT行为提出了15项建议.
- 不断发展的CRT设计需要更新的伦理指导.
研究的目的:
- 通过分析引用"太华宣言"的文献来识别现有的"太华宣言"的差距.
- 为即将修订的关于伦理CRT设计和行为的"太华声明"提供信息.
主要方法:
- 在Google Scholar,Scopus和Web of Science中进行了系统的文献搜索.
- 引用"太华宣言"或相关论文的出版物被包括在内,数据由四位评论员提取.
- 专题分析和语义编码用于识别和分类"太华宣言"领域内的伦理差距.
主要成果:
- 对53篇文章的分析揭示了"太华宣言"中的24个明显的伦理缺陷.
- 发现缺陷的关键领域包括CRT设计的合理性,研究伦理委员会审查,参与者识别,知情同意,守门员角色,利益危害评估和公平问题.
- 在每个领域中确定了特定数量的差距,突出了需要最多关注的领域.
结论:
- 鉴定到的24个缺陷强调了迫切需要更新"太华宣言".
- 这些发现,结合正在进行的实证工作和患者/公众的意见,将有助于修订CRT的伦理准则.
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