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Updated: Jan 22, 2026

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在临床试验中对儿科同意的报告标准化
Shizuko Takahashi1,2,3, Jerry Menikoff1
1Centre for Biomedical Ethics (CBmE), National University of Singapore, Yong Loo Lin School of Medicine, Singapore.
Pediatrics
|January 21, 2026
概括
临床研究中的儿科同意文件不一致且稀少,经常嵌入父母同意中. 需要标准化报告,以确保儿童的安全.
科学领域:
- 儿科伦理学 儿科伦理学
- 临床试验方法论 临床试验方法论
- 研究诚信研究诚信
背景情况:
- 伦理共识强调儿科同意,但其在临床研究中的记录是不一致的.
- 目前的做法显示,小儿科试验中如何获得,放弃或取消同意的报告不足.
- 在同意程序中缺乏透明度会损害儿童参与的伦理问责和评估.
研究的目的:
- 检查临床研究中儿科同意实践的系统性报告不足情况.
- 分析儿童瘤学试验中同意如何记录.
- 为改进同意文件标准提出建议.
主要方法:
- 对儿科瘤学试验注册表的审查.
- 对知情同意表格的分析.
- 检查已发表的关于儿科同意的研究研究.
主要成果:
- 儿科同意往往嵌入父母同意,缺乏详细的文件.
- 观察到在不同研究中对同意过程的解释和应用不一致.
- 报告不足阻止了对儿童知情参与和异议机会的评估.
结论:
- 最低报告标准对于评估儿科研究中的伦理同意实践至关重要.
- 审判登记册和日志应采用关于记录同意,不同意和决议的要求.
- 标准化,适合发育的同意文件对于尊重儿童的声音和确保伦理研究和临床护理至关重要.
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