利益相关者对实用临床试验数据共享的看法:满足新出现的要求所面临的意外挑战
Stephanie R Morain1,2, Juli Bollinger1, Kevin Weinfurt3
1Berman Insitute of Bioethics Johns Hopkins University Baltimore Maryland USA.
Learning health systems
|January 22, 2024
概括
从实用临床试验 (PCT) 中共享数据涉及道德挑战,特别是关于同意和患者偏好. 导航这些需要敏感的政策,以PCT特定的问题,有效的数据共享.
科学领域:
- 临床试验 临床试验
- 数据科学数据科学数据科学
- 生物伦理学生物伦理学
背景情况:
- 越来越多地主张广泛共享非识别的参与者级临床试验数据.
- 实用临床试验 (PCT) 为数据共享带来了独特的伦理挑战.
- 现有的学术研究还没有完全解决导航PCT数据共享的实际经验.
研究的目的:
- 探索共享PCT的非识别的个人级数据的伦理问题和实际挑战.
- 了解利益相关者与PCT数据共享倡议的经验.
- 确定PCT数据共享中的伦理挑战是如何导航的.
主要方法:
- 与参与PCT数据共享的关键利益相关者进行了40次半结构化访谈.
- 雇员有目的的抽样,以确保受影响群体的多样化代表性.
- 采用综合方法对面试数据进行专题分析.
主要成果:
- 确定了五个关键主题:同意豁免的挑战,关于患者偏好的相互矛盾观点,促进尊重的做法,对风险/负担的担忧以及对益处的不同意见.
- 突出了在平衡数据共享期望与PCT特定的伦理考虑方面的未解决的紧张关系.
- 揭示了与共享PCT数据相关的好处和风险的不同观点.
结论:
- 为了满足广泛的PCT数据共享的期望,需要解决固有的伦理紧张关系.
- 数据共享政策必须敏感于PCT的独特的伦理和实际考虑.
- 需要进一步研究和分享成功的导航策略,以完善PCT数据共享实践.
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