在新生儿窒息症研究中,父母对信息和延迟与两阶段同意的观点
Christian A Maiwald1,2, Charlotte Rovers3, Annie Janvier4,5
1Department of Neonatology, University Children's Hospital Tübingen, Tübingen, Baden-Württemberg, Germany Christian.Maiwald@med.uni-tuebingen.de.
Archives of disease in childhood. Fetal and neonatal edition
|August 30, 2023
概括
在新生儿紧急情况中,父母更喜欢简短的口头同意 (SOC) 而不是推迟的同意 (DC). 然而,窒息的婴儿的父母对DC更开放,突出了在紧急研究同意中需要家长的意见.
科学领域:
- 新生儿研究伦理学
- 在临床试验中获得知情同意.
- 围产阶段窒息症管理管理
背景情况:
- "阿尔比诺试验"检查了阿洛普林醇对围产期窒息症中神经认知结果的影响.
- 在紧急情况下,产前知情同意是不可行的.
- 豁免同意 (WC) 或延期同意 (DC) 是道德上允许的紧急选择.
- 简短的口头/两步同意 (SOC) 是最近探索的一个替代方案.
研究的目的:
- 评估家长对延迟同意 (DC) 和短暂口头同意 (SOC) 的意见,用于紧急新生儿研究.
- 了解父母在围产期窒息的情况下对同意程序的偏好.
- 收集建议,以改善新生儿临床试验中的同意过程.
主要方法:
- 一项混合方法调查分析了家长对DC和SOC的看法.
- 参与者包括未来的父母,健康的新生儿的父母和窒息的婴儿的父母.
- 在2006年至2016年期间,在两个德国中心进行了调查.
主要成果:
- 55%的家长更喜欢SOC,而26%的家长认为没有信息的DC可能会破坏信任.
- 窒息婴儿 (PAx) 的父母更有可能支持DC,并对新生儿研究表示更大的赞赏.
- 大多数家长都希望获得预干预信息,并同意在紧急情况下立即介入.
结论:
- 关于同意紧急新生儿研究的家长意见各不相同,大多数人都赞成SOC.
- 具有新生儿紧急情况经验的父母对研究的信心增加.
- 纳入父母的观点对于设计道德和可接受的研究同意策略至关重要.
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