在涉及有意识障碍的人的研究中提供知情同意的做法
Ariane Lewis1, Saptharishi Lalgudi Ganesan2,3, Ralf J Jox4
1NYU Langone Health, New York, NY, USA. ariane.kansas.lewis@gmail.com.
Neurocritical care
|November 6, 2025
概括
对意识障碍 (DoC) 研究的知情同意缺乏一致的术语和关于风险的明确沟通. 开发共同的同意要素对于保护这个脆弱群体的自治至关重要.
科学领域:
- 神经科学是一个神经科学.
- 生物伦理学生物伦理学
- 临床研究 临床研究
背景情况:
- 治愈昏迷运动调查了涉及有意识障碍 (DoC) 个体的研究的知情同意.
- 了解当前的同意实践对于为这个弱势群体开发标准化的同意要素至关重要.
研究的目的:
- 分析在研究中使用的知情同意表格,用于与有意识障碍的人进行研究.
- 在这些同意表格中识别术语和风险沟通中的不一致性.
主要方法:
- 在2024年秋季收集了来自康复昏迷运动成员和clinicaltrials.gov的58份同意表格.
- 关于研究细节,同意流程和DOC相关考虑的抽象数据.
- 利用描述性统计来审查和整理抽象的数据.
主要成果:
- 分析了43种独特的同意表格,用于涉及DOC患者的研究.
- 发现脑损伤/意识/DoC. 的术语不一致 (62个术语).
- 很少有表格 (10%) 提及隐藏的意识评估,更少的表格 (7%) 提及同意能力.
- 虽然81%的人提到经验风险,但只有6%的人详细介绍了DoC患者面临的挑战.
结论:
- 对DoC研究的同意表格在术语,能力评估和风险沟通方面存在重大不一致.
- 显然需要共同的同意要素来提高透明度和一致性.
- 标准化元素将更好地保护有意识障碍的个体在参与研究期间的自主权.
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