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在紧急研究中的知情同意. 对于急性心肌梗塞的医院前血栓抑制疗法
P S Grim1, P A Singer, G P Gramelspacher
1Section of Cardiology, University of Chicago Hospitals, IL 60637.
JAMA
|July 14, 1989
概括
在医疗紧急情况下获得临床研究的知情同意是具有挑战性的. 拟议的"两步同意"方法允许在保护患者权利的同时进行紧急研究.
科学领域:
- 医学伦理 医学伦理
- 临床研究 临床研究
- 紧急医疗 紧急医疗
背景情况:
- 在伦理临床试验中,知情同意是必不可少的,但在紧急情况下具有挑战性.
- 目前的联邦法规缺乏明确的指导,用于涉及有意识患者的紧急研究.
- 现有的方法包括避免研究,省略同意,或使用推迟/习惯性同意.
研究的目的:
- 检查在医疗紧急情况下从有意识的患者获得知情同意的复杂性.
- 提出一种替代方法,以道德的方式进行紧急临床研究.
- 在时间敏感的医学研究中解决知情同意的伦理困境.
主要方法:
- 分析紧急知情同意的挑战.
- 案例说明使用医院前血栓解压疗法用于心肌梗塞的试点试验.
- 关于一种新的"两步同意"流程的建议和讨论.
主要成果:
- 联邦法规对有意识患者的紧急研究提供了不足的指导.
- 确定了紧急同意的四种常见但可能存在问题的方法.
- 一个"两步同意"模型被提出为一个可行的替代方案.
结论:
- "两步同意"过程提供了一种方法来进行至关重要的紧急研究.
- 这种方法旨在保护研究参与者的权利和自主权.
- 它为未来的伦理紧急临床试验设计提供了一个框架.
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