[对无法提供知情同意的患者参与重症监护和急诊医学研究的建议 (科隆模型) ]
M Kochanek1, G Grass2, B Böll3
1Medizinische Fakultät und Universitätsklinik Köln, Med. Klinik I für Innere Medizin, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIO), Universität zu Köln, Kerpener Str. 62, 50937, Köln, Deutschland. matthias.kochanek@uk-koeln.de.
Medizinische Klinik, Intensivmedizin und Notfallmedizin
|September 29, 2023
概括
在紧急医疗中为失能患者进行临床试验的导航是复杂的. 一个新的共识模型确保了患者安全和法律明确性,用于涉及那些无法同意的人的研究.
科学领域:
- 紧急医疗 紧急医疗
- 临床研究伦理学
- 医疗法 法律 医疗法
背景情况:
- 医生,伦理委员会和法律专家之间存在分歧,关于将无法提供知情同意的患者纳入重症监护和急诊医学临床试验.
- 这些不同的观点在准备和执行涉及弱势群体的临床研究方面带来了挑战.
研究的目的:
- 开发一个共识模型,解决包括无法同意同意的患者在临床试验中的复杂问题.
- 为所有参与临床研究的利益相关者增强患者安全和法律确定性.
主要方法:
- 进行了全面的文献搜索,以确定现有的观点和挑战.
- 一个共识模型,即科隆模型,由医生,伦理委员会和法律专家共同开发.
主要成果:
- 科隆模型提供了一个框架,用于对无法提供同意的患者进行临床试验.
- 它旨在平衡科学研究的需求与保护患者权利和法律标准.
结论:
- 科隆模型为涉及失能患者的急诊医学临床试验的伦理和法律挑战提供了解决方案.
- 这种模式促进了患者安全,法律确定性,并促进了必要的科学研究.
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