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[患者对研究方案审查的贡献]
Flavie Mathieu1, Marie Lanta2, Martine Bungener3
1Collège des relecteurs de l'Inserm, service sciences et société, département de l'information scientifique et de la communication (DISC), Paris, France.
Medecine sciences : M/S
|June 30, 2023
概括
患者参与研究伦理学始于20世纪90年代的艾滋病倡导团体,赋予患者在临床研究中的权力. 这篇文章探讨了通过两个关键的法国患者主导的倡议来探索这种演变.
科学领域:
- 医学伦理 医学伦理
- 临床研究治理治理 临床研究治理
- 患者倡导 患者倡导
背景情况:
- 患者参与研究伦理学在20世纪90年代出现,由法国艾滋病患者协会带头.
- 这标志着在直接影响患者的研究中承认患者代理权的重大转变.
- 历史背景凸显了对患者参与科学努力的日益增长的需求.
研究的目的:
- 描述患者在研究伦理学中的解放及其对研究演变的影响.
- 分析增加患者参与临床研究协议的后果.
- 从法国两项特定的患者主导的研究倡议中吸取教训.
主要方法:
- 对法国两个不同的患者参与计划的案例研究分析.
- 检查"临床研究患者委员会" (成立于1998年).
- 对"Inserm校长学院" (2007年成立) 的分析.
主要成果:
- 建立患者委员会显然影响了研究协议管理.
- 这些举措代表了将患者观点纳入研究伦理学的具体步骤.
- 这些经验突出了患者驱动的研究监督的实际实施和结果.
结论:
- 患者参与对于伦理和相关的临床研究至关重要.
- 患者参与的演变意味着研究治理的范式转变.
- 这些模型为促进全球患者参与提供了有价值的见解.
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