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研究中的知情同意的演变:从希波克拉底誓言到量身定制的同意
Jaime Fons-Martinez1,2, Carlos Murciano-Gamborino1, Javier Diez-Domingo1,2,3
1Vaccine Research Area, Foundation for the Promotion of Health and Biomedical Research of Valencia Region, FISABIO, Valencia, Spain.
Open research Europe
|September 16, 2024
概括
临床研究中的知情同意 (IC) 需要改进. 当前的流程往往无法保护参与者,突出需要以患者为中心的方法来提高伦理标准和研究质量.
科学领域:
- 临床研究伦理学
- 患者的自主权患者的自主权
- 在知情同意的过程中,提供知情同意.
背景情况:
- 在临床研究中,知情同意 (IC) 对于保护参与者的自主性至关重要.
- 尽管有道德上的进步,但IC指南往往没有得到充分实施,导致缺陷.
- 现有的同意实践可能会导致不道德的情况和参与者的理解不足.
研究的目的:
- 审查知情同意的历史演变.
- 介绍i-CONSENT项目的愿景,以改善研究中的IC理解.
- 为了确定一个新的以患者为中心的IC范式的组件.
主要方法:
- 对知情同意的历史审查.
- 对当前IC实践和缺陷的分析.
- 介绍了欧洲i-CONSENT项目的目标.
主要成果:
- 从历史上看,知情同意服务于法律/官僚目的,经常忽视患者的观点.
- 伦理准则在使IC成为更有效的工具方面取得了有限的成功.
- 目前的IC流程往往是官僚和法律,而不是以患者为中心.
结论:
- 需要从官僚化的IC流程转向优先考虑患者观点的流程.
- 调整知情同意程序的指导方针提供了专注于患者参与的替代方案.
- 采用以患者为中心的IC实践可以显著提高临床研究的质量.
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