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生物医学研究中的口头同意:走向未来的标准实践?
Alycia Noë1, Emilie Vaillancourt1, Ma'n H Zawati1
1Centre of Genomics and Policy, Faculty of Medicine and Health Science, Victor Philip Dahdaleh Institure of Genomic Medicine, McGill University, Montreal, QC, Canada.
Frontiers in genetics
|March 17, 2025
概括
口头同意在人类受试者研究中越来越多地使用,特别是在COVID-19和罕见疾病方面. 本次审查倡导将口头同意流程正式化,以提供指导并确保一致的监管.
科学领域:
- 医学伦理 医学伦理
- 临床研究方法论 临床研究方法论
- 卫生政策 卫生政策
背景情况:
- 在人类受试者研究中,知情同意至关重要.
- 传统的书面知情同意是标准的,但在特定情况下受到挑战.
- 在COVID-19和罕见疾病研究等环境中,口头同意越来越普遍,引发了争论.
研究的目的:
- 审查目前口头同意是常见的医疗环境.
- 分析口头同意的优点和缺点.
- 检查围绕口头同意的立法和政策环境.
主要方法:
- 关于口头同意实践的文献综述.
- 分析现有的法律和政策框架.
- 支持和反对口头同意的论据的综合.
主要成果:
- 在特定的研究领域,口头同意日益成为一种规范.
- 确定的好处包括灵活性和可访问性.
- 确定的缺点包括文档方面的挑战和可能的胁迫.
结论:
- 关于口头同意的辩论应该结束.
- 立法者和政策制定者必须承认和正式表达口头同意.
- 正式化将使监管成为可能,并为临床医生研究人员提供指导.
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