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用人类对象进行研究的知情同意表格:是时候结束这个伪装了
1Boston University School of Public Health, Boston, MA, USA.
American journal of law & medicine
|March 24, 2025
概括
知情同意表格对于保护人类研究对象至关重要. 几十年的经验强调了精心制作的同意文件在伦理研究实践中的重要性.
科学领域:
- 生物伦理学生物伦理学
- 人类对象保护 人类对象保护
- 研究的法律方面 研究的法律方面
背景情况:
- 法律和健康科学中心成立于1974年,向国家保护人类受试者委员会提供了关于知情同意的法律背景文件.
- 这些论文是由乔治·J·安纳斯,芭芭拉·卡茨和叙述者撰写的,是人类研究伦理学的基础.
- 作者的50年职业生涯包括广泛参与机构审查委员会 (IRB) 和FDA的儿科研究咨询委员会,专注于人类受试者保护.
研究的目的:
- 反思人类研究伦理的演变和知情同意的作用.
- 检查保护研究对象的权利和福利的复杂性.
- 批判性地评估同意表格在确保全面主体信息方面的有效性.
主要方法:
- 对国家委员会提供的关于知情同意的法律背景文件的审查.
- 分析这本书"知情同意人类实验:受试者的困境".
- 个人反思50年与IRB和人类受试者保护活动的经验.
主要成果:
- 最初的项目为国家委员会提供了关键的法律背景.
- 作者的丰富经验导致了长期以来关于同意表格有效性的假设.
- IRB成员花费了大量时间来审查和讨论同意表格的精确措辞.
结论:
- 作者的早期工作为研究中知情同意的基本理解做出了贡献.
- 50年的实践突出了机构审查委员会和监管机构在人类受试者保护方面的核心作用.
- 持续需要确保同意表有效地向受试者提供研究方面的信息.
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