同意的规范性力量和研究风险的限制
Aaron Eli Segal1, David S Wendler1
1Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD 20892 USA.
Ethical theory and moral practice : an international forum
|October 25, 2024
概括
这项研究认为,成人研究风险的伦理限制源于知情同意本身,而不是公众看法等外部因素. 它确立了某些风险本质上是不可接受的,无论是否同意或公众信任考虑.
科学领域:
- 生物伦理学生物伦理学
- 研究伦理学研究伦理学
- 医学伦理 医学伦理
背景情况:
- 目前的研究法规缺乏对成年人同意的明确风险限制.
- 审查委员会经常认为某些风险过高,即使有同意.
- 风险限制的现有理由依赖于外部因素,如公众的信任.
研究的目的:
- 为限制成年人同意的研究风险提出替代理由.
- 为识别不可接受的研究风险提供更强大的概念基础.
- 探索知情同意在允许道德上有问题的风险方面的内部局限性.
主要方法:
- 对研究风险限制的伦理理由的概念分析.
- 检查知情同意和道德上允许的行为之间的关系.
- 对风险限制的外部理由进行批评,例如公众的信任.
主要成果:
- 对风险限制的外部理由是不够的,因为它们取决于公众的看法.
- 对成年人同意的研究风险的限制来自知情同意的内部约束.
- 知情同意对它可以在道德上允许的内容有固有的限制.
结论:
- 一些研究风险在伦理上是不可接受的,无论参与者是否同意或公众的反应.
- 一个强大的研究伦理框架必须承认可接受风险的固有限制.
- 这种内部理由为研究伦理审查提供了更稳定的基础.
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