在基因组学和其他以数据为中心的研究中考虑和披露群组风险:共同规则是否需要修订?
Carolyn Riley Chapman1, Gwendolyn P Quinn1, Heini M Natri2
1NYU Grossman School of Medicine.
The American journal of bioethics : AJOB
|November 27, 2023
概括
联邦法规需要更新,以保护研究中的集团利益,特别是人工智能和基因组数据. 关于机构审查委员会 (IRB),知情同意和豁免的现行规则需要重新考虑,以解决潜在的集团损害.
科学领域:
- 生物伦理学生物伦理学
- 研究伦理学研究伦理学
- 监管科学 监管科学
背景情况:
- 研究,特别是使用人工智能和基因组技术的以数据为中心的研究,对团体和第三方构成重大风险.
- 现有的美国联邦法规可能无法充分解决这些特定群体的伤害.
研究的目的:
- 探索美国联邦法规的适应,以更好地与当前的伦理思想保持一致,并保护研究中的集体利益.
- 确定共同规则中需要重新考虑的特定方面的集团利益.
主要方法:
- 分析关于机构审查委员会 (IRB) 风险/收益评估的共同规则的规定.
- 审查信息披露要求,在知情同意过程中对集团伤害进行审查.
- 对与集团利益相关的知情同意豁免标准的审查.
主要成果:
- 共同规则的框架要求关注IRB评估,知情同意披露和豁免标准,以更好地保护集团利益.
- 研究人员和IRB对潜在的集团损害的系统考虑至关重要.
结论:
- 研究人员和IRB必须在研究设计和审查中主动考虑集团伤害.
- 知情同意过程应包括关于潜在的群体危害的信息.
- 需要进一步的公开讨论,经验研究和规范分析,以完善保护研究集团利益的法规和政策.
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