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同意从电子健康记录共享数据到研究存储:限制,障碍和代理
Ève-Marie Roy1, Iva Georgieva2, Laurent Fradet3
1Faculty of Medicine, Université Laval, Quebec City, QC, Canada.
Acta psychologica
|June 20, 2025
概括
当未知未来数据使用时,获得有效的生物医学研究患者同意是具有挑战性的. 这项研究考察了电子健康和研究记录之间的数据共享,探索同意有效性和分级.
科学领域:
- 生物医学信息学 生物医学信息学
- 健康数据管理 管理健康数据
- 研究伦理学研究伦理学
背景情况:
- 在电子健康记录 (EHR) 中增加健康数据的数字化.
- 研究人员越来越需要访问人口健康数据进行研究.
- 患者同意在将数据从电子健康记录转移到电子研究记录 (ERR) 中的关键作用.
研究的目的:
- 分析EHR和ERR之间共享的数据的特征.
- 探讨在获得有效的患者同意的大规模数据研究方面的挑战.
- 调查数据共享分级同意模型的可行性.
主要方法:
- 跨截面,跨时间和跨空间数据特征的分析.
- 探索对同意有效性的法律和道德约束.
- 检查现有的同意模型和分级的可能性.
主要成果:
- 在EHR和ERR之间共享数据涉及复杂的数据特征.
- 预见所有研究结果和数据使用是很困难的,影响同意的有效性.
- 存在分级同意方法的潜力,以满足不断变化的研究需求.
结论:
- 验证未来的同意,使用大规模数据集进行不可预见的研究,会带来重大的伦理和实际障碍.
- 共享数据的特点 (跨截面,跨时间,跨空间) 复杂化了同意.
- 一个细微的,可能分级的,同意机制可能是必要的,以平衡研究需求与患者自主权.
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