弥合数字健康研究中的伦理差距:与NIH指导一致的知情同意框架
Rahma Rizky Alifia1, Malihe Sadeghi2,3, Maheswari Eluru2
1College of Health Solutions, Arizona State University, Phoenix, AZ, 85004, USA. ralifia@asu.edu.
BMC medical ethics
|October 8, 2025
概括
数字健康研究的知情同意表格往往缺乏关键的伦理元素,特别是关于技术风险的. 一个新的框架旨在加强这些研究中的参与者保护,透明度和公平性.
科学领域:
- 数字健康数字健康
- 临床研究伦理学
- 在知情同意的情况下同意.
背景情况:
- 数字健康技术正在彻底改变临床研究.
- 现有的知情同意实践不足以解决这些技术带来的伦理风险.
- 需要在数字健康研究中改善参与者保护.
研究的目的:
- 开发和评估数字健康研究的全面的道德同意框架.
- 为了提高透明度,公平性和参与者保护.
- 解决数字健康技术带来的独特的伦理风险.
主要方法:
- 开发了一个同意框架,包含63个属性,涵盖四个领域:同意,研究人员许可,研究人员义务和技术.
- 进行了主题分析,并审查了来自数字健康研究的25份知情同意表格.
- 使用描述性统计数据来评估框架的调整,并确定缺失的伦理元素.
主要成果:
- 没有任何经过审查的同意表格完全符合所有伦理要求,特别是在技术特定风险方面.
- 要求属性的完整性仅达到73.5%.
- 确定了四个新的伦理突出的同意要素:商业利分享,研究信息披露,研究期间的结果共享和数据删除请求.
结论:
- 在保护数字健康研究参与者方面,仍然存在重大伦理差距.
- 目前的同意实践需要提高公平性和全面性.
- 开发的框架是提高透明度,自治和正义的实际工具.
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