对临床研究的患者数据共享知情同意的分布式管理
Anh Pham1, Maxim Edelson2, Armin Nouri3
1UCSD Health Department of Biomedical Informatics, University of California San Diego, La Jolla, CA, USA.
Computers in biology and medicine
|August 9, 2024
概括
这项研究展示了一种基于区块链的临床研究知情同意系统. 该系统提供不变的同意记录和研究人员高效的数据访问,增强患者隐私和研究效率.
科学领域:
- 临床研究信息学 临床研究信息学
- 区块链技术应用的应用
- 数据隐私和安全数据隐私和安全
背景情况:
- 知情同意对于临床研究编排至关重要.
- 目前的系统在患者隐私和研究人员数据访问效率方面面临挑战.
- 需要一个不变的,自动化的同意匹配系统.
研究的目的:
- 为了证明基于以太坊的知情同意系统的可行性.
- 通过一个不变的审计跟踪来确保患者的隐私.
- 提高研究人员访问数据的效率.
主要方法:
- 模拟了一个多站点临床研究场景,每个站点有10,000个同意记录.
- 开发了一个区块链基础设施,用于在链上记录和查询同意的智能合约.
- 测量系统记录效率与基线相比,并通过详尽的查询验证准确性.
主要成果:
- 实现了每条记录每节点平均插入速度约为2秒.
- 在同意记录和查询方面证明了100%的准确性.
- 在外部验证中表现优于现有解决方案,并通过增加网络节点提高了效率.
结论:
- 确认了基于区块链的同意机制的技术可行性.
- 为患者提供不变的审计轨道,以增强信任和隐私.
- 为研究人员提供一种有效的队列识别和数据访问方法.
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