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Updated: Sep 9, 2025

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Working with Human Tissues for Translational Cancer Research
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从广泛的同意到患者参与:同意管理和研究监督的框架
Anne Pelz1, Philipp Heinrich2, Gabriele Mueller3
1Institute for Medical Informatics and Biometry, Faculty of Medicine Carl Gustav Carus, TUD Dresden University of Technology, Fetscherstraße 74, 01307 Dresden, Germany.
Studies in health technology and informatics
|September 3, 2025
概括
这项研究引入了数据管理流程和基础设施,以提高使用临床数据的研究透明度. 患者可以跟踪他们的同意历史和数据使用情况, 促进更大的参与和信任.
科学领域:
- 医疗信息学
- 健康数据管理
- 患者参与研究
背景情况:
- 德国医学信息化倡议 (MII) 支持使用常规临床数据的研究.
- 广泛的同意框架被用来让患者参与研究.
- 目前的系统在患者同意和研究数据使用方面缺乏透明度.
研究的目的:
- 提出一个数据管理流程和参考基础设施.
- 提高患者在研究中的同意历史和数据使用方面的透明度.
- 让患者能够追踪他们参与研究的情况.
主要方法:
- 德累斯顿大学医院 (UKD) 的数据提供过程分析.
- 在广泛的同意下确定二次数据使用的角色和数据流.
- 评估现有MII工具的安全数据访问能力.
主要成果:
- 开发一个结构化的数据访问流程.
- 实施面向患者的应用程序的参考基础设施.
- 建立了患者获得同意和研究细节的安全基础.
结论:
- 现有的MII工具可用于以患者为中心的二次数据使用透明度.
- 开发的基础设施支持患者同意和数据的跟踪.
- 未来的工作将集中在可扩展性,访问控制和道德考虑上.
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