为研究提供标准化的跨部门数据访问协议模板:在可信的研究环境中提供数据访问的核心原则
Rachel Brophy1, Ester Bellavia1, Maeve Groot Bluemink2
1Health Data Research UK, Gibbs Building, 215 Euston Road, London, NW1 2BE.
International journal of population data science
|February 29, 2024
概括
一个新的标准化数据访问协议 (DAA) 对于可信的研究环境 (TREs) 简化了健康研究的安全数据访问. 这旨在加快项目批准并增强数据保护信任.
科学领域:
- 医疗信息学 医疗信息学
- 数据治理数据治理
- 研究伦理学研究伦理学
背景情况:
- 值得信赖的研究环境 (TREs) 是安全的平台,可以在健康研究中访问敏感数据.
- 当前的数据访问协议 (DAA) 往往是漫长,复杂的,并导致研究延迟.
- 在DAA中过时的条款阻碍了有效的法律审查和项目启动.
研究的目的:
- 为英国可信研究环境 (TREs) 制定标准化的数据访问协议 (DAA).
- 根据"五个安全框架"优化TREs中的数据科学应用程序的DAA.
- 建立TREs中可靠的数据访问的核心原则.
主要方法:
- 由英国卫生数据研究联盟的泛英国数据治理指导小组领导的开发.
- 通过对现有的TRE DAA和公众/利益相关者商进行比较来获取信息.
- 定义了TREs的核心数据访问原则.
主要成果:
- 已经定义了TRE数据访问的核心原则.
- 这些原则与英国TRE的常见DAA条款相匹配,附有可定制附件.
- 纳入了公众参与和参与调查结果.
结论:
- 这些原则构成了标准化英国TRE DAA模板的基础.
- 该模板旨在建立信任,并为研究人员和公众提供清晰度.
- 预计广泛采用将通过更快地批准项目来加速健康数据研究.
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