Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
QUEST - Center for Transforming Biomedical Research, Charité - University Medicine, Berlin Institute of Health (BIH), Anna-Louisa-Karsch-Str. 2, 10178, Berlin, Germany.
BMC Med Inform Decis Mak. 2020 Jul 11;20(1):157. doi: 10.1186/s12911-020-01177-z.
The promises of improved health care and health research through data-intensive applications rely on a growing amount of health data. At the core of large-scale data integration efforts, clinical data warehouses (CDW) are also responsible for data governance, managing data access and (re)use. As the complexity of the data flow increases, greater transparency and standardization of criteria and procedures are required in order to maintain objective oversight and control. Therefore, the development of practice oriented and evidence-based policies is crucial. This study assessed the spectrum of data access and use criteria and procedures in clinical data warehouses governance internationally.
We performed a systematic review of (a) the published scientific literature on CDW and (b) publicly available information on CDW data access, e.g., data access policies. A qualitative thematic analysis was applied to all included literature and policies.
Twenty-three scientific publications and one policy document were included in the final analysis. The qualitative analysis led to a final set of three main thematic categories: (1) requirements, including recipient requirements, reuse requirements, and formal requirements; (2) structures and processes, including review bodies and review values; and (3) access, including access limitations.
The description of data access and use governance in the scientific literature is characterized by a high level of heterogeneity and ambiguity. In practice, this might limit the effective data sharing needed to fulfil the high expectations of data-intensive approaches in medical research and health care. The lack of publicly available information on access policies conflicts with ethical requirements linked to principles of transparency and accountability. CDW should publicly disclose by whom and under which conditions data can be accessed, and provide designated governance structures and policies to increase transparency on data access. The results of this review may contribute to the development of practice-oriented minimal standards for the governance of data access, which could also result in a stronger harmonization, efficiency, and effectiveness of CDW.
通过数据密集型应用程序改善医疗保健和健康研究的承诺依赖于越来越多的健康数据。在大规模数据集成工作的核心，临床数据仓库（CDW）还负责数据治理，管理数据访问和（重新）使用。随着数据流的复杂性增加，需要更大的透明度和标准来规范标准和程序，以保持客观的监督和控制。因此，制定面向实践和基于证据的政策至关重要。本研究评估了国际上临床数据仓库治理中数据访问和使用标准和程序的范围。
我们对（a）关于 CDW 的已发表科学文献和（b）CDW 数据访问的公开信息（例如数据访问政策）进行了系统回顾。对所有纳入的文献和政策进行了定性主题分析。
最终分析纳入了 23 篇科学出版物和 1 份政策文件。定性分析得出了三个主要主题类别：（1）要求，包括接收方要求、再利用要求和正式要求；（2）结构和流程，包括审查机构和审查价值；（3）访问，包括访问限制。
科学文献中对数据访问和使用治理的描述具有高度的异质性和模糊性。在实践中，这可能会限制数据密集型方法在医疗研究和医疗保健中所需的有效数据共享，从而无法满足人们的高期望。缺乏关于访问政策的公开信息与透明度和问责制原则相关的伦理要求相冲突。CDW 应公开披露谁可以在什么条件下访问数据，并提供指定的治理结构和政策，以提高数据访问的透明度。本综述的结果可能有助于制定面向实践的最小数据访问治理标准，从而实现 CDW 的更强协调、效率和有效性。
