Data governance requirements for distributed clinical research networks: triangulating perspectives of diverse stakeholders
Data governance requirements for distributed clinical research networks: triangulating perspectives of diverse stakeholders
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DOI：
10.1136/amiajnl-2013-002308
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发表时间：
2014-07-01
影响因子：
6.4
通讯作者：
Ohno-Machado, Lucila
中科院分区：
文献类型：
--
作者：
Kim, Katherine K.;Browe, Dennis K.;Ohno-Machado, Lucila
目前，有关分布式研究网络（DRN）治理要求开发的最佳实践的信息有限，这是一种促进临床数据重用并提高比较有效性研究及时性的新兴模式。大部分现有信息都是基于单一类型的利益攸关方，如研究人员或管理人员。本文报告了一种基于专家政策分析、机构领导人访谈和患者焦点小组相结合的三角方法来制定DRN数据治理要求。这种方法是从可扩展的国家网络的有效性研究，这导致了91个要求的例子说明。这些要求是根据公平信息实践原则（FIPP）和健康保险流通和责任法案（HIPAA）受保护与不受保护的健康信息进行分析的。这些要求涉及所有FIPP，展示了DRN的技术基础设施如何能够满足HIPAA法规，保护隐私，并提供值得信赖的研究平台。
There is currently limited information on best practices for the development of governance requirements for distributed research networks (DRNs), an emerging model that promotes clinical data reuse and improves timeliness of comparative effectiveness research. Much of the existing information is based on a single type of stakeholder such as researchers or administrators. This paper reports on a triangulated approach to developing DRN data governance requirements based on a combination of policy analysis with experts, interviews with institutional leaders, and patient focus groups. This approach is illustrated with an example from the Scalable National Network for Effectiveness Research, which resulted in 91 requirements. These requirements were analyzed against the Fair Information Practice Principles (FIPPs) and Health Insurance Portability and Accountability Act (HIPAA) protected versus non-protected health information. The requirements addressed all FIPPs, showing how a DRN's technical infrastructure is able to fulfill HIPAA regulations, protect privacy, and provide a trustworthy platform for research.