Data governance requirements for distributed clinical research networks: Triangulating perspectives of diverse stakeholders

Katherine K Kim, Dennis K. Browe, Holly C. Logan, Roberta Holm, Lori Hack, Lucila Ohno-Machado

Research output: Contribution to journalArticle

11 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)714-719
Number of pages6
JournalJournal of the American Medical Informatics Association
Volume21
Issue number4
DOIs
StatePublished - 2014

ASJC Scopus subject areas

  • Health Informatics

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