title: Data governance requirements for distributed clinical research networks: triangulating perspectives of diverse stakeholders.
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.
authors.affiliation: San Francisco State University, Health Equity Institute, San Francisco, California, USA Betty Irene Moore School of Nursing, University of California Davis, San Francisco, California, USA.
authors.forename: Katherine K
authors.initials: KK
authors.lastname: Kim
authors.affiliation: San Francisco State University, Health Equity Institute, San Francisco, California, USA.
authors.forename: Dennis K
authors.initials: DK
authors.lastname: Browe
authors.affiliation: San Francisco State University, Health Equity Institute, San Francisco, California, USA.
authors.forename: Holly C
authors.initials: HC
authors.lastname: Logan
authors.affiliation: Object Health, LLC, Walnut Creek, California, USA.
authors.forename: Roberta
authors.initials: R
authors.lastname: Holm
authors.affiliation: Object Health, LLC, Walnut Creek, California, USA.
authors.forename: Lori
authors.initials: L
authors.lastname: Hack
authors.affiliation: Division of Biomedical Informatics, University of California San Diego, La Jolla, California, USA.
authors.forename: Lucila
authors.initials: L
authors.lastname: Ohno-Machado
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D003195:Computer Communication Networks / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D016494:Computer Security; D003219:Confidentiality; D020408:Health Insurance Portability and Accountability Act; D017146:Models, Organizational; D014481:United States
keywords: Comparative Effectiveness Research; Data Sharing; Distributed Research Network; Governance Requirements; Stakeholder Engagement