Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2014 Jul-Aug;21(4):714-9.
doi: 10.1136/amiajnl-2013-002308. Epub 2013 Dec 3.

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

Katherine K Kim  1 , Dennis K Browe  2 , Holly C Logan  2 , Roberta Holm  3 , Lori Hack  3 , Lucila Ohno-Machado  4
Affiliations

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

Katherine K Kim et al. J Am Med Inform Assoc. 2014 Jul-Aug.

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.

Keywords: Comparative Effectiveness Research; Data Sharing; Distributed Research Network; Governance Requirements; Stakeholder Engagement.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Example of a distributed research network conceptual architecture.
See this image and copyright information in PMC

References

    1. Ohmann C, Kuchinke W. Future developments of medical informatics from the viewpoint of networked clinical research. Interoperability and integration. Methods Inf Med 2009;48:45–54 - PubMed
    1. Brown J, Holmes J, Maro J, et al. Design specifications for network prototype and cooperative to conduct population-based studies and safety surveillance. No 13 (Prepared by the DEcIDE Centers at the HMO Research Network Center for Education and Research on Therapeutics and the University of Pennsylvania Under Contract No HHSA29020050033I T05). Rockville, MD: Agency for Healthcare Research and Quality, 2009
    1. Brown JS, Holmes JH, Shah K, et al. Distributed health data networks: a practical and preferred approach to ulti-institutional evaluations of comparative effectiveness, safety, and quality of care. Medical Care 2010;48:S45–51 - PubMed
    1. Ohno-Machado L, Day M, Kim H, et al. Standards in the use of collaborative data networks or distributed data networks in patient centered outcomes research. Technical Report for PCORI RFAs Washington, DC: Patient Centered Outcomes Research Institute, 2013
    1. Manion FJ, Robbins RJ, Weems WA, et al. Security and privacy requirements for a multi-institutional cancer research data grid: an interview-based study. BMC Med Inform Decis Mak 2009;9:31. - PMC - PubMed

Publication types

MeSH terms