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Research Data Governance, Roles, and Infrastructure

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Clinical Research Informatics

Part of the book series: Health Informatics ((HI))

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Abstract

This chapter explores the concepts, requirements, structures, and processes of data or information governance. Data governance comprises the principles, policies, and strategies that are commonly adopted, the functions and roles that are needed to implement these policies and strategies, and the consequent architectural designs that provide both a home for the data and, less obviously, an operational expression of policies in the form of controls and audits. This speaks to the “What?” and “How?” of data governance, but the “Why?” is what justifies the extraordinary efforts and lengths organizations must go to in the pursuit of effective data governance. This receives a fuller answer in this chapter; in brief, information is a valuable asset whose value is threatened both by loss of integrity, the principal internal threat, and by its potential for theft or leakage, compromising privacy, business advantage, and failure to meet regulatory requirements—the external threats. Internal and external threats are not quite so neatly distinguished in real life, as we shall see in this chapter.

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Notes

  1. 1.

    This simple list was promoted to public bodies in the United Kingdom by the now dissolved Audit Commission. The elaboration in this chapter is the author’s, based on numerous other contributions.

  2. 2.

    Instituted following the Caldicott Committee. Report on the Review of Patient-Identifiable Information. December 1997. UK Department of Health

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Acknowledgments

The author acknowledges the lasting contribution to his understanding of the research data governance by successive leadership and members of the American Medical Informatics Association’s (AMIA) Clinical Research Informatics Working Group (CRI-WG) and Ethical, Legal and Social Issues Working Group (ELSI-WG), and through his participation in AMIA’s Public Policy, Ethics, and Diversity, Equity and Inclusion Committees. The first edition of this chapter formed the basis for an AMIA conference workshop on three occasions. Special thanks are due to my co-presenters, esp. Kate Fultz Hollis, Lincoln Sheets, Trent Rosenbloom, Melissa Haendel, and Chris Chute, and to the participants for their insightful discussions. The section on “Defense of Data” has benefited greatly from the American Statistical Association’s Committee on Privacy and Confidentiality and its comparison of the HIPAA Privacy Rule and the Common Rule [36]. The section on roles owes a great deal to the paper by Sanchez Pinto et al. [37] and in particular to the three CRIOs who spoke at the workshop from which the paper was developed, Bill Barnett, Peter Embi, and Umberto Tachinardi. Also fellow panelists at AMIA Summit 2018, Harold Lehmann, Kate Fultz Hollis, Bill Hersh, Jihad Obeid, Megan Singleton, and Umberto Tachinardi. The work of John Holmes [38,39,40] was also influential. The implementation section benefited from Adam Tobias and colleagues’ work at USF [34]. More recently the IEEE Standards Working Group P2863 on AI Governance, the CD2H maturity model community, my co-authors on Defining AMIA’s AI Principles [41], and Drs. Kenneth Goodman and Diane Korngiebel have helped me put this work in a wider context. Of course, none of these authors bears any responsibility for errors or misunderstandings that may have crept into this chapter.

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Authors and Affiliations

  1. Outcomes Research Network, NorthShore University HealthSystem, Research Institute, Evanston, IL, USA

    Anthony Solomonides

  2. Institute for Translational Medicine, University of Chicago, Chicago, IL, USA

    Anthony Solomonides

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  1. Anthony Solomonides
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Editors and Affiliations

  1. Learning Health Sciences, University of Michigan School of Medicin, Ann Arbor, MI, USA

    Rachel L. Richesson

  2. School of Information, University of South Florida, Tampa, FL, USA

    James E. Andrews

  3. Medical Informatics and Clinical Epidemiology, Oregon Health and Science University, Portland, OR, USA

    Kate Fultz Hollis

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Solomonides, A. (2023). Research Data Governance, Roles, and Infrastructure. In: Richesson, R.L., Andrews, J.E., Fultz Hollis, K. (eds) Clinical Research Informatics. Health Informatics. Springer, Cham. https://doi.org/10.1007/978-3-031-27173-1_11

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  • DOI: https://doi.org/10.1007/978-3-031-27173-1_11

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