Skip to main content
SpringerLink
Log in

Research Data Governance, Roles, and Infrastructure

  • Chapter
  • First Online:
Clinical Research Informatics

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

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 later in the chapter.

The American Medical Informatics Association (AMIA) Clinical Research Informatics Working Group (CRI-WG). Acknowledgements: Judy Logan, WG Chair 2014–2016; Abu Mosa, Monika Ahuja, Kris Benson, Shira Fischer, Lyn Hardy, Kate Fultz Hollis, Bernie LaSalle, Nelson Sanchez Pinto, Lincoln Sheets, Ana Szarfman, Chunhua Weng, Chair Elect 2018–2020.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 89.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Notes

  1. 1.

    Code of Federal Regulations 45 CFR part 46, subpart A, is known as the Federal Policy for the Protection of Human Subjects or the Common Rule. It is shared verbatim by a number of departments, hence “common.” See https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html.

  2. 2.

    As of this writing, the status is described in the announcement “HHS and 16 Other Federal Departments and Agencies Issue a Final Rule to Delay for an Additional 6 Months the General Compliance Date of Revisions to the Common Rule While Allowing the Use of Three Burden-Reducing Provisions during the Delay Period” (https://www.hhs.gov/ohrp/final-rule-delaying-general-compliance-revised-common-rule.html).

  3. 3.

    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 contributions from numerous authors.

  4. 4.

    At the time of writing, the Common Rule is subject to revision. A revised rule had been approved on the very last day of the Obama administration, but this was suspended for review by the incoming Trump administration. Recent (April 2018) indications are that the Obama rule may be amended before it is implemented.

  5. 5.

    The Obama rule and the revision still under current consideration do allow for broad consent in some cases. As embodied in this rule, broad consent is thought to place a considerable burden on the institution to maintain awareness and monitor its application.

  6. 6.

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

  7. 7.

    John Ladley. Data Governance: How to Design, Deploy, and Sustain an Effective Data Governance Program. Morgan Kaufmann, 2012. A readable, comprehensive guide to the broad spectrum of data governance—recommended.

    • David Plotkin. Data Stewardship: An Actionable Guide to Effective Data Management and Data Governance. Morgan Kaufmann, 2013. Puts the onus for data governance on data stewards; this may be somewhat narrow for healthcare institutions.

    • Helmut Schindlwick. IT Governance: How to Reduce Costs and Improve Data Quality through the Implementation of IT Governance. CreateSpace, 2017. Highly recommended by some business leaders, it seems to restrict its purview to IT-related matters.

    • Robert S. Seiner. Non-Invasive Data Governance. Technics Publications, 2014. Appears rather more authoritarian than its title may suggest.

References

  1. Donabedian A. Evaluating the quality of medical care. Milbank Q. 2005;83(4):691–729. Reprinted from The Milbank Memorial Fund Quarterly 44:3.2;166-203 (1966)

    Article  Google Scholar 

  2. AHIMA. Information Governance Principles for Healthcare (IGPHC). Available at: www.ahima.org/~/media/AHIMA/Files/HIM-Trends/IG_Principles.ashx.

  3. Martin PY, Turner BA. Grounded theory and organizational research. J Appl Behav Sci. 1986;22(2):141.

    Article  Google Scholar 

  4. Fahey L, Prusak L. The eleven deadliest sins of knowledge management. Calif Manag Rev. 1998;40(3):265–76. (“Error 3”). This precise formulation was given—repeated twice for emphasis—at a HICSS2000 keynote.

    Article  Google Scholar 

  5. Her QL, Malenfant JM, Malek S, Vilk Y, Young J, Li L, Brown J, Toh S. A query workflow design to perform automatable distributed regression analysis in large distributed data networks. eGEMs. 2018;6(1):1–11.

    Google Scholar 

  6. Health Insurance Portability and Accountability Act of 1996. Public Law 104–191. US Government Publishing Office. 1996. Available at: https://www.gpo.gov/fdsys/pkg/PLAW- 104publ191/pdf/PLAW-104publ191.pdf

  7. Whitman JQ. The two western cultures of privacy: dignity versus liberty. Yale Law J. 2004;113:1151–221. Available as Faculty Scholarship Series, Paper 649 at http://digitalcommons.law.yale.edu/fss_papers/649

    Article  Google Scholar 

  8. Warren SD, Brandeis LD. The right to privacy. Harv Law Rev. 1890;4(5):193–220.

    Article  Google Scholar 

  9. Viktor Mayer-Schonberger. Beyond privacy beyond rights – toward a systems theory of information governance. Calif Law Rev, 98:1853–1885 (2010). Available at http://scholarship.law.berkeley.edu/californialawreview/vol98/iss6/4.

  10. Laudon KC. Markets and privacy. Commun ACM. 39, 9:92–104

    Article  Google Scholar 

  11. Tobias A, Chackravarthy S, Fernandes S, Strobbe J AAMC Conference on Information Technology in Academic Medicine, Toronto, June 2016; also presented as an AMIA CRI-WG Webinar, October 2016.

    Google Scholar 

  12. https://www.gartner.com/it-glossary/information-governance.

  13. American Statistical Association. Committee on privacy and confidentiality. Comparison of HIPAA Privacy Rule and The Common Rule for the Protection of Human Subjects in Research. 2011.

    Google Scholar 

  14. Sanchez-Pinto LN, Mosa ASM, Fultz-Hollis K, Tachinardi U, Barnett WK, Embi PJ. The emerging role of the chief research informatics officer in academic health centers. Appl Clin Informat. 2017;8(3):845–53.

    Article  Google Scholar 

  15. Brown JS, Holmes JH, Shah K, et al. Distributed health data networks: a practical and preferred approach to multi-institutional evaluations of comparative effectiveness, safety, and quality of care. Med Care. 2010;48(6., Supplement 1: Comparative Effectiveness Research: Emerging Methods and Policy Applications):S45–51.

    Article  Google Scholar 

  16. Holmes JH, Elliott TE, Brown JS, et al. Clinical research data warehouse governance for distributed research networks in the USA: a systematic review of the literature. JAMIA. 2014;21:730–6.

    PubMed  Google Scholar 

  17. Maro JC, Platt R, Holmes JH, et al. Design of a national distributed health data network. Ann Intern Med. 2009;151:341–4.

    Article  Google Scholar 

Download references

Acknowledgments

In addition to the members of the AMIA CRI-WG, I must acknowledge a number of sources. 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 [13]. The section on roles owes a great deal to the paper by Sanchez Pinto et al. [14] 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 [14,15,17] was also influential. The implementation section benefited from Adam Tobias and colleagues’ work at USF [11]. Of course, none of these authors bears any responsibility for errors or misunderstandings that may have crept into this chapter.

Author information

Authors and Affiliations

  1. Department of Family Medicine, NorthShore University HealthSystem, Research Institute, 1001 University Place, Evanston, IL, USA

    Anthony Solomonides PhD, MSc (Math), MSc (AI), FAMIA

Authors
  1. Anthony Solomonides PhD, MSc (Math), MSc (AI), FAMIA
    View author publications

    You can also search for this author in PubMed Google Scholar

Editor information

Editors and Affiliations

  1. Duke University School of Nursing, Durham, NC, USA

    Rachel L. Richesson

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

    James E. Andrews

Rights and permissions

Reprints and permissions

Copyright information

© 2019 Springer International Publishing

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Solomonides, A. (2019). Research Data Governance, Roles, and Infrastructure. In: Richesson, R., Andrews, J. (eds) Clinical Research Informatics. Health Informatics. Springer, Cham. https://doi.org/10.1007/978-3-319-98779-8_14

Download citation

  • DOI: https://doi.org/10.1007/978-3-319-98779-8_14

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-98778-1

  • Online ISBN: 978-3-319-98779-8

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics

Search

Navigation