Trial Design
Regulatory and ethical considerations for linking clinical and administrative databases

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Clinical data registries are valuable tools that support evidence development, performance assessment, comparative effectiveness studies, and the adoption of new treatments into routine clinical practice. Although these registries do not have important information on long-term therapies or clinical events, administrative claims databases offer a potentially valuable complement. This article focuses on the regulatory and ethical considerations that arise from the use of registry data for research, including linkage of clinical and administrative data sets. (1) Are such activities primarily designed for quality assessment and improvement, research, or both, as this determines the appropriate ethical and regulatory standards? (2) Does the submission of data to a central registry, which may subsequently be linked to other data sources, require review by the institutional review board (IRB) of each participating organization? (3) What levels and mechanisms of IRB oversight are appropriate for the existence of a linked central data repository and the specific studies that may subsequently be developed using it? (4) Under what circumstances are waivers of informed consent and Health Insurance Portability and Accountability Act authorization required? (5) What are the requirements for a limited data set that would qualify a research activity as not involving human subjects and thus not subject to further IRB review? The approaches outlined in this article represent a local interpretation of the regulations in the context of several clinical data registry projects and focuses on a specific case study of the Society of Thoracic Surgeons National Database.

Section snippets

Fundamental uses of a clinical registry: quality improvement and research activities

Registry information can be collected for both QI activities and research, and the boundary between these 2 types of activity can be indistinct.6, 7, 8, 9 The interplay between research and QI activities is particularly complex for clinical registries because they often serve both functions simultaneously.

The relevant federal regulations that must be considered include (1) the Privacy and Security Rules (45 CFR §160 and 164; referred to herein as “the Privacy Rule”), which specifically address

Regulatory requirements—Common Rule and Privacy Rule

The QI and research definitions outlined above, as well as the specific context or set of activities in which they fall, help to determine which ethical and regulatory standards are applicable. An IRB is a committee that has been formally designated to review, approve, and monitor biomedical and behavioral research involving humans. The Office for Human Research Protections (OHRP) of the US Department of Health and Human Services helps ensure that research that is conducted, supported, or

Case study

The following example illustrates the application of these regulatory issues to a real-world example of use of a linked clinical-claims hybrid database derived from the STS NDB and national Medicare claims data. This demonstrates how local interpretation of the Common and Privacy Rule led to a strategy for the creation and use of this linked data registry that we believe is consistent with these ethical and regulatory standards.

The STS NDB also exemplifies a dual-use registry. The STS NDB was

Conclusions and future directions

This article outlines the ethical issues and regulatory considerations involved with the linking and analysis of clinical registry data. Also defined in this article is our rationale for why research using these data does not necessarily require patient informed consent or authorization, even if direct patient identifiers are collected. An important assumption of the case study included in this article involving the DUHS IRB and the STS National Database is that extensive efforts are made to

Disclosures

This work was supported by funding from the Society of Thoracic Surgeons, the Agency for Healthcare Research and Quality for the Duke University Medical Center CERTs (Centers for Education & Research on Therapeutics), and funding from the American Heart Association (AHA) for the Duke University School of Medicine AHA Pharmaceutical Roundtable Outcomes Research Centers.

Please note that the contents of this article were finalized prior to the enactment of the American Recovery and Reinvestment

Acknowledgements

We would like to acknowledge Cynthia M. Shewan for her thoughtful insights and tireless facilitation of review by all of the necessary parties.

References (29)

  • JacobsJ.P. et al.

    The rationale for incorporation of HIPAA compliant unique patient, surgeon, and hospital identifier fields in the STS database

    Ann Thorac Surg

    (2008)
  • PetersonE.

    Research methods to speed the development of better evidence—the registries example

  • Website of the American College of Cardiology National Cardiovascular Data Registry (ACC NCDR) [Internet]. American College of Cardiology

  • Website of the Society of Thoracic Surgeons National Database [Internet]. Society of Thoracic Surgeons

  • Website of the America Heart Association Get With The Guidelines (AHA GWTG) [Internet]. American Heart Association

  • TuJ.V. et al.

    Impracticability of informed consent in the Registry of the Canadian Stroke Network

    N Engl J Med

    (2004)
  • CasarettD. et al.

    Determining when quality improvement initiatives should be considered research - Proposed criteria and potential implications

    JAMA

    (2000)
  • LynnJ. et al.

    The ethics of using quality improvement methods in health care

    Ann Intern Med

    (2007)
  • DavidoffF. et al.

    Publication Guidelines for improvement studies in health care: evolution of the SQUIRE Project

    Ann Intern Med

    (2008)
  • Website of SQUIRE guidelines for quality improvement reporting [Internet]. Multiple publishers

  • Code of Federal Regulations (CFR): PART 160—GENERAL ADMINISTRATIVE REQUIREMENTS [Internet]. National Archives and Records Administration

  • Code of Federal Regulations (CFR): PART 164—SECURITY AND PRIVACY [Internet]. National Archives and Records Administration

  • Code of Federal Regulations (CFR): PART 46–PROTECTION OF HUMAN SUBJECTS [Internet]. National Archives and Records Administration

  • CaliffR.M. et al.

    Health Insurance Portability and Accountability Act (HIPAA)—must there be a trade-off between privacy and quality of health care, or can we advance both?

    Circulation

    (2003)
  • Cited by (0)

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