Trial DesignRegulatory and ethical considerations for linking clinical and administrative databases
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.
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