Regulatory and ethical considerations for linking clinical and administrative databases

• Published in: The American heart journal Vol. 157; no. 6; pp. 971 - 982
• Main Authors: Dokholyan, Rachel S., Muhlbaier, Lawrence H., Falletta, John M., Jacobs, Jeffrey P., Shahian, David, Haan, Constance K., Peterson, Eric D.
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01.06.2009; Mosby; Elsevier Limited
• Subjects: American Recovery & Reinvestment Act 2009-US; Biological and medical sciences; Biomedical Research - ethics; Cardiology. Vascular system; Cardiovascular; Clinical Trials as Topic - ethics; Clinical Trials as Topic - legislation & jurisprudence; Confidentiality - ethics; Confidentiality - legislation & jurisprudence; Databases as Topic - ethics; Databases as Topic - legislation & jurisprudence; Ethics; Ethics Committees, Research - ethics; Ethics Committees, Research - legislation & jurisprudence; Ethics, Clinical; Ethics, Research; Government Regulation; Health Insurance Portability & Accountability Act 1996-US; Health Insurance Portability and Accountability Act - ethics; Health Insurance Portability and Accountability Act - legislation & jurisprudence; Hospitals; Humans; Informed consent; Informed Consent - ethics; Informed Consent - legislation & jurisprudence; Medical sciences; Patients; Quality Assurance, Health Care; Registries - ethics; Studies; United States; United States; Database; Ethics; Cardiovascular disease; Circulatory system; Cardiology
• ISSN: 0002-8703; 1097-6744; 1097-6744
• DOI: 10.1016/j.ahj.2009.03.023

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.