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To the Editor: The role of case reports in generating medical knowledge is debated.¹ The US Government Code of Federal Regulations (CFR) requires all human subjects' research be reviewed by institutional review boards (IRBs). It defines research as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" but does not specifically address case reports.² Therefore, each IRB implicitly defines the research status of case reports by whether such studies require its approval. In addition, some IRBs function as privacy boards to meet requirements of the Health Insurance Portability and Accountability Act (HIPAA); they may also review case reports in this capacity.³ We therefore assessed whether medical school IRBs require review of case reports; if so, whether they do so because they consider a single case report as research under the federal definition or to meet privacy requirements.

Methods

We surveyed the 124 continental . . . [Full Text of this Article]

Mukta Panda, MD
mukta.panda@erlanger.org

Gregory W. Heath, DHSc, MPH; Norman A. Desbiens, MD; Benjamin Moffitt, BA
Department of Medicine
University of Tennessee College of Medicine
Chattanooga

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