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Research Letter
September 19, 2007

Research Status of Case Reports for Medical School Institutional Review Boards

Author Affiliations

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2007;298(11):1277-1278. doi:10.1001/jama.298.11.1277

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.