WEDNESDAY, Sept. 19 (HealthDay News) -- Most medical school institutional review boards (IRBs) don't treat individual case reports as "research," as it's defined by the United States Government Code of Federal Regulations, according to a research letter published in the Sept. 19 issue of the Journal of the American Medical Association.
Mukta Panda, M.D., of the University of Tennessee College of Medicine in Chattanooga, and colleagues surveyed 124 medical schools in the continental United States. They elicited information -- in most cases from IRB officers -- about whether a single case report requires IRB approval before publication or presentation, and if so, whether the institution considers a case report to be "research," whether the IRB functions as a privacy board, and whether it requires a review due to research requirements or privacy rules.
Based on data from 116 schools, the researchers found that most (78 percent) did not require IRB approval for a case report. Of the schools that did require approval, 40 percent of the boards served only as IRBs, and the rest functioned as an IRB and privacy board. Twenty-four percent conducted reviews because they considered case reports to be research, 32 percent due to privacy issues, and 44 percent for both reasons.
This study "indicates that, de facto, most medical school IRBs do not consider a single case report to represent research under the federal definition," the authors write. "Further research should consider what it is that needs protection in a case report, and who is responsible for overseeing that protection: the authors, the IRB of the authors' institution, or the publishing journal."
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