IRB - Case Reports
Case reports are comprised of medical information collected and presented to highlight an interesting medical condition, treatment, presentation or outcome. Although they contribute to generalizable knowledge, they are not considered research because they are not systematic investigations.
In general, the review of medical records for publication of case reports of up to three patients is NOT considered human-subject research and does NOT require IRB review and approval. However, when a larger series of patients is being reported (more than three), there is usually systematic collection of data associated with a specific research question. According to federal regulations, such activity would be considered research and require IRB review and approval. Research that meets this criteria should be submitted to the IRB as chart reviews.
See Chart Review guidance for IRB submission requirements.