Is IRB approval required for case reports?

Per the College of Medicine's Assistant Dean for Clinical Research, IRB approval is not required for case reports (less than three patients). However, patient protections including following HIPAA privacy and security still apply. Even when working with a resident, medical students should still involve their attending as a mentor and co-author. Generally, while the hospital should not be mentioned anywhere in the manuscript, the hospital should be given some “credit” by way of the attending’s affiliation in the paper’s authorship.

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Answered by Lawrence Mello
last updated: Jul 24, 2023