Do case reports or case studies require IRB review?
A5: Yes. If a case report is deemed to be no-greater-than-minimal risk, it generally falls under an “exempt” category. However, there have been case reports that contain “sensitive” content and therefore would be reviewed either under the “expedited” or “full” review procedures. The determination of whether a case report meets the exempt criteria is made by the IRB. If a case report is determined to be “exempt,” the investigator does not have to follow the procedures for continuing annual review.
