A case report is one in which three or fewer records are accessed. Case reports do not meet the definition for human subjects research and do not require oversight by the IRB if the project meets the following criteria (note: An IRB determination of NHSR is required, however):

• Nothing was done to the patient(s) with prior research intent.
• The case report does not contain elements of a systematic investigation (e.g. statistical methods).
• The case report describes an interesting treatment, presentation or outcome.
• The published article will not contain any identifiable information or authorization has been obtained.