Case Reports

A case report is a retrospective analysis of one, two, or three clinical cases. 

The main intent of publishing a case report is to gather information to be shared for clinical education purposes and do not qualify as “research” in the strict sense. As such, case reports do not require IRB review. 

However, if more than three clinical cases are involved, the activity may constitute “research” under the Federal Policy for the Protection of Human Subjects (45 CFR 46.102(d)) and would require IRB review. The UF IRB will make the call as to whether a case report (or any activity) qualifies as research. 

IRB Approval 

In the event that a journal requires a written acknowledgment from an IRB to publish a case report, the author may approach the IRB for guidance. 

An IRB paper about case reports is available.

Journal Requirements for Consent 

Please be aware the many journals require authors to obtain “consent” from persons described in a case report, even when a report or a photograph contained in a report does not directly identify an individual.  UF can not dictate what journals require, so you may wish to check with journals prior to submitting a case report to learn what their requirements are. 

Reminders 

Please be mindful of the following: 

• Authors should be sensitive to unique or unusual diagnoses or illnesses, which when combined with the hospital name, clinic, or state residence, may identify a subject.
• Case Reports containing a unique intervention, disorder, familial condition, unique family trees, or pedigrees should be masked or disguised when such information could identify an individual or their family members. If the information can not be masked, written authorization is required.
• Photographs or other images that may identify an individual should be appropriately masked to prevent identification.
• Please remember, de-identified or anonymized patient information does not require patient authorization.