May 2010

It is the policy of the Organization that a “single” case report (three or fewer cases) will not be reviewed by the JHM IRB.  Investigators do not need to submit a JHM IRB form. If an investigator wishes to have the project assessed by the JHM IRB to see if it meets the Organization’s definition of a single case report, the investigator should contact the JHM IRB.  If the project qualifies as a single case report, the JHM IRB will send to the investigator a form letter that states:

“The IRB received your request (dated ‘x’), concerning a single case report you wish to publish.  The JHM IRBs have determined that a case report does not produce generalizable knowledge, nor is it an investigation of an FDA regulated product.  IRB review is not required for this activity.”

Investigators should inform the IRB if a journal does not accept the IRB’s decision.  The issue will then be brought to an IRB Chairs Meeting for resolution.

A case series (more than 3) meets the definition of research.

NOTE: Case reports for publication must be prepared in accord with the requirements of the HIPAA privacy regulations. Any use or disclosure of PHI must be done with authorization of the patient, or, if the patient is deceased, authorization of the patients family. Publication of a case report is a disclosure of PHI. The HIPAA Privacy Office should be consulted prior to submission of the case report to assure proper authorization was obtained.