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102.3 Organization Policy on Single Case Reports and Case Series

August 2013

It is the policy of the Organization that a “single” case report (three or fewer cases) does not require review by the JHM IRB.  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 cases) meets the definition of human subjects research and requires the submission of a new protocol application in eIRB. 

NOTE: Case reports for publication must be prepared in accordance with the requirements of the HIPAA privacy regulations. Any use or disclosure of PHI must be authorized by the patient, or, if the patient is deceased, the patient’s family. Publication of a case report containing PHI is a disclosure of PHI. The Privacy Officer or designated HIPAA authority at the applicable location within the Organization should be consulted prior to submission of the case report to assure proper authorization was obtained. 

For guidance please see:

Case Report Publication Guidance: IRB Review and HIPAA Compliance

Guidance for Investigators HIPAA Requirements for Case Reports


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