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102.3 Organization Policy on Single Case Reports and Case Series

May 2021

It is the policy of the Organization that a single case report or case series (three or fewer cases) does not constitute human subjects research requiring review and approval by the JHM IRB. If an investigator wishes to have the project formally assessed by the JHM IRB to see if it meets the Organization’s definition of a single case report or case series, the investigator must submit a new protocol application in the eIRB system, requesting a Not Human Subjects Research review. If the project qualifies, the JHM IRB will send an acknowledgment letter to the investigator stating:

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

Investigators should inform the Office of Human Subjects Research if a journal does not accept the IRB’s decision by contacting the IRB Help Desk at jhmeirb@jhmi.edu.

NOTE: Case reports/series 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/series to ensure proper authorization was obtained if necessary.

For guidance please see:

Case Report Publication Guidance: IRB Review and HIPAA Compliance

Guidance for Investigators HIPAA Requirements for Case Reports