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Case Reports

DEFINITION

Case Report

PROCESS

If an activity meets the definition of a Case Report, UCI faculty/resident should complete a Request for Determination of Non-Human Subjects Research form and submit to the IRB.

  • Journals and science conference venues will generally inquire if an IRB review occurred for the Case Report activity
  • UCI faculty/resident should retain the IRB-signed Request for Determination of Non-Human Subjects Research form (indefinitely) in the event that a journal (or, a Public Request Act/PRA, or external audit) request occurs

A HIPAA Authorization from the subject(s) of the Case Report is not required if there is access to PHI however there is no disclosure of PHI (outside of the covered/hybrid entity) in the Case Report publication.

A HIPAA Authorization from the subject(s) of the Case Report is required if there is disclosure of PHI outside of the covered/hybrid entity in the Case Report publication.  (Disclosure of photos, even if de-identified, would require an Authorization Form.)

Use this Authorization Form:

  • Section “Release Records To”:  indicate the UCI faculty/resident name, and include the caveat “to be further disclosed in a Case Report publication”
  • Section “Purpose”indicate “Case Report publication”

The signed Authorization Form should be uploaded and maintained in the patient's record.  At the time of signing the Authorization Form, the patient has the right to ask for a copy of the signed Authorization Form.

Translated Authorization Forms are located here:  http://www.ucihealth.org/patients-visitors/medical-records 

A list of PHI data elements:   https://research.uci.edu/compliance/human-research-protections/researchers/protected-health-information-hipaa.html#phi

DEATH DATA AND RECORDS

If the Case Report involves access, use, and disclosure of data from death records, the above described process would be similar (i.e., Request for Determination of Non-Human Subjects Research Form, Authorization Form).

For death data/records accessed through the UCI Medical Center:

  • If there is no disclosure of PHI in the Case Report publication, a HIPAA Authorization is not required.
  • A HIPAA Authorization Form from the legally authorized representative of the deceased patient is required if there is disclosure of PHI outside of the covered/hybrid entity in the Case Report publication.  (Follow the above "PROCESS")

For death data/records accessed publicly through CDPH:

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