Compliance Tip: Research Consent in Electronic Health Record

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Medical Record Requirements

Clinical Research Informed Consent and HIPAA Authorization

Are you uploading your research consent forms into Epic?
UCI Health medical records must include fully executed research consents and accompanying HIPAA Research Authorization, except in limited circumstances (e.g. a Certificate of Confidentiality has been issued, etc.)

When is it required?
In general, the research consent must be uploaded to Epic:

  • When the consent is related to clinical care or treatment of a patient (e.g. use of a drug, device, biologic, surgery, psychotherapy, or other treatment, etc.).

In general, the HIPAA Research Authorization must be uploaded to Epic:

  • Regardless of the research activity type.

How do you do it?
To ensure consents and authorizations are uploaded into Epic:

  • Email a copy of the signed and fully executed documents to the Health Information Management inbox . The HIM team will upload the documents to the patient’s medical record within 24 hours.
  • Include a patient label or 2 identifiers (e.g. patient’s first/last name and MRN) on the first page of each document.
  • For non-English consents, please attach the English version with the non-English version.

For more information, please see:

If you have any questions, please contact Jinah Chang, Research Compliance Principal Analyst, by phone at 714-456-3677 or email .

Thank you,

Valerie M. Dixon, MBA, CCEP, CHC, CPHQ
Interim Chief Compliance & Privacy Officer

Beverly L. Alger, MD, CHRC, CCRP
Director, Clinical Research Operations
UC Irvine Center for Clinical Research (UCI-CCR) 

© 2019 The Regents of the University of California. All rights reserved. Proprietary and Confidential. For Internal Distribution Only.

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