What if I plan to conduct research at UCF Health? Do I have to submit to both UCF IRB and the HIPAA Privacy Officer for UCF Health?
The IRB office and the HIPAA Privacy Officer for UCF Health have important, but separate, roles to play before human subjects research -- which may include interactions with patients and/or access to and use of their personal medical records -- can be conducted at UCF Health.
The PI must obtain approval from both the UCF IRB and the UCF Health Privacy Officer (as applicable) and is responsible for ensuring that appropriate documentation is uploaded to the study in iRIS and provided to UCF Health.
The PI must submit the IRB protocol, Informed Consent, and other study materials in iRIS. The UCF IRB will inform the PI whether HIPAA Privacy Officer review is required and will provide the PI with the UCF Health HIPAA Authorization form and/or the UCF Health Review Preparatory to Research form, as applicable.
The PI will submit the completed UCF Health HIPAA Authorization form and the approved IRB Protocol to the HIPAA Privacy Officer for UCF Health for review and approval. If the study involves review of medical records to identify potential research subjects or to develop a research protocol, then a completed UCF Health Review Preparatory to Research form must be submitted to the HIPAA Privacy Officer first.
When the UCF Health HIPAA Authorization form and/or the UCF Health Review Preparatory to Research form are approved, the PI must upload the document(s) to the IRB approved study in iRIS for documentation purposes only, using the IRB Miscellaneous Attachment Form
The study (including recruitment of study participants and/or review of their personal medical records) can begin only when the PI has obtained an IRB approval letter and approval from the HIPAA Privacy Officer for UCF Health.
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