Research Exempt from Informed Consent
If the IRB determines that the research is exempt from IRB review, the research may not require a consent form. If, however, the research involves contact with a subject Waiver of Documentation of Consent may be appropriate.
In addition, if the research involves protected health information, the researcher must seek each subject's HIPAA authorization or obtain an IRB Waiver of Authorization, even if the research itself is exempt from IRB review.
The study does not include the collection of health information with identifiers however during the conduct of this study someone from outside of UVa will have access to PHI while observing patients or healthcare providers who are administering care. Patients must sign the UVA Health System HIPAA Authorization Form prior to the research observation taking place. The MTA must include the required language for a HIPAA Data Use Agreement.