REQUEST FOR WAIVER OF HIPAA AUTHORIZATION

A Principal Investigator may request a Waiver of HIPAA Authorization for the use and/or disclosure of Protected Health Information (PHI) for either:

• Regulated research projects when simultaneously requesting a Waiver of Informed Consent or a Waiver of Documentation of Informed Consent.
• Projects that are not otherwise subject to IRBMED oversight because they are either:
• Exempt under OHRP or FDA regulations, but study team members will be accessing PHI.
• Not-Regulated under OHRP or FDA regulations, but study team members will be accessing PHI

Projects that are considered to be Not-Regulated under OHRP or FDA regulations include (but are not limited to) the following:

• Investigator certifications for reviews of PHI preparatory to research submitted in the eResearch application.
• Investigator certifications for research involving decedents’ information submitted in the eResearch application.
• In consultation with other units (e.g., the UMHS Privacy Office and DRDA), any use or disclosure of limited data sets under data use agreements.
• Databases.
• Case studies.