Consult guidance from Michigan Medicine Corporate Compliance Office (level-2 login or VPN required) and IRBMED for general definitions (PHI, HIPAA, Covered Entity, etc.) and concepts.
The vast majority of studies subject to IRBMED oversight involve access to Michigan Medicine Protected Health Information (PHI). The study team members listed in an IRB application (Section 01) may fall into one of the following categories:
If you have questions about a member status related to CE, contact the U-M Compliance Office. U-M faculty/staff/students/trainees outside the CE do not typically view/access PHI as part of their current appointment/affiliation with U-M.
This document provides guidance on how to complete the IRB application (especially Section 25 HIPAA and sub-sections), for study team members who are within the U-M but outside the CE. This guidance does not apply to study team members within the CE, nor to external study team members or disclosing PHI to external entities.