If your study requires waivers or alterations of HIPAA authorization, those will be reviewed and granted by the HIPAA privacy board that has been designated for the study. During the reliance process, RELIANT will work with the external IRB to determine which institution (UW or the external IRB) will be making such determinations – in most cases, the IRB of Record will make the determinations.

NOTE: for cedes to WCG or Advarra, HIPAA determinations will ALWAYS be made by the external IRB.

ARROW’s cede application asks questions to determine if HIPAA applies to the study, and if HIPAA applies, asks questions regarding how authorization will be obtained and if any waivers or alterations of authorization are needed. If waivers or alterations are needed, you will be asked to provide the information needed to justify those determinations. If the reliance arrangement requires UW to grant the waivers or alterations, reliance staff will use the information provided to grant them (see HRP 441 – CHECKLIST – HIPAA Waiver of Authorization for the criteria that are to make HIPAA determinations). If the external IRB is responsible for granting waivers or alterations, the questions should be answered so the study team is aware of the waivers or alterations needed to conduct the study and will have considered the information will needed to request of the external IRB.

Please note that when an external IRB is acting as the HIPAA privacy board, it is not responsible for reviewing authorization forms (unless combined with the consent form) and this remains an institutional responsibility. If your study requires use of a standalone authorization form, RELIANT will review that form to ensure the required elements are included during its review of your cede request. For more information, see HRP 834-WORKSHEET-Institutional Requirement for Ceded Studies and HRP-502c -TEMPLATE- Institutional Consent Language.