The UW-Madison IRB serves as the institution’s HIPAA privacy board. This means the IRB is responsible for reviewing and granting requests for waivers or alterations of HIPAA authorization. When ceding IRB review, we will also cede privacy board review when the reviewing IRB agrees to assume that responsibility. In some cases, however, the reviewing IRB will not agree to serve as the privacy board and UW-Madison is then required to retain that responsibility. If this occurs and your study requires a HIPAA waiver, you will need to provide additional information with your cede application to ensure we can provide appropriate privacy board review. RELIANT will advise you when this is required and when you will need to complete HRP-810-FORM-Applications for HIPAA Waiver for Ceded Studies. If required, the completed form should be uploaded in the supplemental information page of the cede application.

Please note that when the 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 an 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. For criteria used by the IRB to grant a waiver or alteration of authorization, see HRP 441 – CHECKLIST – HIPAA Waiver of Authorization.