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Human Subjects Division (HSD)


Requests for Waivers of Consent or HIPAA Authorization

Nov 3, 2009 at 8:35am

Background.  One common issue in "back and forth" communications between researchers and the IRB is the IRB's need for information that justifies a researcher's request for a waiver of consent, waiver of documentation of consent, and/or waiver of HIPAA authorization.   The IRB is required to establish and document that the federally-mandated criteria for granting these waivers have been met.

New requirement.  Effectively immediately, the basic IRB application (form 13-11) now asks researchers to attach a new form that addresses these criteria.  These forms are entitled Waiver Request: Consent and Waiver Request: HIPAA Authorization.  The goal of creating these new forms is to reduce some  "back and forth" communication and to provide a consistent method of documenting the waivers that complies with federal regulatory requirements.

Why create new forms?  Why not just add questions to the existing application?   Many researchers do not need a waiver of consent or HIPAA authorization, and adding these questions to the existing application form would lengthen the form by several pages.