5.2 Waiver or Alteration of Informed Consent and HIPAA Authorization

Last Revised: 2/7/2024

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for granting a waiver or alteration of informed consent with or without waiver of HIPAA authorization in research.


2.0 Policy

It is the policy of the Organization that:


3.0 Criteria for Waiver or Alteration of Consent under HHS regulations and HIPAA regulations


4.0 Criteria for Waiver of Parental/Guardian Consent (Permission) under HHS regulations at 45 CFR 46.408(c)


5.0. Criteria for Waiver or Alteration of Consent in research involving public benefit and service programs conducted by or subject to the approval of state or local officials


6.0. Criteria for Waiver or Alteration of Consent for FDA Regulated Minimal Risk Research


7.0. Responsibilities of IRB/ORA


DOCUMENT HISTORY:  Written: 1/11/2016 (Approved: 1/11/2016) - original author not recorded

 Revised: 1/29/2018 - revision not documented

 Revised: 3/17/2023 – stylistic revisions

 Revised: 2/7/2024 – sections 2.4 and 6 revised to allow for waiver or alteration of consent for FDA regulated research as per revised 21 CFR 50.22 (final rule January 22, 2024).


Revision #14
Created 24 October 2019 21:39:26 by Autumn M Eberly
Updated 17 April 2025 16:03:10 by Robert A Lewis