5.2 Waiver or Alteration of Informed Consent and HIPAA Authorization

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)

  1. Informing parents or guardians may result in harm to the child. For example, the study involves STD testing of 15-18 year old females which is permitted by state law without parental/guardian permission.

  2. The research is important to the health and well-being of adolescents and the subjects are capable of understanding informed consent at an adult level. For example, the research involves asking 15-18 year old females about their sexual practices, prescribing contraception in accordance with described sexual practices and an annual follow up for three years. The questions are reasonably commensurate with questions asked during gynecologic services which the adolescents are permitted by law to receive without parental permission and the prescribed contraceptive methods are also permitted by state law without parental/guardian permission.

    It should also be noted that the Family Education Rights and Privacy Act (FERPA; 20 U.S.C. §1232g; 34 CFR 99) protects the privacy of personally identifiable information contained within a student’s educational record. FERPA applies to all schools (K-12 and postsecondary institutions) that receive funds under various programs from the U.S. Department of Education. Generally, schools must have written permission from the student (or parent if the student is a minor) in order to release any information from a student’s education record unless it meets some of the specified criteria for which release is allowed.


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 {Approved Russell McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 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). {Approved Russell McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}


Revision #11
Created 24 October 2019 21:39:26 by Autumn M Eberly
Updated 31 July 2024 19:30:52 by Robert A Lewis