5.4 Waiver of Requirement to Obtain Signed Consent Form

1.0 Purpose

The purpose of this policy is to describe the Organization’s process for waiver of the requirement to obtain a signed Informed Consent Form (ICF).


2.0 Policy

It is the policy of the Organization that:


3.0 Criteria for IRB Approval of a Waiver of Requirement to Obtain a Signed ICF


4.0 IRB and/or ORA Responsibilities


DOCUMENT HISTORY:

 Written: 1/12/2016 (Approved: 1/12/2016) - original author not recorded

 Revised: 1/25/2018 - revision not documented

 Revised 12/11/2024 – added (and clarified) types of procedures which might not require written consent outside the research setting (section 3.1.2); added requirement that application describe an appropriate alternative mechanism for documenting that informed consent was obtained under 45 CFR 46.117(c)(1)(iii) (section 3.1.3); minor stylistic changes. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}


Revision #6
Created 24 October 2019 21:39:51 by Autumn M Eberly
Updated 21 March 2025 13:52:00 by Robert A Lewis