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Exceptions to Informed Consent Requirements in Emergency Situations
The document describes when the UW-Madison IRBs make exceptions to the informed consent requirements in emergency situations.
- UW-Madison IRBs may allow exceptions to the informed consent requirements for emergency use of test articles in conformance with FDA regulations and guidance [21 CFR 50.23]. See, Emergency Use of Test Articles Policy.
- UW-Madison IRBs may waive the requirement to obtain informed consent for planned emergency research in conformance with the federal Common Rule [45 CFR 46] and FDA regulations [21 CFR 50.24] and guidance. See, OHRP Emergency Research Informed Consent Requirements; FDA IRB Information Sheets - Updated 9/98.
Adopted By: All Campus IRB
Adoption Date: November 10, 2005
Revised By: Cross-Campus HRPP Advisory Committee
Revision Date: November 7, 2019
Copyright © 2006 University of Wisconsin System Board of Regents