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.

Adopted By: All Campus IRB
Adoption Date: November 10, 2005

Policy

  1. 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.

  2. UW-Madison IRBs may waive the requirement to obtained 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.





Keywords:emergency use planned consent waive exceptions   Doc ID:29562
Owner:Ryan M.Group:VCRGE and Graduate School
Created:2013-04-18 12:06 CDTUpdated:2015-10-27 14:03 CDT
Sites:VCRGE and Graduate School
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