Human Research Protection Program: Policy

Exceptions to Informed Consent Requirements in Emergency Situations

 

Adopted By: All Campus IRB

Adoption Date: November 10, 2005

Purpose:  The document described when the UW-Madison IRBs make exceptions to the informed consent requirements in emergency situations.

Policy

I.      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.

II.     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.