Waiver of Informed Consent

Waive or alter some or all of the eight required elements of consent in accordance with federal regulations

UW-Madison's IRBs may waive or alter some or all of the eight required elements of consent for some minimal risk research in accordance with federal regulations (45 CFR 46.116) and FDA guidance.

The Common Rule and FDA guidance authorizes UW-Madison's IRBs to waive or alter the informed consent requirements in either of the following circumstances:

  1. In research activities designed to study certain aspects of public benefit or service programs; or
  2. If the IRB finds and documents all of the following criteria are met:
    1. the research involves no more than minimal risk to the subjects;
    2. the waiver or alteration will not adversely affect the rights and welfare of the subjects;
    3. the research could not practicably be carried out without the waiver or alteration; and
    4. whenever appropriate, the subjects will be provided with additional information after participation.



Keywords:waive ICF   Doc ID:41962
Owner:Monica E.Group:Health Sciences IRBs
Created:2014-07-17 14:52 CDTUpdated:2018-05-11 16:14 CDT
Sites:Health Sciences IRBs
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