Under 45 CFR 46.116(f), an IRB may waive consent only if the research is minimal risk, the waiver will not adversely affect subjects' rights and welfare, the research could not practicably be carried out without the waiver, and (when appropriate) subjects will be provided pertinent information afterward.
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Glossary Term
Waiver of Informed Consent
Participant Protections
Also known as: consent waiver, waiver of consent
An IRB determination that informed consent is not required for the research because all four regulatory criteria are met.
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