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Informed Consent - Exception for Emergency Research. Briefly: What are the regulatory requirements?Focus: Community consultation requirements.What you can doWhat we can do . Important Note. FDA regulations do not allow IRB waiver of the consent requirement or altering of the consent procedure.FDA regulations provide an exception to informed consent forindividuals in a life-threatening situation (21 CFR 50.23)emergency research (21 CFR 50.24).

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