Exception From Informed Consent Requirements for Emergency Research

This is a 17 Nov 2014 update from the previous MAPP version dated 4 Feb 2003

This MAPP describes policies and procedures for consistent review and administrative oversight of an investigational new drug application (IND) for emergency research in which the clinical investigation includes a request, pursuant to 21 CFR 50.24, for an exception from the requirement to obtain informed consent from patients.

This MAPP does not apply to emergency treatment of individual patients with investigational drugs without informed consent by physicians carrying out medical care in a life-threatening situation as provided under 21 CFR 50.23 (see also the definition of emergency use at 21 CFR 56.102(d)) or to an emergency situation that does not allow time for submission of an IND as provided under 21 CFR 312.310(d) (i.e., “emergency procedures” for individual patients).

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