Statement by Mary K. Pendergast, Deputy Commissioner, Senior Advisor to the Commissioner, Food and Drug Administration, Department of Health and Human Services

Pharmaceuticals for Human Use (ICH). This guidance, while not
a regulation, defines what is good clinical practice and
provides a unified international standard for designing,
conducting, recording, and reporting trials that involve the
participation of human subjects.
V. LIMITED EXCEPTIONS TO THE INFORMED CONSENT REQUIREMENTS
Having discussed the system for human subject protection, it is
important to recognize that there are limited circumstances
when informed consent is not obtained from a human subject or
his or her representative. There are three "exceptions" to
FDA's informed consent requirements. These exceptions are:
1) for a physician to preserve the life of an individual
patient; 2) for the conduct of a narrow class of research in
emergency settings; and 3) for use by the Department of Defense
(DoD) of specific investigational products in combat
exigencies.
The FD&C Act specifically requires that investigators inform
subjects receiving drugs under an IND that the drugs (and
biologics) are investigational and "obtain the consent of such
human beings or their representatives, except where they deem
it not feasible, or in their professional judgement, contrary
to the best interests of such human beings" (Section 505 and
520). The Medical Device Amendments of 1976 provided that the
sponsor of clinical investigations must "assure that informed

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