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

legally effective consent from; the subject (for
example, if the subject is unconscious). In contrast,
a subject's inability to speak a particular language
is not considered an inability to communicate.
3. Time is not sufficient to obtain consent from the
subject's legal representative.
4. No alternative method of approved or generally
recognized therapy provides an equal or greater
likelihood of saving the subject's life.
The first three requirements are contained in the Medical
Device Amendments. The fourth requirement was added by FDA to
prevent routine reliance on the exception.
The regulatory requirement for this exception "applies to
individual situations and not to categories of studies as a
whole" (46 FR 8945, January 27, 1981), and suggests that there
should be great confidence in the effectiveness of product,
i.e., the situation must "necessitate" use of the product.
B. Conduct of Research in Emergency Settings
Because the section 50.23 exception was not formulated to apply
to clinical trials, in October 1996 FDA promulgated a limited
exception to the informed consent requirement to permit the
conduct of a narrow class of research involving subjects in

life-threatening situations (21 CFR 50.24). These regulations

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