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

regulations. This regulation allowed the Commissioner of FDA
to determine, upon receipt of an appropriate application from
DoD, that obtaining informed consent from military personnel
for use of a specific investigational drug or biologic would
not be feasible in certain circumstances, and to grant a waiver
from the requirement for obtaining such consent.
The exemption extended, on a case-by-case basis, only to
investigational drugs (including antibiotic and biological
products, including those for protection against chemical and
biological warfare agents) for use in a specific military
operation involving combat or the immediate threat of combat.
A request from DoD for an informed consent waiver must include
the justification for the conclusion (made by physicians
responsible for the medical care of the military personnel
involved) that: 1) the use is required to facilitate the
accomplishment of the military mission; 2) the use would
preserve the health of the individuals and the safety of other
personnel, without regard for any individual's preference for
alternate treatment or no treatment; and, 3) the request
contains documentation to indicate that the protocol has been
reviewed and approved by a duly constituted IRB for the use of
the investigational drug without informed consent.
Each application for waiver from the informed consent
requirements was assessed by the appropriate FDA review

36