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

this waiver must be submitted to FDA as a separate and clearly
identified investigational device exemption (IDE) application
or investigational new drug (IND) application. This will
permit the Agency to very carefully review each of these
studies to help ensure that they meet the narrow criteria of
the rule before the study is allowed to proceed. The IRB and a
physician free of conflict-of-interest must ensure each of the
following for these emergency research activities to proceed:
* The human subjects are in a life-threatening situation;
* Available treatments are unproven or unsatisfactory; and
* Research is necessary to determine the safety and
effectiveness of the particular intervention.
* It is not feasible to obtain informed consent from the
subjects as a result of their medical condition or from
the subjects' legally authorized representative because
the intervention must be administered before they could
feasibly be reached, and there is no reasonable way to
identify prospectively the individuals likely to become
eligible for participation in the research.
* Participation in the research holds out the prospect of
direct benefit to the subjects because: the lifethreatening situation necessitates intervention;
information from appropriate preclinical (animal) studies
and related evidence support the potential for the
intervention to be beneficial; and the risks associated
with the research are reasonable in light of what is known

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