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

FDA received 90 comments in response to the proposed rule. The
vast majority of these comments supported the proposal,
although frequently the comments contained suggestions or
requests for clarification. Of the 16 comments opposed to the
proposed rule, the majority were from individuals who concluded
that informed consent should not be waived under any
circumstances. The comments were addressed in the preamble to
the final rule published in October 1996.
The final rule provides access to potentially promising
experimental treatments to patients in life-threatening
situations. This rule sets forth special protections to human
subjects who may benefit from this research, but who are not
able to give consent on their own, and for whom a family member
or legally authorized representative is not available to either
withhold or give consent on the subject's behalf. Clearly, any
researcher who can obtain informed consent must do so.
Frequently, there are ways to design a study so that one is not
confronted with emergency situations in which consent cannot be
obtained. But in some cases, a subject cannot give his or her
informed consent, for example, when there is a life-threatening
emergency and there is no one available who is authorized to
consent to an experimental treatment that might save that
person's life. In that case, the Belmont Report directs us to

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