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

investigator must commit to attempting to contact within the
therapeutic window, the subject's family member (who may not be
a legally authorized representative) and asking whether he or
she objects to the subject's participation in the research.
The investigator's efforts to make this contact must be
summarized and made available to the IRB at the time of
continuing review. -
The IRB also is responsible for ensuring that procedures are in
place to inform each subject, legally authorized
representative, or family member at the earliest feasible
opportunity of the subject's inclusion in the research, the
details of the research and other information contained in the
consent document, and that they may discontinue further
participation of the subject at any time without penalty or
loss of benefits to which the subject is otherwise entitled.
These policies establish narrow limits for allowing research
without informed consent in certain studies of emergency
medical interventions, and harmonize these standards throughout
HHS. We believe HHS's new overall approach to emergency
research situations may offer the best hope, in an ethical
manner, to critically ill, unconscious persons who have no
readily available legal representative to give consent and who
cannot be successfully treated through conventional means, but
might benefit from a promising experimental intervention.

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