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

In general, FDA also accepts foreign safety and efficacy
studies that were not conducted under an IND or IDE provided
that they are well designed, well conducted, performed by
qualified investigators, and conducted in accordance with
ethical principles acceptable to the world community. We
recognize that standards for protection of human subjects vary
from country to country. If FDA, however, is to accept the
data, the conduct of these studies must meet at least minimum
standards for assuring human subject protection. Therefore,
for studies submitted to FDA which were conducted outside the
United States (and not under an IND or IDE), the Agency
requires demonstration that such studies conformed with the
ethical principles outlined in the Declaration of Helsinki or
with the laws and regulations of the country in which the
research is conducted, whichever provides greater protection of
the human subjects.
Thus, as is evident from the foregoing discussion, there are
many different entities which must be involved in the
protection of human subjects. FDA works hard to make certain
that all of the entities understand their roles and
responsibilities and that they live up to the expectations
placed on them. The protection of the people of this country
who are willing to participate in medical research demands no
less.

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