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

professional groups and at meetings sponsored by non-profit
organizations where sponsors make up a large proportion of the
audience.
In addition to their inherent value in focusing attention on
the importance of informed consent, FDA's educational efforts
support our enforcement and product approval missions.
Educated researchers who devote appropriate attention to
informed consent and other human subject protections are likely
to conduct studies of high quality in other respects as well.
Such studies are easier for FDA to review and audit, and
approvals can be issued more rapidly. The ultimate beneficiary
is the American public, both those who participate as subjects
in research and those who are treated with the products
approved on the basis of that research.
IV. Interaction Between FDA and Departmental Reaulations
Both FDA and the Department of Health and Human Services (HHS)
have regulations pertaining to the protection of human subjects
(21 Code of Federal Regulation (CFR) Parts 50 and 56 for FDA;
45 CFR Part 46 for HHS). The HHS regulations apply to research
that is conducted or supported by HHS4; FDA's regulations apply
to human subject research involving products regulated by FDA,
whether privately or publicly funded. These FDA-regulated
4The implementation of these regulations is the
responsibility of the National Institutes of Health (NIH).
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