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

products include, for example, investigational drugs,
biologics, and medical devices. The FDA and HHS regulations
are essentially identical, with differences only where required
to reflect the distinct statutory mandate of the organizations
and the focus of FDA regulations.
The two agencies apply- the regulations in ways fitting their
distinct missions. NIH implements the HHS regulations through
assurances made by the institutions where the research is
conducted. FDA regulates the investigators who conduct the
research and the IRBs which review proposed research studies.
If a research project is conducted or supported by HHS and
involves a product regulated by FDA, both sets of regulations
will apply. In addition, most large research institutions
receiving grant and contract support from HHS have agreed to
review all research involving human subjects conducted at the
institution in accordance with the HHS regulations regardless
of the source of the funding for any particular study. The two
sets of regulations are complementary and together they set
forth criteria that are needed to protect research subjects.
FDA regulates clinical research of investigational drugs,
biologics, antibiotics and medical devices under sections
505(i), 507(d) and 520(g) of the FD&C Act. FDA first imposed
informed consent requirements on January 8, 1963, pursuant to

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