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

scientifically sound, select qualified researchers, provide
them with the information they need to properly conduct the
research study, and ensure proper monitoring of the study. The
second layer of protection is provided by the researcher, whose
professional and civic obligation is to conduct ethical
research and make sure that the study participants are apprised
of, and fully understand, the potential risks and benefits of
the research. The third layer of protection is provided by
IRBs. It is the responsibility of the IRBs to develop and
follow procedures for initial and continuing review of the
integrity of the research and the protection of the rights and
welfare of its human subjects. The last layer of protection is
provided by FDA, which regulates the organization and
procedures of IRBs, researchers, research sponsors, and others
involved in clinical trials. These layers of protections are
applied to each clinical study to ensure the integrity of the
data and in order to protect the rights and welfare of the
human subjects of clinical research.
We take very seriously our obligation to protect the rights and
welfare of all research subjects who participate in research
involving FDA-regulated products. We believe that our
regulations and inspection programs are important to help
ensure that human research subjects are protected at the same
time that vital information on the safety and effectiveness of
drugs, biologics, antibiotics, and devices is gathered.

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