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

non-scientific areas, and one member who is not otherwise
affiliated with the institution (one person may fulfill
multiple roles). No IRB may have a member participate in the
IRB's initial or continuing review of any project in which the
member has a conflicting interest, except to provide
information requested by the IRB.
The IRB is required to conduct continuing review of ongoing
research at intervals appropriate to the degree of risk, but
not less than once per year. It also has the authority to
observe or have a third party observe the consent process and
the research. IRBs are not required to register with FDA nor
inform FDA when they begin reviewing studies.
III. HUMAN SUBJECT PROTECTION ACTIVITIES
FDA, which monitors the activities of research sponsors,
researchers, IRBs and others involved in the trial, provides an
additional layer of protection. We take no human right more
seriously than the protection of people enrolled in clinical
trials.
A. FDA's Bioresearch Monitoring Program
In order to protect the rights and welfare of human research
subjects and to verify the quality and integrity of data
submitted to FDA in support of marketing applications, FDA
monitors all aspects of FDA-regulated research through a

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