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

IRBs being reinspected are more often found to be in compliance
than those being inspected for the first time.
The frequency of the inspections depends on the performance of
the IRB and the number of clinical studies it is monitoring.
FDA's approach to these inspections traditionally has
emphasized obtaining compliance through education, explanation
of requirements, and cooperation but the potential for
regulatory or administrative sanctions also is important.
The Agency has a very high standard for the quality of consent
forms and applies this stringent standard during its
inspections. We look to see whether the consent form includes
all the information required by our regulations and whether
there are areas in which the consent form could be improved, in
our judgment. (We recognize that even a consent form that we
find adequate, if submitted to other groups of persons, could
be modified to "improve" it further -- so to at least some
degree, the review of the adequacy of a consent form is
subjective.) One of the reasons why we assign the review of
consent documents to IRBs is because the IRB knows the most
about its potential subject population and is best able to
tailor the consent document to meet the information needs of
that subject population.

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