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

practices that are so deficient that IRB review and approval
cannot be verified, or not obtaining adequate informed consent
from research subjects. FDA's sanctions include withholding
approval of new studies that would be conducted at the
institution or reviewed by the IRB, or directing that no new
subjects be added to ongoing studies until corrections are
made. In the most extreme cases of non-compliance, an IRB may
be disqualified from serving as an IRB. Since 1993,
approximately 59 warning letters have been issued and several
consent agreements have been signed. To date, no IRBs have
been formally disqualified by FDA, although several have ceased
operations following FDA inspections. FDA also may ask the
Department of Justice to initiate appropriate civil or criminal
proceedings.
The following is an example of an administrative action FDA has
taken with respect to an IRB for noncompliance with the
Agency's IRB regulations.
In early 1994, FDA sent a warning letter to a major university,
citing failure of the university and its IRB to protect
adequately the rights and welfare of subjects in research. In
this letter the Agency notified the IRB that it was no longer
authorized to approve new studies, [under 21 CFR 56.120(b) (1)],
and directed that no new patients be added to ongoing studies,
[under 21 CFR 56.120(b) (2)].

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