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

The university was instructed to: (1) ensure that the IRB
receives and acts on all reports of unexpected adverse events
in order to protect adequately the rights and welfare of all
research subjects; (2) ensure that the IRB and the principal
investigators are informed of their mutual responsibilities for
initial and continuing review of IND studies, especially the
timely submission and review of all progress reports; and
(3) ensure that the informed consent documents meet FDA
requirements and that the clinical investigator only uses
informed consent documents approved by the IRB.
In March 1994, FDA lifted its restrictions against the
University after it agreed to correct the problems the Agency
had found and documented the plan to accomplish this objective.
At that time, FDA gave the university approval to again approve
studies and add new patients to ongoing studies.
B. FDA'sReview of Research Conducted Outside of the
United States
FDA's protections extend beyond our national borders. All
drug, biologic, and medical device studies conducted under an
investigational new drug application (IND) or an
investigational device application (IDE) are governed by FDA
informed consent and IRB requirements. Regardless of the
location of the research, our standard is the same.

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