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

subject protection violations or when a study sponsor or FDA
staff raise concerns about an investigator. If a clinical
investigator fails in his or her obligations, FDA can reject
the study, disqualify the clinical investigator from doing
additional studies, impose certain restrictions on carrying out
future clinical investigations, and in cases of fraud, pursue
criminal prosecution. The names of clinical investigators who
are disqualified or restricted are publicly available and can
be accessed through FDA's home page on the World Wide Web.
From 1993 through 1996, FDA disqualified four clinical
investigators and imposed restrictions on the investigational
drug use of six other clinical investigators.
FDA's Inspections of IRBs
The primary focus of FDA's IRB Program is the protection of the
rights and welfare of research subjects, rather than validating
the data obtained from research. FDA performs on-site
inspections of IRBs that review research involving products
that FDA regulates, including IRBs in academic institutions and
hospitals as well as those independent from where the research
will be conducted. All IRBs regardless of location or
affiliation are required to conform to the same regulations and
are inspected in accordance with the same compliance program.
The inspectional data show that there are similar findings
between types of IRBs. It has been demonstrated, however, that

12