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

The most common deficiencies that we find are: 1) lack of
clarity about the person to contact if there are questions
concerning the research and the research subject's rights in
the event of a research related injury; 2) inadequate
description of the research procedures to be followed; 3)
inadequate description of available compensation if the subject
sustains injury as a result of the research; 4) inadequate
confidentiality statement; and, 5) inadequate description of
alternative procedures that are available to subjects should
they choose not to participate in the research.3 A deficiency
in the informed consent document does not necessarily mean that
the informed consent process was inadequate. It is the
interactive information exchange that is most important to the
informed consent process. FDA focuses on the consent form
during our inspections because it is the best evidence that we
have of the basic information that was exchanged during that
2
process.
FDA can impose administrative sanctions when necessary to
protect human subjects of research and in cases of significant
non-compliance. Significant non-compliance may include
inadequate review of studies, inadequate record-keeping
3 FDA recently published a final rule requiring informed
consent documents to be dated at the time of signature (61 FR
57278, November 5, 1996). Although a common practice, this was
not previously required by regulation. This new rule permits FDA
to verify that consent was obtained prior to a subject's entry
into a study.

14