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

C. FDA's Educational Efforts
On our own and in cooperation with other professional and
governmental organizations, we strive to inform those
conducting and overseeing clinical research of how to meet
their responsibilities and why their doing so effectively is
important to protecting the rights and welfare of the human
subjects who rely on them.
FDA has developed a set of over two dozen information sheets
for IRBs and clinical investigators which address human subject
protection issues -- including informed consent -- where
questions or problems have arisen over the years. Each
information sheet package includes the Belmont Report and the
Declaration of Helsinki, important historical documents dealing
with informed consent which might not be readily available to
users, the FDA informed consent and IRB regulations, and a
self-evaluation checklist for IRBs, cross-referenced to the
regulations. FDA distributes the information sheets at
professional conferences and meetings, through an automated
facsimile system, and on FDA's home page on the World Wide Web.
More than 6,000 copies have been sent directly to IRBs and to
individuals who have requested them.
FDA staff frequently handle calls from IRB staff and members,
clinical investigators, regulated industry representatives, and
staff of other regulatory agencies on specific problem areas

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