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

and to give explanations of particular points in the
regulations. When these contacts raise general issues, they
are included in new information sheets. FDA also disseminates
its educational message through articles and regular columns in
professional journals. FDA's publications, including the
Medical Bulletin (distributed to health professionals
nationwide) and FDA Consumer, also include educational articles
on human subject protection issues.
Professional conferences are an important arena for FDA's
educational efforts. FDA recently held a one day national
conference on human subject protection that was attended by
over 500 people affiliated with IRBs, clinical research
studies, and other Federal agencies. Additionally, FDA looks
for opportunities to magnify the reach and effectiveness of its
educational efforts by working with other organizations. For
many years, FDA has cooperated with NIH's Office of Protection
from Research Risks in a series of several educational
conferences annually. The conferences are cosponsored by
universities, medical schools, or other nonprofit institutions
and are held in different parts of the country. A longstanding
collaboration similarly exists with the premier professional
organizations in the IRB field -- Public Responsibility in
Medicine and Research and the Applied Research Ethics National
Association. On a less regular basis, human subject protection
education efforts are made at meetings of other health

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