Synopsis
Clinical research professionals need a direct, practical guide to working together to protect human research subjects. This book is a reference for research sponsors, investigators, and IRB members, with documents created by the Biomedical Research Alliance of New York: - Sample pediatric subject assent form - Sample HIPAA authorization form - Sample assent form for genetic testing and/or tissue banking - Sample evaluation/feedback tool for educational programs - Glossary of lay terms for preparing informed-consent documents. - Nuremberg Code, Declaration of Helsinki, Belmont Report, the "Common Rule" are included.
About the Author
Deirdre Hall, CCRC, CCRA, CIP, is Manager for Quality Standards at Pfizer Pharmaceuticals Group, New York, N.Y. Eileen Hilton, MD, is President and CEO of the Biomedical Research Alliance of New York, Great Neck, N.Y., and is a Professor of Clinical Medicine at Albert Einstein College of Medicine.
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