Institutional Review Board: Management and Function

This book is designed as an instructional manual that gives Institutional Review Board (IRB) members and administrators the information they need to run an efficient and effective system of protecting human research subjects, in compliance with federal research regulations. This reference provides a step-by-step approach to practical details of IRB administration and includes case studies, sample forms, and sample policy documents, as well as decision-making algorithms and lists of approval criteria for their resolution.
Elizabeth Bankert has been the Administrative Director of the IRB at Dartmouth College/Dartmouth Hitchcock Medical Center for ten years. She is a past president of Applied Research Ethics National Association (ARENA), a national membership organization comprised of over 2,000 IRB professionals, members, and researchers. Liz has made numerous presentations at institutions throughout the country as an invited speaker on topics ranging from Adverse Event Report to Research Involving Incompetent Patients. Liz's most recent endeavor is a collaboration with Robert (Skip) Nelson, MD at Children's Hospital of Philadelphia in the creation of a web-based site referred to as IRBNet. The primary mission of IRBNet is to create an effective and efficient means of education and communication between sponsors, IRBs, and researchers with the goal of enhancing and streamlining the processes involved with research involving human subjects. IRBNet can be found at www.irbnet.org.
Robert Amdur was a member and Chairman of the IRB at Dartmouth College/Dartmouth Hitchcock Center for several years. Dr. Amdur currently focuses on advancing medicine in the field of radiation oncology.