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Institutional Review Board: Management and Function , Second Edition

Author(s): Elizabeth A. Bankert, MA, Dartmouth IRB
Robert J. Amdur, MD, University of Florida College of Medicine, Gainesville, Florida
Details:
  • ISBN-13: 9780763730499
  • ISBN-10:0763730491
  • Hardcover    530 pages      © 2006
Price: International Sales $186.95 US List
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Overview

 

This comprehensive reference covers three separate areas related to IRBs: administration, daily management; and ethical issues. This instructional manual provides IRB members and administrators with the information they need to run an efficient and effective system of protecting human research subjects, while remaining in compliance with federal research regulations. The text includes case studies, sample forms, and sample policy documents.

 

The updated Second Edition includes seven new chapters:

  • IRB Closure of Study Files
  • Internet Research
  • Research in Public Schools
  • Phase I Clinical Trials in Healthy Volunteers
  • Vulnerability in Research
  • Balancing the Risks and Potential Benefits
  • HIPAA

View the accompanying Handbook! 

ShowTable of Contents

Part 1: Background and Overview Topics

Part 2: Organizing the Office

Part 3: Organizing the IRB Committee

Part 4: Review Categories

Part 5: Initial Protocol Review and The Full-Committee Meeting

Part 6: Informed Consent

Part 7: Continuing Review

Part 8: Administrative and Regulatory Issues

Part 9: Issues Based on Study Population

Part 10: IRB Issues Based on Study Design or Category


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ShowAbout the Author(s)

Elizabeth A. Bankert, MA-Dartmouth IRB

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 J. Amdur, MD-University of Florida College of Medicine, Gainesville, Florida

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.

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ShowReviews

  • “Institutional Review Board: Management and Function is truly a lifesaver—an absolutely invaluable resource for the burdened IRB staff professional or the overwhelmed committee reviewer. The book provides a refreshingly accessible resource to which the neophyte or experienced individual may turn for concise, current, tailored information, which covers the waterfront of the regulations, ethical codes, and law, as well as the experience of authoritative, seasoned experts daily engaged in the practice of IRB business.”

     

    -Philip A. Ludbrook and Courtney Beers

    PsycCRITIQUES

    Volume 51, Issue 47

     

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