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Protecting Study Volunteers in Research

3.8 out of 5 stars 6 customer reviews
ISBN-13: 978-0967302911
ISBN-10: 0967302919
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Editorial Reviews

Review

"This manual and the included educational materials provide an excellent resource for investigator and staff training in research ethics and regulation. The authors have combined ethics and regulatory requirements together in a well-balanced format, and have then followed up with training focusing on both of these subjects. This manual will also serve as a useful resource for IRB members and other participants in the conduct and oversight of research involving human subjects." -- David Forster, J.D., M.A. - Director, Regulatory Affairs - Western Institutional Review Board

From the Publisher

Drs. Dunn and Chadwick of the University of Rochester School of Medicine & Dentistry have written the manual specifically for academic institutions actively involved in conducting clinical trials. The manual is also applicable to independent investigators. Developed in accordance with ACCME, readers can apply for CME Credits or Nursing Contact Hours. An exam is provided with each manual.
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Product Details

  • Paperback: 238 pages
  • Publisher: Centerwatch Inc (October 1, 1999)
  • Language: English
  • ISBN-10: 0967302919
  • ISBN-13: 978-0967302911
  • Product Dimensions: 0.8 x 5.8 x 8.8 inches
  • Shipping Weight: 15.2 ounces
  • Average Customer Review: 3.8 out of 5 stars  See all reviews (6 customer reviews)
  • Amazon Best Sellers Rank: #3,600,735 in Books (See Top 100 in Books)

Customer Reviews

Top Customer Reviews

This manual for investigative sites provides considerable insight and highly useful information into the protection of study volunteers. As an IRB member concerned with the ethical treatment and care of research subjects, I would absolutely recommend this book as "must reading" to clinical investigators and research coordinators. The regulations and glossary of terms are both current and easy to refer to. This book would serve as a great primer for new IRB members. William Hirschhorn
Adjunct Professor in Pharmaceutics Temple University School of Pharmacy Quality Assurance - Regulatory Affairs Graduate Program
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This manual for investigative sites provides considerable insight and highly useful information into the protection of study volunteers. As an IRB member concerned with the ethical treatment and care of research subjects, I would absolutely recommend this book as "must reading" for clinical investigators and research coordinators. The regulations and glossary of terms are both current and easy to refer to. This book would serve as a great primer for new IRB members. William Hirschhorn
Covance, Director of Clinical Research Education, Investigative Site Services (e-CRO) Adjunct Professor in Pharmaceutics Temple University School of Pharmacy Quality Assurance - Regulatory Affairs Graduate Program
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I thought this was an excellent outline for Researchers, IRB members, Research Compliance Officers, etc. It covers the history of human research, ethics, roles and responsibilities of researchers and the institutions, federal regulations, behaviorial research issues and publication of study results. As a new Research Compliance Officer, it has served as an excellent learning tool for me. I am sharing this book with our new IRB members to facilitate their orientation to the IRB. Plus, it is a good way for PI's to get CEU's for their licensure.
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