Protecting Study Volunteers in Research

By Gary L. Chadwick and Cynthia McGuire-Dunn

Book Overview

This soft-cover manual presents comprehensive guidelines and references to assist clinical research professionals in providing the highest standards of safety and ethical treatment for their human... This description may be from another edition of this product.

• Format: Paperback
• Language: English
• ISBN: 0967302919
• ISBN13: 9780967302911
• Release Date: October 1999
• Publisher: Centerwatch Inc
• Length: 238 Pages
• Weight: 0.94 lbs.
• Dimensions: 8.8" x 0.8" x 5.8"

Customer Reviews

Good training material for sites and IRBs

Does a good job of outlining the basics in an easy to digest format. We've made it part of new IRB staff and member training.

Comprehensive Content Makes for Excellent Educational Tool

"Protecting Study Volunteers in Clinical Research" provides a very comprehensive overview of the federal regulations which govern clinical research in a very concise and accurate manner. It is very easy to read. It makes for an excellent educational tool for investigators, coordinators, administrative personnel, and IRB members. I would recommend this book to anyone who is involved in clinical research.

Protecting Study Volunteers in Research

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.

Must reading for protecting research subjects

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 HirschhornAdjunct Professor in Pharmaceutics Temple University School of Pharmacy Quality Assurance - Regulatory Affairs Graduate Program

Must reading for protecting research subjects

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 HirschhornCovance, 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