Protecting Study Volunteers in Research

Human subject protection is one of the most concerning aspects of the clinical trials process requiring rigorous compliance and ethical standards. Now in its fourth edition, Protecting Study Volunteers in Research continues to be the industry s leading resource on the subject teaching clinical research professionals how to successfully implement the highest standards of safe and ethical treatment of study volunteers while addressing current and emerging issues that are vital to human subject protection and successful clinical trial outcomes.

From historical perspectives to study publication and everything in between, this invaluable resource is not only a training manual, but an enlightening and practical reference as well. Written in a concise and logical format, this text presents practical and relevant topics of research involving human subjects with remarkable clarity, insight and reason. Those who work in the field will profit from this resource; it is a valuable title that includes everything you need, and nothing you don t! --Kian Merchant-Borna, MPH, CCRC, Department of Emergency Medicine, University of Rochester Medical Center

The authors have combined ethics and regulatory requirements together in a well-balanced format. 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., CIP, Chief Compliance Officer Office of Compliance, Western Institutional Review Board

This manual is the standard concise reference for human research subject protection rules and ethical obligations. It is my first source for IRB professional certification and general GCP training. --Paul W. Goebel, CIP, President, Paul W. Goebel Consulting, Inc.