Protecting Study Volunteers in Research: A Manual for Investigative Sites

by Gary L. Chadwick, Gary L. Chadwick, Cynthia McGuire Dunn

This well-organized and concise manual teaches organizations how to successfully implement the highest standards of safe and ethical treatment of study volunteers while addressing current and emerging issues that are critical to our system of human subject protection oversight.

Protecting Study Volunteers in Research is a suggested educational resource by NIH and FDA ( NIH Notice OD-00-039, 2000, page 37841, Federal Registry 2002) and has become required reading in many academic institutions, IRBs, investigative sites, and for many Biopharmaceutical and CRO companies.

Written by Cynthia Dunn, M.D. of Western Institutional Review Board and Gary Chadwick, Pharm.D., M.P.H. of the University of Rochester, this manual has been developed in accordance with ACCME. Readers can apply for CME credits or nursing contact hours. An exam is provided with each manual and is also available online.

Topics covered
*Conflicts of interest in research
*Participant recruitment and retention in clinical trials
*Research with secondary subjects, tissue studies, and records review
*Historical perspectives on human subject research
*Updated ethics and federal regulations
*Roles and responsibilities of institutions and independent sites
*Roles and responsibilities of investigators and the study process

Genres: Science

382 pages, Paperback

First published April 1, 2002

Reviews

[Tcrimmel]

I am in the process of reading this book. The course content is exceptional and full of relevant FDA material. This book helps to build a basis for the need for improved standard in testing of human subjects.