Protecting Study Volunteers in Research: A Manual for Investigative Sites

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 (source: 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 include:
*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

Cynthia McGuire Dunn, M.D., is President of CMD Advisor in Rochester, N.Y., which specializes in clinical monitoring and drug development.

Gary L. Chadwick, Pharm.D., M.P.H., CIP, is Associate Provost and Director, Office for Human Subject Protection for the University of Rochester, and Associate Professor, Division of Medical Humanities at the University of Rochester School of Medicine and Dentistry.