Protecting Study Volunteers in Research, 2nd Edition

This brand new second edition of our top-selling manual has doubled in size to address 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 was designed to help organizations provide the highest standards of safe and ethical treatment of study volunteers. This manual will be routinely referenced for ethical considerations and insights, and for a comprehensive review of regulations and guidelines not conveniently found elsewhere.

Protecting Study Volunteers in Research has become required reading in many academic institutions, IRBs and investigative sites and is a suggested training resource by regulatory agencies and research sponsors. Biopharmaceutical and CRO companies have also made this manual mandatory reading for their staff.

Written by Cynthia Dunn, M.D. of Western Institutional Review Board and Gary Chadwick, PharmD., M.P.H. of the University of Rochester, Protecting Study Volunteers in Research 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.

Book features:

- Conflict of interest and disclosure
- Participant Recruitment and Retention in Clinical Trials
- Research with Secondary Subjects, Tissue Banks, Repositories, Databases 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 study staff

I highly recommend this revised and expanded manual as a learning tool for clinical investigators and IRB members. -- Harold Y. Vanderpool, Ph.D., Th.M., Professor of the History and Philosophy of Medicine, University of Texas Medical Branch

The material is well-chosen, clearly described and in a form conducive to its utility in continuing education. -- Louis Lasagna, MD, Dean, Sackler School of Graduate Biomedical Sciences, Tufts University