About this Guide:
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 of 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.
- Ethics and federal regulations
- Compliance with the HIPAA Privacy Rule
- Roles and responsibilities of federal agencies, institutions, IRBs and investigators
- Patient recruitment and retention
- Study result publication
- Informed consent
- Ethics in genetic research
- Research with secondary subjects, tissue studies and records review
- Clinical research professionals involved in the management and conduct of clinical trials
- IRB institutions and members actively involved in clinical trials
- Regulatory authorities involved in human subject protection
- Sponsors, CROs, SMOs, investigative sites and academic institutions to provide to their clinical researchers as a reference manual for conducting and managing clinical trials
*Readers can apply for a maximum of 6.75 AMA PRA Category 1 Credits. An exam is provided with each manual. To earn 6.75 CME hours, participants must earn a score of at least 85% on the exam no later than May 31, 2015.
*The University of Rochester School of Medicine and Dentistry is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
“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.
“I highly recommend this manual as a learning tool for clinical investigators and IRB members. It communicates the complexities of the ethics and regulations of human subject research in a well organized, clear, straightforward fashion.”
—Harold Vanderpool, Ph.D.,Th.M.
University of Texas Medical Branch