Protecting Study Volunteers in Research: A Manual for Investigative Sites, Fifth Edition

Are you up to date on developments for protecting your trial participants?

If you’re running trials, relying on outdated knowledge could be putting them at risk. Longstanding principles and practices have been upended by groundbreaking developments in clinical research as well as changes brought about by COVID-19.

Enter what has been the industry’s leading resource on protecting clinical trial participants for more than 20 years: Protecting Study Volunteers in Research: A Manual for Investigative Sites, Fifth Edition.

Throughout this edition, you’ll benefit from the expertise and insights of clinical trial professionals from academia, industry and medical practice. Their 360-degree view of important issues, including genetic research … the ethnicity of participants … requirements of informed consent … and more, will ensure you’re doing right by your trial participants.

Key Manual Highlights:

• Federal regulations related to keeping clinical trial participants safe
• Protection issues related to social science research (behavioral and observational studies)
• Ethics and implications of informed consent
• How accurate publication of trial results protects participants and the public
• The effect of financial conflicts of interest and scientific misconduct on clinical research
• Issues involved in increasing participant diversity
• The impact of HIPAA regulations on clinical trial data
• Issues presented by the growth of genetic research and precision medicine

Bonus! The appendix contains the text of FDA human subject protection regulations; the Common Rule; and a copy of the Belmont Report, on which human subject principles are based.

Protecting Study Volunteers in Research: A Manual for Investigative Sites includes all the developments you must consider to ensure your trial participants are informed, empowered and — above all — as safe as possible. Order your copy today.

About the Contributors

This manual was written by a variety of clinical research professionals — investigators, IRB representatives, medical school professors, former federal officials, sponsor representatives and clinical statisticians — led by primary author Gary Chadwick, PharmD, MPH.

Dr. Chadwick is associate provost at the University of Rochester (retired) and former professor of clinical community and preventive medicine and medical humanities in the university’s School of Medicine and Dentistry. He also directed the school’s Office for Human Subject Protection, which is responsible for the operation and support of the university's IRB system. Dr. Chadwick was a commissioned officer in the U.S. Public Health Service for more than 26 years. He served in the FDA and in the Office for Protection from Research Risks at the NIH. He was the founding chair of the ARENA Council for Certification of IRB Professionals.

Contributing authors to this edition include:

• Angela Branche, associate professor, infectious diseases, University of Rochester School of Medicine and Dentistry
• Nancy Perini Chin, associate professor, undergraduate public health programs, multidisciplinary studies, University of Rochester
• Ann Dozier, professor and chair, department of public health sciences, University of Rochester School of Medicine and Dentistry
• Joanne Larson, associate director of research, Warner School of Education, University of Rochester
• Kelley O’Donoghue, associate VP for human subject protection, University of Rochester
• Anita Naik, systems integration associate, athenahealth