A critical and underexplored area of bioethics-ethical issues that emerge from the data monitoring of clinical trials.
A critical and underexplored area of bioethics-ethical issues that emerge from the data monitoring of clinical trials.
Data Safety Monitoring Boards explores ethical issues confronted by data safety monitoring boards, or DSMBs, overseeing large randomized clinical trials. DSMBs meet on a regular basis to ensure that the expected benefits of a study continue to outweigh its risks and that side effects are monitored. They are empowered to recommend to study sponsors that studies be halted if ethical protections fail.
Written by bioethicist Deborah Barnbaum, who has served as a clinical ethicist and patient advocate on several DSMBs for the National Institutes of Health since 2006, this book combines compelling narratives about clinical trials, the ethical quandaries that emerge when overseeing those studies, and the theoretical considerations that guide the practices of DSMBs.
By:
Deborah R. Barnbaum
Imprint: MIT Press
Country of Publication: United States
Dimensions:
Height: 229mm,
Width: 152mm,
Weight: 369g
ISBN: 9780262552745
ISBN 10: 0262552744
Pages: 202
Publication Date: 16 September 2025
Audience:
General/trade
,
ELT Advanced
Format: Paperback
Publisher's Status: Active
Contents Foreword by Janet Wittes Acknowledgments Introduction Chapter 1: What Are Data Safety Monitoring Boards, and What is Their Role? Chapter 2: What Does an Ethicist Bring to the DSMB? – The STRIVE-IPF Trial Chapter 3: Measuring Risks – The CALEC Trial Chapter 4: Equipoise and Stopping Studies – Protocols AG and AH Chapter 5: Recruitment, Retention, and Keeping Vulnerable Participants Safe – The SIGHT Trial Chapter 6: The Theoretical Foundation of DSMB Deliberations Endnotes Bibliography Index
Deborah R. Barnbaum is Professor of Philosophy at Kent State University. In 2009, she received the bronze medal in the Health/Medicine/Nutrition category of the Independent Book Publishers Awards for her book The Ethics of Autism.
