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Data Safety Monitoring Boards

A Bioethical Perspective

Part of Basic Bioethics

Author Deborah R. Barnbaum
Foreword by Janet Wittes
Ebook (EPUB)
The MIT Press
On sale Aug 12, 2025 | 202 Pages | 9780262383622
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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.
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.
Deborah R. Barnbaum View titles by Deborah R. Barnbaum
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

About

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.

Author

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.
Deborah R. Barnbaum View titles by Deborah R. Barnbaum

Table of Contents

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

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