Data Safety Monitoring Boards

A Bioethical Perspective

by

Published 2025 by MIT Press.

ISBN:
978-0-262-38363-9
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(2 reviews)

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.

2 editions

reviewed Data Safety Monitoring Boards by Deborah R. Barnbaum

A Case-Focused Introduction

This is a great introduction to data safety monitoring boards, using cases to illustrate how these unique teams operate within clinical trials. Medicine is so far ahead of other fields in systematizing ethical processes, and while many introductions focus on IRBs or the Belmont Report, this book goes into detail on how these rarely discussed boards function and how different stakeholders should think about their role. If you deal at all with human experimentation (this includes technology products and management), this is a good book to pick up. Highly recommend

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