Data Safety Monitoring Boards

A Bioethical Perspective

Foreword by Janet Wittes
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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.
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.
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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.

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

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.

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additional book photo

Books for Asian American, Native Hawaiian, and Pacific Islander Heritage Month

Each May, we honor the stories, histories, and cultures of Asian Americans, Native Hawaiians, and Pacific Islanders. Below is a selection of acclaimed fiction and nonfiction books by AANHPI creators to share with your students this month and throughout the year. Find our full collection of titles for Higher Education here.

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