Data Safety Monitoring Boards

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.