Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America | 2021
The essential role of DSMBs in ensuring the ethics of global vaccine trials to address COVID-19
Abstract
Abstract COVID-19 vaccines are being developed and implemented with unprecedented speed. Accordingly, trials considered ethical at their inception may quickly become concerning. We provide recommendations for Data and Safety Monitoring Boards (DSMBs) on monitoring the ethical acceptability of COVID-19 vaccine trials, focusing on placebo-controlled trials in low- and middle-income countries.