The Essential Role of Data and Safety Monitoring Boards (DSMBs) in Ensuring the Ethics of Global Vaccine Trials to Address Coronavirus Disease 2019 (COVID-19O)

Clin Infect Dis. 2021 Dec 6;73(11):2126-2130. doi: 10.1093/cid/ciab239.

Abstract

Coronavirus disease 2019 (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.

Keywords: COVID-19 vaccines; SARS-CoV-2; clinical trials data monitoring committees; ethics, research; standard of care.

Publication types

  • Research Support, N.I.H., Intramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • COVID-19 Vaccines
  • COVID-19*
  • Clinical Trials Data Monitoring Committees
  • Humans
  • SARS-CoV-2
  • Vaccines*

Substances

  • COVID-19 Vaccines
  • Vaccines