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)

Lisa Eckstein*, Annette Rid, Dorcas Kamuya, Seema K. Shah

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)2126-2130
Number of pages5
JournalClinical Infectious Diseases
Volume73
Issue number11
DOIs
StatePublished - Dec 1 2021
Externally publishedYes

Keywords

  • Clinical trials data monitoring committees
  • COVID-19 vaccines
  • Ethics
  • Research
  • SARS-CoV-2
  • Standard of care

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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