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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)
- Source :
- Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
- Publication Year :
- 2021
- Publisher :
- Oxford University Press (OUP), 2021.
-
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.
- Subjects :
- Ethics
Microbiology (medical)
Vaccines
2019-20 coronavirus outbreak
COVID-19 Vaccines
Standard of care
Coronavirus disease 2019 (COVID-19)
SARS-CoV-2
business.industry
Research
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
education
COVID-19
Standard of Care
Safety Monitoring Boards
medicine.disease
Viewpoints Article
AcademicSubjects/MED00290
Infectious Diseases
Humans
Medicine
Medical emergency
Clinical Trials Data Monitoring Committees
business
Subjects
Details
- ISSN :
- 15376591 and 10584838
- Volume :
- 73
- Database :
- OpenAIRE
- Journal :
- Clinical Infectious Diseases
- Accession number :
- edsair.doi.dedup.....59e1ceb451aa8338c2f729a8234df9c6