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

doi:10.1093/cid/ciab239

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 journal › Review article › peer-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 language	English (US)
Pages (from-to)	2126-2130
Number of pages	5
Journal	Clinical Infectious Diseases
Volume	73
Issue number	11
DOIs	https://doi.org/10.1093/cid/ciab239
State	Published - Dec 1 2021
Externally published	Yes

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

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1093/cid/ciab239

Cite this

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title = "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)",

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

author = "Lisa Eckstein and Annette Rid and Dorcas Kamuya and Shah, {Seema K.}",

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year = "2021",

month = dec,

day = "1",

doi = "10.1093/cid/ciab239",

language = "English (US)",

volume = "73",

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journal = "Clinical Infectious Diseases",

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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). / Eckstein, Lisa; Rid, Annette; Kamuya, Dorcas; Shah, Seema K.

In: Clinical Infectious Diseases, Vol. 73, No. 11, 01.12.2021, p. 2126-2130.

Research output: Contribution to journal › Review article › peer-review

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AU - Eckstein, Lisa

AU - Rid, Annette

AU - Kamuya, Dorcas

AU - Shah, Seema K.

PY - 2021/12/1

Y1 - 2021/12/1

N2 - 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.

AB - 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.

KW - Clinical trials data monitoring committees

KW - COVID-19 vaccines

KW - Ethics

KW - Research

KW - SARS-CoV-2

KW - Standard of care

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DO - 10.1093/cid/ciab239

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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)

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

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