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

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

Eckstein L; School of Law, University of Tasmania, Hobart, Australia.
Rid A; Clinical Center Department of Bioethics & Division of AIDS, National Institutes of Health, Bethesda, MarylandUSA.
Kamuya D; Health Systems and Research Ethics (HSRE) Department, Kenya Medical Research Institute (KEMRI)-Wellcome Trust Research Programme, Nairobi, Kenya.
Shah SK; Department of Pediatrics, Chicago, IllinoisUSA.

Clin Infect Dis ; 73(11): 2126-2130, 2021 12 06.

Article in English | MEDLINE | ID: covidwho-1561661

ABSTRACT

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.

Subject(s)

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

Keywords

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

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Vaccines / COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: Clin Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article Affiliation country: Cid

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