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. We provide recommendations for Data and Safety Monitoring Boards (DSMBs) on monitoring the ethical acceptability of coronavirus disease 2019 (COVID-19) vaccine trials, focusing on placebo-controlled trials in low- and middle-income countries.
All Keywords
【저자키워드】 SARS-CoV-2, COVID-19 vaccines, Standard of care, Clinical Trials Data Monitoring Committees, ethics, research, 【초록키워드】 COVID-19, coronavirus disease, Coronavirus disease 2019, Vaccine, Trial, placebo-controlled trial, trials, COVID-19 vaccine trials, recommendation, concerning, Safety Monitoring Board, 【제목키워드】 Ethics, role, address, Ensuring, Essential, Safety Monitoring Board,
【저자키워드】 SARS-CoV-2, COVID-19 vaccines, Standard of care, Clinical Trials Data Monitoring Committees, ethics, research, 【초록키워드】 COVID-19, coronavirus disease, Coronavirus disease 2019, Vaccine, Trial, placebo-controlled trial, trials, COVID-19 vaccine trials, recommendation, concerning, Safety Monitoring Board, 【제목키워드】 Ethics, role, address, Ensuring, Essential, Safety Monitoring Board,