#8351. A literature review of consent declines and consent withdrawals in randomized controlled trials conducted during the COVID-19 pandemic

August 2026publication date
Proposal available till 10-05-2025
4 total number of authors per manuscript0 $

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Journal’s subject area:
Medicine (all);
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Abstract:
Objectives: We evaluated the extent of consent declines and consent withdrawals during the COVID-19 pandemic as seen in published randomized controlled trials (RCTs) and compared it with non-COVID-19 RCTs published at the same time and two historical controls. Methods: PubMed/Medline only was searched using key-word COVID-19 and RCTs separately, and filtered for COVID-19 RCTs and non-COVID-19 RCTs respectively, published during a nine-month period (1 Feb - 1 Nov 20XX). Exclusions were study protocols, observational studies, interim analysis of RCT data and RCTs with missing data. Primary outcome measures were the proportion of consent declines and consent withdrawals as percentage of total participants screened and randomized respectively in COVID-19 RCTs. We compared consent declines and consent withdrawals of COVID-19 RCTs with non-COVID-19 RCTs and two earlier studies on the same topic that served as historical controls (non-pandemic setting).
Keywords:
Consent declines; consent withdrawal; COVID-19; randomized controlled trial; vaccine.

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