Informed consent rates for neonatal randomized controlled trials in low- and lower middle-income versus high-income countries: A systematic review

Jacquelyn K Patterson, Stuti Pant, Denise F Jones, Syed Taha, Michael S Jones, Melissa S Bauserman, Paolo Montaldo, Carl L Bose and Sudhin Thayyil

PLOS ONE, 2021, vol. 16, issue 3, 1-14

Abstract: Objective: Legal, ethical, and regulatory requirements of medical research uniformly call for informed consent. We aimed to characterize and compare consent rates for neonatal randomized controlled trials in low- and lower middle-income countries versus high-income countries, and to evaluate the influence of study characteristics on consent rates. Methods: In this systematic review, we searched MEDLINE, EMBASE and Cochrane for randomized controlled trials of neonatal interventions in low- and lower middle-income countries or high-income countries published 01/01/2013 to 01/04/2018. Our primary outcome was consent rate, the proportion of eligible participants who consented amongst those approached, extracted from the article or email with the author. Using a generalised linear model for fractional dependent variables, we analysed the odds of consenting in low- and lower middle-income countries versus high-income countries across control types and interventions. Findings: We screened 3523 articles, yielding 300 eligible randomized controlled trials with consent rates available for 135 low- and lower middle-income country trials and 65 high-income country trials. Median consent rates were higher for low- and lower middle-income countries (95.6%; interquartile range (IQR) 88.2–98.9) than high-income countries (82.7%; IQR 68.6–93.0; p

Date: 2021
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pone00:0248263

DOI: 10.1371/journal.pone.0248263

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