In:
PLOS ONE, Public Library of Science (PLoS), Vol. 16, No. 3 ( 2021-3-9), p. e0248263-
Abstract:
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 〈 0.001). In adjusted regression analysis comparing low- and lower middle-income countries to high-income countries, the odds of consent for no placebo-drug/nutrition trials was 3.67 (95% Confidence Interval (CI) 1.87–7.19; p = 0.0002) and 6.40 (95%CI 3.32–12.34; p 〈 0.0001) for placebo-drug/nutrition trials. Conclusion Neonatal randomized controlled trials in low- and lower middle-income countries report consistently higher consent rates compared to high-income country trials. Our study is limited by the overrepresentation of India among randomized controlled trials in low- and lower middle-income countries. This study raises serious concerns about the adequacy of protections for highly vulnerable populations recruited to clinical trials in low- and lower middle-income countries.
Type of Medium:
Online Resource
ISSN:
1932-6203
DOI:
10.1371/journal.pone.0248263
DOI:
10.1371/journal.pone.0248263.g001
DOI:
10.1371/journal.pone.0248263.g002
DOI:
10.1371/journal.pone.0248263.g003
DOI:
10.1371/journal.pone.0248263.g004
DOI:
10.1371/journal.pone.0248263.t001
DOI:
10.1371/journal.pone.0248263.t002
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10.1371/journal.pone.0248263.t003
DOI:
10.1371/journal.pone.0248263.t004
DOI:
10.1371/journal.pone.0248263.t005
DOI:
10.1371/journal.pone.0248263.s001
DOI:
10.1371/journal.pone.0248263.s002
DOI:
10.1371/journal.pone.0248263.s003
DOI:
10.1371/journal.pone.0248263.s004
DOI:
10.1371/journal.pone.0248263.s005
DOI:
10.1371/journal.pone.0248263.s006
DOI:
10.1371/journal.pone.0248263.s007
DOI:
10.1371/journal.pone.0248263.s008
DOI:
10.1371/journal.pone.0248263.s009
DOI:
10.1371/journal.pone.0248263.s010
DOI:
10.1371/journal.pone.0248263.r001
DOI:
10.1371/journal.pone.0248263.r002
DOI:
10.1371/journal.pone.0248263.r003
DOI:
10.1371/journal.pone.0248263.r004
Language:
English
Publisher:
Public Library of Science (PLoS)
Publication Date:
2021
detail.hit.zdb_id:
2267670-3
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