Informed consent rates for neonatal randomized controlled trials in low- and lower middle-income versus high-income countries: a systematic review
Author(s)
Type
Journal Article
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<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.
Date Issued
2021-03-09
Online Publication Date
2021-04-29T16:09:37Z
Date Acceptance
2021-02-17
ISSN
1932-6203
Publisher
Public Library of Science (PLoS)
Start Page
1
End Page
14
Journal / Book Title
PLoS One
Volume
16
Issue
3
Copyright Statement
© 2021 Patterson et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
License URI
Sponsor
National Institute for Health Research
National Institute for Health Research
Identifier
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0248263
http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000627855600034&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
Grant Number
NIHR200144
NIHR300118
Subjects
Science & Technology
Multidisciplinary Sciences
Science & Technology - Other Topics
Science & Technology
Multidisciplinary Sciences
Science & Technology - Other Topics
General Science & Technology
Publication Status
Published
Article Number
ARTN e0248263
Date Publish Online
2021-03-09