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Informed consent rates for neonatal randomized controlled trials in low- and lower middle-income versus high-income countries: A systematic review
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 inf...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7943024/ https://www.ncbi.nlm.nih.gov/pubmed/33690703 http://dx.doi.org/10.1371/journal.pone.0248263 |
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author | Patterson, Jacquelyn K. Pant, Stuti Jones, Denise F. Taha, Syed Jones, Michael S. Bauserman, Melissa S. Montaldo, Paolo Bose, Carl L. Thayyil, Sudhin |
author_facet | Patterson, Jacquelyn K. Pant, Stuti Jones, Denise F. Taha, Syed Jones, Michael S. Bauserman, Melissa S. Montaldo, Paolo Bose, Carl L. Thayyil, Sudhin |
author_sort | Patterson, Jacquelyn K. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-7943024 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-79430242021-03-19 Informed consent rates for neonatal randomized controlled trials in low- and lower middle-income versus high-income countries: A systematic review Patterson, Jacquelyn K. Pant, Stuti Jones, Denise F. Taha, Syed Jones, Michael S. Bauserman, Melissa S. Montaldo, Paolo Bose, Carl L. Thayyil, Sudhin PLoS One Research Article 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. Public Library of Science 2021-03-09 /pmc/articles/PMC7943024/ /pubmed/33690703 http://dx.doi.org/10.1371/journal.pone.0248263 Text en © 2021 Patterson et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
spellingShingle | Research Article Patterson, Jacquelyn K. Pant, Stuti Jones, Denise F. Taha, Syed Jones, Michael S. Bauserman, Melissa S. Montaldo, Paolo Bose, Carl L. Thayyil, Sudhin Informed consent rates for neonatal randomized controlled trials in low- and lower middle-income versus high-income countries: A systematic review |
title | Informed consent rates for neonatal randomized controlled trials in low- and lower middle-income versus high-income countries: A systematic review |
title_full | Informed consent rates for neonatal randomized controlled trials in low- and lower middle-income versus high-income countries: A systematic review |
title_fullStr | Informed consent rates for neonatal randomized controlled trials in low- and lower middle-income versus high-income countries: A systematic review |
title_full_unstemmed | Informed consent rates for neonatal randomized controlled trials in low- and lower middle-income versus high-income countries: A systematic review |
title_short | Informed consent rates for neonatal randomized controlled trials in low- and lower middle-income versus high-income countries: A systematic review |
title_sort | informed consent rates for neonatal randomized controlled trials in low- and lower middle-income versus high-income countries: a systematic review |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7943024/ https://www.ncbi.nlm.nih.gov/pubmed/33690703 http://dx.doi.org/10.1371/journal.pone.0248263 |
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