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The acceptability of delayed consent for prehospital emergency care research in the Western Cape province of South Africa

BACKGROUND: Informed consent is an essential prerequisite for enrolling patients into a study. Obtaining informed consent in an emergency is complex and often impossible. Delayed consent has been suggested for emergency care research. This study aims to determine the acceptability of prehospital eme...

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Autores principales: Stassen, Willem, Rambharose, Sanjeev, Wallis, Lee, Moodley, Keymanthri
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8782530/
https://www.ncbi.nlm.nih.gov/pubmed/35061748
http://dx.doi.org/10.1371/journal.pone.0262020
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author Stassen, Willem
Rambharose, Sanjeev
Wallis, Lee
Moodley, Keymanthri
author_facet Stassen, Willem
Rambharose, Sanjeev
Wallis, Lee
Moodley, Keymanthri
author_sort Stassen, Willem
collection PubMed
description BACKGROUND: Informed consent is an essential prerequisite for enrolling patients into a study. Obtaining informed consent in an emergency is complex and often impossible. Delayed consent has been suggested for emergency care research. This study aims to determine the acceptability of prehospital emergency care research with delayed consent in the Western Cape community of South Africa. METHODS: This study was an online survey of a stratified, representative sample of community members in the Western Cape province of South Africa. We calculated a powered sample size to be 385, and a stratified sampling method was employed. The survey was based on similar studies and piloted. Data were analysed descriptively. RESULTS: A total of 807 surveys were returned. Most respondents felt that enrolment into prehospital research would be acceptable if it offered direct benefit to them (n = 455; 68%) or if their condition was life-threatening and the research would identify improved treatment for future patients with a similar condition (n = 474; 70%). Similar results were appreciable when asked about the participation of their family member (n = 445; 66%) or their child (n = 422; 62%) regarding direct prospects of benefit. Overwhelmingly, respondents indicated that they would prefer to be informed of their own (n = 590; 85%), their family member’s (n = 593; 84%) or their child’s (n = 587; 86%) participation in a study immediately or as soon as possible. Only 35% (n = 283) agreed to retention data of deceased patients without the next of kin’s consent. CONCLUSION: We report majority agreement of respondents for emergency care research with delayed consent if the interventions offered direct benefit to the research participant, if the participant’s condition was life-threatening and the work held the prospect of benefit for future patients, and if the protocol for delayed consent was approved by a human research ethics committee. These results should be explored using qualitative methods.
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spelling pubmed-87825302022-01-22 The acceptability of delayed consent for prehospital emergency care research in the Western Cape province of South Africa Stassen, Willem Rambharose, Sanjeev Wallis, Lee Moodley, Keymanthri PLoS One Research Article BACKGROUND: Informed consent is an essential prerequisite for enrolling patients into a study. Obtaining informed consent in an emergency is complex and often impossible. Delayed consent has been suggested for emergency care research. This study aims to determine the acceptability of prehospital emergency care research with delayed consent in the Western Cape community of South Africa. METHODS: This study was an online survey of a stratified, representative sample of community members in the Western Cape province of South Africa. We calculated a powered sample size to be 385, and a stratified sampling method was employed. The survey was based on similar studies and piloted. Data were analysed descriptively. RESULTS: A total of 807 surveys were returned. Most respondents felt that enrolment into prehospital research would be acceptable if it offered direct benefit to them (n = 455; 68%) or if their condition was life-threatening and the research would identify improved treatment for future patients with a similar condition (n = 474; 70%). Similar results were appreciable when asked about the participation of their family member (n = 445; 66%) or their child (n = 422; 62%) regarding direct prospects of benefit. Overwhelmingly, respondents indicated that they would prefer to be informed of their own (n = 590; 85%), their family member’s (n = 593; 84%) or their child’s (n = 587; 86%) participation in a study immediately or as soon as possible. Only 35% (n = 283) agreed to retention data of deceased patients without the next of kin’s consent. CONCLUSION: We report majority agreement of respondents for emergency care research with delayed consent if the interventions offered direct benefit to the research participant, if the participant’s condition was life-threatening and the work held the prospect of benefit for future patients, and if the protocol for delayed consent was approved by a human research ethics committee. These results should be explored using qualitative methods. Public Library of Science 2022-01-21 /pmc/articles/PMC8782530/ /pubmed/35061748 http://dx.doi.org/10.1371/journal.pone.0262020 Text en © 2022 Stassen et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://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
Stassen, Willem
Rambharose, Sanjeev
Wallis, Lee
Moodley, Keymanthri
The acceptability of delayed consent for prehospital emergency care research in the Western Cape province of South Africa
title The acceptability of delayed consent for prehospital emergency care research in the Western Cape province of South Africa
title_full The acceptability of delayed consent for prehospital emergency care research in the Western Cape province of South Africa
title_fullStr The acceptability of delayed consent for prehospital emergency care research in the Western Cape province of South Africa
title_full_unstemmed The acceptability of delayed consent for prehospital emergency care research in the Western Cape province of South Africa
title_short The acceptability of delayed consent for prehospital emergency care research in the Western Cape province of South Africa
title_sort acceptability of delayed consent for prehospital emergency care research in the western cape province of south africa
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8782530/
https://www.ncbi.nlm.nih.gov/pubmed/35061748
http://dx.doi.org/10.1371/journal.pone.0262020
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