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Protocol for Deferral of Consent in Acute Stroke Trials

The challenges of conducting hyperacute stroke research and obtaining informed consent have been increasingly recognized within the stroke research community in recent years. Deferral of consent, in which a patient is enrolled in a trial and then provides consent at some point thereafter, is increas...

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Autores principales: Faris, Hannah, Dewar, Brian, Fedyk, Mark, Dowlatshahi, Dar, Menon, Bijoy, Swartz, Richard H., Hill, Michael D., Shamy, Michel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9946194/
https://www.ncbi.nlm.nih.gov/pubmed/36414423
http://dx.doi.org/10.1212/WNL.0000000000201533
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author Faris, Hannah
Dewar, Brian
Fedyk, Mark
Dowlatshahi, Dar
Menon, Bijoy
Swartz, Richard H.
Hill, Michael D.
Shamy, Michel
author_facet Faris, Hannah
Dewar, Brian
Fedyk, Mark
Dowlatshahi, Dar
Menon, Bijoy
Swartz, Richard H.
Hill, Michael D.
Shamy, Michel
author_sort Faris, Hannah
collection PubMed
description The challenges of conducting hyperacute stroke research and obtaining informed consent have been increasingly recognized within the stroke research community in recent years. Deferral of consent, in which a patient is enrolled in a trial and then provides consent at some point thereafter, is increasingly used to enroll patients into hyperacute stroke trials in Canada and Europe, although it is not permitted in the United States. Deferral of consent offers several potential advantages—quicker door-to-randomization, increased enrolment, decreased selection bias—but these must be balanced against the risk of enrolling patients against their wishes. We seek to minimize the attendant risks of deferral of consent by offering practical guidance regarding how to conduct acute stroke trials using deferral of consent. Building on existing guidelines and recent experiences with deferral of consent in acute stroke trials, we have developed a protocol for the use of deferral of consent that aims to maximize patient involvement while minimizing ethical and scientific risks.
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spelling pubmed-99461942023-02-23 Protocol for Deferral of Consent in Acute Stroke Trials Faris, Hannah Dewar, Brian Fedyk, Mark Dowlatshahi, Dar Menon, Bijoy Swartz, Richard H. Hill, Michael D. Shamy, Michel Neurology Research Methods in Neurology The challenges of conducting hyperacute stroke research and obtaining informed consent have been increasingly recognized within the stroke research community in recent years. Deferral of consent, in which a patient is enrolled in a trial and then provides consent at some point thereafter, is increasingly used to enroll patients into hyperacute stroke trials in Canada and Europe, although it is not permitted in the United States. Deferral of consent offers several potential advantages—quicker door-to-randomization, increased enrolment, decreased selection bias—but these must be balanced against the risk of enrolling patients against their wishes. We seek to minimize the attendant risks of deferral of consent by offering practical guidance regarding how to conduct acute stroke trials using deferral of consent. Building on existing guidelines and recent experiences with deferral of consent in acute stroke trials, we have developed a protocol for the use of deferral of consent that aims to maximize patient involvement while minimizing ethical and scientific risks. Lippincott Williams & Wilkins 2023-02-07 /pmc/articles/PMC9946194/ /pubmed/36414423 http://dx.doi.org/10.1212/WNL.0000000000201533 Text en Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND) (https://creativecommons.org/licenses/by-nc-nd/4.0/) , which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
spellingShingle Research Methods in Neurology
Faris, Hannah
Dewar, Brian
Fedyk, Mark
Dowlatshahi, Dar
Menon, Bijoy
Swartz, Richard H.
Hill, Michael D.
Shamy, Michel
Protocol for Deferral of Consent in Acute Stroke Trials
title Protocol for Deferral of Consent in Acute Stroke Trials
title_full Protocol for Deferral of Consent in Acute Stroke Trials
title_fullStr Protocol for Deferral of Consent in Acute Stroke Trials
title_full_unstemmed Protocol for Deferral of Consent in Acute Stroke Trials
title_short Protocol for Deferral of Consent in Acute Stroke Trials
title_sort protocol for deferral of consent in acute stroke trials
topic Research Methods in Neurology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9946194/
https://www.ncbi.nlm.nih.gov/pubmed/36414423
http://dx.doi.org/10.1212/WNL.0000000000201533
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