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Leveraging Tele-Critical Care Capabilities for Clinical Trial Consent

A severe coronavirus disease 2019 patient admitted to our institution for medical management was enrolled in a randomized placebo-controlled trial of an investigational therapeutic for coronavirus disease 2019. We leveraged existing video-telecommunication equipment to obtain informed consent. We fo...

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Autores principales: Ieronimakis, Kristina M., Cain, Janell A., Switzer, Michael S., Odineal, David D., Deacy, Thomas K., Stein, Michael T. O., Colombo, Rhonda E., Colombo, Christopher J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer Health 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7339318/
https://www.ncbi.nlm.nih.gov/pubmed/32766563
http://dx.doi.org/10.1097/CCE.0000000000000167
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author Ieronimakis, Kristina M.
Cain, Janell A.
Switzer, Michael S.
Odineal, David D.
Deacy, Thomas K.
Stein, Michael T. O.
Colombo, Rhonda E.
Colombo, Christopher J.
author_facet Ieronimakis, Kristina M.
Cain, Janell A.
Switzer, Michael S.
Odineal, David D.
Deacy, Thomas K.
Stein, Michael T. O.
Colombo, Rhonda E.
Colombo, Christopher J.
author_sort Ieronimakis, Kristina M.
collection PubMed
description A severe coronavirus disease 2019 patient admitted to our institution for medical management was enrolled in a randomized placebo-controlled trial of an investigational therapeutic for coronavirus disease 2019. We leveraged existing video-telecommunication equipment to obtain informed consent. We found video-telecommunication use closely mirrored person-to-person contact for research consent by maintaining engagement and ensuring understanding. Video-telecommunication use facilitated clinical research while minimizing unnecessary exposure to coronavirus disease 2019 and conserving personal protective equipment. Prior to the coronavirus disease 2019 pandemic, research regulatory agencies were essentially silent on the matter of video-telecommunication consent. Regulatory guidance became available during the pandemic in response to increased isolation and social distancing practices. Virtual health and telemedicine use expanded greatly during the pandemic, and this increase will likely persist after the pandemic ends. We anticipate video-telecommunication adoption and implementation for research consent will also continue to grow after the coronavirus disease 2019 pandemic is over.
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spelling pubmed-73393182020-08-05 Leveraging Tele-Critical Care Capabilities for Clinical Trial Consent Ieronimakis, Kristina M. Cain, Janell A. Switzer, Michael S. Odineal, David D. Deacy, Thomas K. Stein, Michael T. O. Colombo, Rhonda E. Colombo, Christopher J. Crit Care Explor Commentary A severe coronavirus disease 2019 patient admitted to our institution for medical management was enrolled in a randomized placebo-controlled trial of an investigational therapeutic for coronavirus disease 2019. We leveraged existing video-telecommunication equipment to obtain informed consent. We found video-telecommunication use closely mirrored person-to-person contact for research consent by maintaining engagement and ensuring understanding. Video-telecommunication use facilitated clinical research while minimizing unnecessary exposure to coronavirus disease 2019 and conserving personal protective equipment. Prior to the coronavirus disease 2019 pandemic, research regulatory agencies were essentially silent on the matter of video-telecommunication consent. Regulatory guidance became available during the pandemic in response to increased isolation and social distancing practices. Virtual health and telemedicine use expanded greatly during the pandemic, and this increase will likely persist after the pandemic ends. We anticipate video-telecommunication adoption and implementation for research consent will also continue to grow after the coronavirus disease 2019 pandemic is over. Wolters Kluwer Health 2020-06-25 /pmc/articles/PMC7339318/ /pubmed/32766563 http://dx.doi.org/10.1097/CCE.0000000000000167 Text en Written work prepared by employees of the Federal Government as part of their official duties is, under the U.S. Copyright Act, a “work of the United States Government” for which copyright protection under Title 17 of the United States Code is not available. As such, copyright does not extend to the contributions of employees of the Federal Government. This article is made available via the PMC Open Access Subset for unrestricted re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the COVID-19 pandemic or until permissions are revoked in writing. Upon expiration of these permissions, PMC is granted a perpetual license to make this article available via PMC and Europe PMC, consistent with existing copyright protections.
spellingShingle Commentary
Ieronimakis, Kristina M.
Cain, Janell A.
Switzer, Michael S.
Odineal, David D.
Deacy, Thomas K.
Stein, Michael T. O.
Colombo, Rhonda E.
Colombo, Christopher J.
Leveraging Tele-Critical Care Capabilities for Clinical Trial Consent
title Leveraging Tele-Critical Care Capabilities for Clinical Trial Consent
title_full Leveraging Tele-Critical Care Capabilities for Clinical Trial Consent
title_fullStr Leveraging Tele-Critical Care Capabilities for Clinical Trial Consent
title_full_unstemmed Leveraging Tele-Critical Care Capabilities for Clinical Trial Consent
title_short Leveraging Tele-Critical Care Capabilities for Clinical Trial Consent
title_sort leveraging tele-critical care capabilities for clinical trial consent
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7339318/
https://www.ncbi.nlm.nih.gov/pubmed/32766563
http://dx.doi.org/10.1097/CCE.0000000000000167
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