Consent concerns in clinical trials of investigational therapies for COVID-19: Vulnerability versus voluntariness

Obtaining informed consent from vulnerable patients participating in clinical trials of investigational therapies for COVID-19 is a major ethical challenge. Ethical and operational considerations – voluntariness, waiver, timing, time, documentation, and responsibilities of the sponsor, the investiga...

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Autor principal: Bhatt, Arun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer - Medknow 2020
Materias:
Ethics Education
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7819368/
https://www.ncbi.nlm.nih.gov/pubmed/33489836
http://dx.doi.org/10.4103/picr.PICR_271_20
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author Bhatt, Arun
author_facet Bhatt, Arun
author_sort Bhatt, Arun
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description Obtaining informed consent from vulnerable patients participating in clinical trials of investigational therapies for COVID-19 is a major ethical challenge. Ethical and operational considerations – voluntariness, waiver, timing, time, documentation, and responsibilities of the sponsor, the investigator, and the ethics committee – are discussed briefly.
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spelling pubmed-78193682021-01-22 Consent concerns in clinical trials of investigational therapies for COVID-19: Vulnerability versus voluntariness Bhatt, Arun Perspect Clin Res Ethics Education Obtaining informed consent from vulnerable patients participating in clinical trials of investigational therapies for COVID-19 is a major ethical challenge. Ethical and operational considerations – voluntariness, waiver, timing, time, documentation, and responsibilities of the sponsor, the investigator, and the ethics committee – are discussed briefly. Wolters Kluwer - Medknow 2020 2020-10-06 /pmc/articles/PMC7819368/ /pubmed/33489836 http://dx.doi.org/10.4103/picr.PICR_271_20 Text en Copyright: © 2020 Perspectives in Clinical Research http://creativecommons.org/licenses/by-nc-sa/4.0 This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.
spellingShingle Ethics Education
Bhatt, Arun
Consent concerns in clinical trials of investigational therapies for COVID-19: Vulnerability versus voluntariness
title Consent concerns in clinical trials of investigational therapies for COVID-19: Vulnerability versus voluntariness
title_full Consent concerns in clinical trials of investigational therapies for COVID-19: Vulnerability versus voluntariness
title_fullStr Consent concerns in clinical trials of investigational therapies for COVID-19: Vulnerability versus voluntariness
title_full_unstemmed Consent concerns in clinical trials of investigational therapies for COVID-19: Vulnerability versus voluntariness
title_short Consent concerns in clinical trials of investigational therapies for COVID-19: Vulnerability versus voluntariness
title_sort consent concerns in clinical trials of investigational therapies for covid-19: vulnerability versus voluntariness
topic Ethics Education
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7819368/
https://www.ncbi.nlm.nih.gov/pubmed/33489836
http://dx.doi.org/10.4103/picr.PICR_271_20
work_keys_str_mv AT bhattarun consentconcernsinclinicaltrialsofinvestigationaltherapiesforcovid19vulnerabilityversusvoluntariness

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