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The Ebola clinical trials: a precedent for research ethics in disasters

The West African Ebola epidemic has set in motion a collective endeavour to conduct accelerated clinical trials, testing unproven but potentially lifesaving interventions in the course of a major public health crisis. This unprecedented effort was supported by the recommendations of an ad hoc ethics...

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Autor principal: Calain, Philippe
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5749307/
https://www.ncbi.nlm.nih.gov/pubmed/27573153
http://dx.doi.org/10.1136/medethics-2016-103474
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author Calain, Philippe
author_facet Calain, Philippe
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description The West African Ebola epidemic has set in motion a collective endeavour to conduct accelerated clinical trials, testing unproven but potentially lifesaving interventions in the course of a major public health crisis. This unprecedented effort was supported by the recommendations of an ad hoc ethics panel convened in August 2014 by the WHO. By considering why and on what conditions the exceptional circumstances of the Ebola epidemic justified the use of unproven interventions, the panel's recommendations have challenged conventional thinking about therapeutic development and clinical research ethics. At the same time, unanswered ethical questions have emerged, in particular: (i) the specification of exceptional circumstances, (ii) the specification of unproven interventions, (iii) the goals of interventional research in terms of individual versus collective interests, (iv) the place of adaptive trial designs and (v) the exact meaning of compassionate use with unapproved interventions. Examination of these questions, in parallel with empirical data from research sites, will help build pragmatic foundations for disaster research ethics. Furthermore, the Ebola clinical trials signal an evolution in the current paradigms of therapeutic research, beyond the case of epidemic emergencies.
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spelling pubmed-57493072018-02-12 The Ebola clinical trials: a precedent for research ethics in disasters Calain, Philippe J Med Ethics Feature Article The West African Ebola epidemic has set in motion a collective endeavour to conduct accelerated clinical trials, testing unproven but potentially lifesaving interventions in the course of a major public health crisis. This unprecedented effort was supported by the recommendations of an ad hoc ethics panel convened in August 2014 by the WHO. By considering why and on what conditions the exceptional circumstances of the Ebola epidemic justified the use of unproven interventions, the panel's recommendations have challenged conventional thinking about therapeutic development and clinical research ethics. At the same time, unanswered ethical questions have emerged, in particular: (i) the specification of exceptional circumstances, (ii) the specification of unproven interventions, (iii) the goals of interventional research in terms of individual versus collective interests, (iv) the place of adaptive trial designs and (v) the exact meaning of compassionate use with unapproved interventions. Examination of these questions, in parallel with empirical data from research sites, will help build pragmatic foundations for disaster research ethics. Furthermore, the Ebola clinical trials signal an evolution in the current paradigms of therapeutic research, beyond the case of epidemic emergencies. BMJ Publishing Group 2018-01 2016-08-29 /pmc/articles/PMC5749307/ /pubmed/27573153 http://dx.doi.org/10.1136/medethics-2016-103474 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Feature Article
Calain, Philippe
The Ebola clinical trials: a precedent for research ethics in disasters
title The Ebola clinical trials: a precedent for research ethics in disasters
title_full The Ebola clinical trials: a precedent for research ethics in disasters
title_fullStr The Ebola clinical trials: a precedent for research ethics in disasters
title_full_unstemmed The Ebola clinical trials: a precedent for research ethics in disasters
title_short The Ebola clinical trials: a precedent for research ethics in disasters
title_sort ebola clinical trials: a precedent for research ethics in disasters
topic Feature Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5749307/
https://www.ncbi.nlm.nih.gov/pubmed/27573153
http://dx.doi.org/10.1136/medethics-2016-103474
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