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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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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2018
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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 |
author_sort | Calain, Philippe |
collection | PubMed |
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. |
format | Online Article Text |
id | pubmed-5749307 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
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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