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Research Ethics Governance in Times of Ebola

The Médecins Sans Frontières (MSF) ethics review board (ERB) has been solicited in an unprecedented way to provide advice and review research protocols in an ‘emergency’ mode during the recent Ebola epidemic. Twenty-seven Ebola-related study protocols were reviewed between March 2014 and August 2015...

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Autores principales: Schopper, Doris, Ravinetto, Raffaella, Schwartz, Lisa, Kamaara, Eunice, Sheel, Sunita, Segelid, Michael J., Ahmad, Aasim, Dawson, Angus, Singh, Jerome, Jesani, Amar, Upshur, Ross
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5444563/
https://www.ncbi.nlm.nih.gov/pubmed/28567113
http://dx.doi.org/10.1093/phe/phw039
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author Schopper, Doris
Ravinetto, Raffaella
Schwartz, Lisa
Kamaara, Eunice
Sheel, Sunita
Segelid, Michael J.
Ahmad, Aasim
Dawson, Angus
Singh, Jerome
Jesani, Amar
Upshur, Ross
author_facet Schopper, Doris
Ravinetto, Raffaella
Schwartz, Lisa
Kamaara, Eunice
Sheel, Sunita
Segelid, Michael J.
Ahmad, Aasim
Dawson, Angus
Singh, Jerome
Jesani, Amar
Upshur, Ross
author_sort Schopper, Doris
collection PubMed
description The Médecins Sans Frontières (MSF) ethics review board (ERB) has been solicited in an unprecedented way to provide advice and review research protocols in an ‘emergency’ mode during the recent Ebola epidemic. Twenty-seven Ebola-related study protocols were reviewed between March 2014 and August 2015, ranging from epidemiological research, to behavioural research, infectivity studies and clinical trials with investigational products at (very) early development stages. This article examines the MSF ERB’s experience addressing issues related to both the process of review and substantive ethical issues in this context. These topics include lack of policies regarding blood sample collection and use, and engaging communities regarding their storage and future use; exclusion of pregnant women from clinical and vaccine trials; and the difficulty of implementing timely and high-quality qualitative/anthropological research to consider potential upfront harms. Having noticed different standards across ethics committees (ECs), we propose that when multiple ethics reviews of clinical and vaccine trials are carried out during a public health emergency they should be accompanied by transparent communication between the ECs involved. The MSF ERB experience should trigger a broader discussion on the ‘optimal’ ethics review in an emergency outbreak and what enduring structural changes are needed to improve the ethics review process.
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spelling pubmed-54445632017-05-31 Research Ethics Governance in Times of Ebola Schopper, Doris Ravinetto, Raffaella Schwartz, Lisa Kamaara, Eunice Sheel, Sunita Segelid, Michael J. Ahmad, Aasim Dawson, Angus Singh, Jerome Jesani, Amar Upshur, Ross Public Health Ethics Original Articles The Médecins Sans Frontières (MSF) ethics review board (ERB) has been solicited in an unprecedented way to provide advice and review research protocols in an ‘emergency’ mode during the recent Ebola epidemic. Twenty-seven Ebola-related study protocols were reviewed between March 2014 and August 2015, ranging from epidemiological research, to behavioural research, infectivity studies and clinical trials with investigational products at (very) early development stages. This article examines the MSF ERB’s experience addressing issues related to both the process of review and substantive ethical issues in this context. These topics include lack of policies regarding blood sample collection and use, and engaging communities regarding their storage and future use; exclusion of pregnant women from clinical and vaccine trials; and the difficulty of implementing timely and high-quality qualitative/anthropological research to consider potential upfront harms. Having noticed different standards across ethics committees (ECs), we propose that when multiple ethics reviews of clinical and vaccine trials are carried out during a public health emergency they should be accompanied by transparent communication between the ECs involved. The MSF ERB experience should trigger a broader discussion on the ‘optimal’ ethics review in an emergency outbreak and what enduring structural changes are needed to improve the ethics review process. Oxford University Press 2017-04 2016-11-01 /pmc/articles/PMC5444563/ /pubmed/28567113 http://dx.doi.org/10.1093/phe/phw039 Text en © The Author 2016. Published by Oxford University Press. Available online at www.phe.oxfordjournals.org http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Original Articles
Schopper, Doris
Ravinetto, Raffaella
Schwartz, Lisa
Kamaara, Eunice
Sheel, Sunita
Segelid, Michael J.
Ahmad, Aasim
Dawson, Angus
Singh, Jerome
Jesani, Amar
Upshur, Ross
Research Ethics Governance in Times of Ebola
title Research Ethics Governance in Times of Ebola
title_full Research Ethics Governance in Times of Ebola
title_fullStr Research Ethics Governance in Times of Ebola
title_full_unstemmed Research Ethics Governance in Times of Ebola
title_short Research Ethics Governance in Times of Ebola
title_sort research ethics governance in times of ebola
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5444563/
https://www.ncbi.nlm.nih.gov/pubmed/28567113
http://dx.doi.org/10.1093/phe/phw039
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