12
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Research Ethics Governance in Times of Ebola

      research-article

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          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.

          Related collections

          Most cited references26

          • Record: found
          • Abstract: not found
          • Article: not found

          Ebola virus disease in West Africa--clinical manifestations and management.

            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            What obstetrician-gynecologists should know about Ebola: a perspective from the Centers for Disease Control and Prevention.

            West Africa is currently in the midst of the largest Ebola outbreak in history. Although there have been no Ebola virus disease cases identified in the United States, two U.S. health care workers with Ebola virus disease were medically evacuated from Liberia to the United States in early August 2014. The Centers for Disease Control and Prevention has been working closely with other U.S. government agencies and international and nongovernmental partners for several months to respond to this global crisis. Limited evidence suggests that pregnant women are at increased risk for severe illness and death when infected with Ebola virus, but there is no evidence to suggest that pregnant women are more susceptible to Ebola virus disease. In addition, pregnant women with Ebola virus disease appear to be at an increased risk for spontaneous abortion and pregnancy-associated hemorrhage. Neonates born to mothers with Ebola virus disease have not survived. Although it is very unlikely that obstetrician-gynecologists (ob-gyns) in the United States will diagnose or treat a patient with Ebola virus disease, it is important that all health care providers are prepared to evaluate and care for these patients. Specifically, U.S. health care providers, including ob-gyns, should ask patients about recent travel and should know the signs and symptoms of Ebola virus disease and what to do if assessing a patient with compatible illness. This article provides general background information on Ebola and specifically addresses what is known about Ebola virus disease in pregnancy and the implications for practicing ob-gyns in the United States.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Ebola viral disease outbreak--West Africa, 2014.

              On March 21, 2014, the Guinea Ministry of Health reported the outbreak of an illness characterized by fever, severe diarrhea, vomiting, and a high case-fatality rate (59%) among 49 persons. Specimens from 15 of 20 persons tested at Institut Pasteur in Lyon, France, were positive for an Ebola virus by polymerase chain reaction. Viral sequencing identified Ebola virus (species Zaïre ebolavirus), one of five viruses in the genus Ebolavirus, as the cause. Cases of Ebola viral disease (EVD) were initially reported in three southeastern districts (Gueckedou, Macenta, and Kissidougou) of Guinea and in the capital city of Conakry. By March 30, cases had been reported in Foya district in neighboring Liberia (1), and in May, the first cases identified in Sierra Leone were reported. As of June 18, the outbreak was the largest EVD outbreak ever documented, with a combined total of 528 cases (including laboratory-confirmed, probable, and suspected cases) and 337 deaths (case-fatality rate = 64%) reported in the three countries. The largest previous outbreak occurred in Uganda during 2000-2001, when 425 cases were reported with 224 deaths (case-fatality rate = 53%). The current outbreak also represents the first outbreak of EVD in West Africa (a single case caused by Taï Forest virus was reported in Côte d'Ivoire in 1994 [3]) and marks the first time that Ebola virus transmission has been reported in a capital city.
                Bookmark

                Author and article information

                Journal
                Public Health Ethics
                Public Health Ethics
                phe
                Public Health Ethics
                Oxford University Press
                1754-9973
                1754-9981
                April 2017
                01 November 2016
                01 November 2016
                : 10
                : 1
                : 49-61
                Affiliations
                Medical Faculty, University of Geneva, Center for Education and Research in Humanitarian Action (CERAH)
                Department of Clinical Sciences, Institute of Tropical Medicine, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven
                Faculty of Health Sciences, McMaster University
                Department of Philosophy, Religion and Theology, Moi University
                Independent Researcher in Global Health and Bioethics,Pune
                Centre for Human Bioethics, Monash University
                The Kidney Centre, Pakistan, Aga Khan University
                Centre for Values, Ethics & the Law in Medicine, School of Public Health, University of Sydney
                Centre for the AIDS Programme of Research in South Africa (CAPRISA)
                Anusandhan Trust
                Department of Family and Community Medicine and Dalla Lana School of Public Health, University of Toronto
                Author notes
                [* ]Corresponding author: Doris Schopper, Bahnhofstrasse 134, 8620 Wetzikon. Tel.: ++4144 9312018; Fax: ++4144 9312015; Email: Doris.Schopper@ 123456unige.ch
                Article
                phw039
                10.1093/phe/phw039
                5444563
                28567113
                4286815b-01bc-489a-9a6d-b703c4340496
                © The Author 2016. Published by Oxford University Press. Available online at www.phe.oxfordjournals.org

                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

                History
                Page count
                Pages: 13
                Categories
                Original Articles

                Public health
                Public health

                Comments

                Comment on this article