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      Power, fairness and trust: understanding and engaging with vaccine trial participants and communities in the setting up the EBOVAC-Salone vaccine trial in Sierra Leone

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          Abstract

          Background

          This paper discusses the establishment of a clinical trial of an Ebola vaccine candidate in Kambia District, Northern Sierra Leone during the epidemic, and analyses the role of social science research in ensuring that lessons from the socio-political context, the recent experience of the Ebola outbreak, and learning from previous clinical trials were incorporated in the development of community engagement strategies. The paper aims to provide a case study of an integrated social science and communications system in the start-up phase of the clinical trial.

          Methods

          The paper is based on qualitative research methods including ethnographic observation, interviews with trial participants and key stakeholder interviews.

          Results

          Through the case study of EBOVAC Salone, the paper suggests ways in which research can be used to inform communication strategies before and during the setting up of the trial. It explores notions of power, fairness and trust emerging from analysis of the Sierra Leonean context and through ethnographic research, to reflect on three situations in which social scientists and community liaison officers worked together to ensure successful community engagement. Firstly, a section on “power” considers the pitfalls of considering communities as homogeneous and shows the importance of understanding intra-community power dynamics when engaging communities. Secondly, a section on “fairness” shows how local understandings of what is fair can help inform the design of volunteer recruitment strategies. Finally, a section on “trust” highlights how historically rooted rumours can be effectively addressed through active dialogue rather than through an approach focused on correcting misinformation.

          Conclusion

          The paper firstly emphasises the value of social science in the setting up of clinical trials, in terms of providing an in depth understanding of context and social dynamics. Secondly, the paper suggests the importance of a close collaboration between research and community engagement to effectively confront political and social dynamics, especially in the context of an epidemic.

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          Most cited references38

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          What makes clinical research in developing countries ethical? The benchmarks of ethical research.

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            Understanding of informed consent in a low-income setting: three case studies from the Kenyan Coast.

            In our research unit on the Kenyan Coast, parents sign consent for over 4000 children to be involved in research activities every year. Children are recruited into studies ranging from purely observational research to the testing of new procedures and drugs. Thousands more community members consent verbally or in writing to the interviews and sometimes invasive procedures required in community-based research. Although every study and consent form is reviewed in advance by independent national and international committees, the views and understanding of the 'subjects' of these activities had not been documented before this study. In this paper, we focus on participant understanding of one field-based and two hospital-based studies, all of which involve blood sampling. The findings highlight a range of inter-related issues for consideration in the study setting and beyond, including conceptual and linguistic barriers to communicating effectively about research, the critical and complex role of communicators (fieldworkers and nurses) in consent procedures, features of research unit-community relations which impact on these processes, and the special sensitivity of certain issues such as blood sampling. These themes and emerging recommendations are expected to be relevant to, and would benefit from, experiences and insights of researchers working elsewhere.
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              Trust and informed consent: insights from community members on the Kenyan coast.

              Trust is an important theme running through the literature on the ethics of biomedical research, but it is rarely given centre stage. In this paper, we present data gathered from a study aimed at exploring community views regarding the informed consent processes carried out by a large research centre on the Kenyan Coast. The findings point to the centrality of trust and elements of mistrust in general community views, in parents' (mis)understanding of studies they consent their children to be involved in, in refusals and concerns, and in community members' views about whether informed consent is a relevant and practical model to follow. Tentative ideas on how trust and a healthy mistrust might be balanced highlight the importance of strengthening communication surrounding basic health care as well as research, and of fostering 'an inner generated ethic of service'. The latter is particularly fundamental, but cannot be built and regulated through the laws, policies and guidelines that currently govern biomedical research practice.
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                Author and article information

                Contributors
                l.enria@bath.ac.uk
                shelley.lees@lshtm.ac.uk
                elizabeth.smout@lsthm.ac.uk
                thomas.mooney@lshtm.ac.uk
                fangusten@gmail.com
                bailahleigh@yahoo.co.uk
                brian.greenwood@lshtm.ac.uk
                deborah.watson-jones@lshtm.ac.uk
                heidi.larson@lshtm.ac.uk
                Journal
                BMC Public Health
                BMC Public Health
                BMC Public Health
                BioMed Central (London )
                1471-2458
                8 November 2016
                8 November 2016
                2016
                : 16
                : 1140
                Affiliations
                [1 ]University of Bath, Claverton Down Road, Bath, BA2 7AY UK
                [2 ]London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT UK
                [3 ]College of Medicine and Allied Health Sciences (COMAHS), University of Sierra Leone, Fourah Bay College Campus, Freetown, Sierra Leone
                [4 ]Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza, Tanzania
                Author information
                http://orcid.org/0000-0002-6336-6531
                Article
                3799
                10.1186/s12889-016-3799-x
                5100248
                27821112
                77deab7b-be11-4673-87ba-f101eb4b2613
                © The Author(s). 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 17 June 2016
                : 1 November 2016
                Funding
                Funded by: Innovative Medicines Initiative
                Award ID: 115854
                Award Recipient :
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2016

                Public health
                vaccine trials,ebola,anthropology,sierra leone,community engagement
                Public health
                vaccine trials, ebola, anthropology, sierra leone, community engagement

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