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Ethical and scientific considerations on the establishment of a controlled human infection model for schistosomiasis in Uganda: report of a stakeholders' meeting held in Entebbe, Uganda.

ABSTRACT: Controlled human infection (CHI) models are gaining recognition as an approach to accelerating vaccine development, for use in both non-endemic and endemic populations: they can facilitate identification of the most promising candidate vaccines for further trials and advance understanding of protective immunity. Helminths present a continuing health burden in sub-Saharan Africa. Vaccine development for these complex organisms is particularly challenging, partly because protective responses are akin to mechanisms of allergy. A CHI model for Schistosoma mansoni (CHI-S) has been developed at Leiden University Medical Centre, the Netherlands. However, responses to schistosome infections, and candidate vaccines, are likely to be different among people from endemic settings compared to schistosome-naïve Dutch volunteers. Furthermore, among volunteers from endemic regions who have acquired immune responses through prior exposure, schistosome challenge can be used to define responses associated with clinical protection, and thus to guide vaccine development. To explore the possibility of establishing the CHI-S in Uganda, a Stakeholders' Meeting was held in Entebbe in 2017. Regulators, community members, researchers and policy-makers discussed implementation challenges and recommended preparatory steps: risk assessment; development of infrastructure and technical capacity to produce the infectious challenge material in Uganda; community engagement from Parliamentary to grass-roots level; pilot studies to establish approaches to assuring fully informed consent and true voluntariness, and strategies for selection of volunteers who can avoid natural infection during the 12-week CHI-S; the building of regulatory capacity; and the development of study protocols and a product dossier in close consultation with ethical and regulatory partners. It was recommended that, on completion, the protocol and product dossier be reviewed for approval in a joint meeting combining ethical, regulatory and environment management authorities. Most importantly, representatives of schistosomiasis-affected communities emphasised the urgent need for an effective vaccine and urged the research community not to delay in the development process.

SUBMITTER: Elliott AM

PROVIDER: S-EPMC6358001 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundDeveloping, implementing and evaluating worksite health promotion requires dealing with all stakeholders involved, such as employers, employees, occupational physicians, insurance companies, providers, labour unions and research and knowledge institutes. Although worksite health promotion is becoming more common, empirical research on ethical considerations of worksite health promotion is scarce.MethodsWe explored the views of stakeholders involved in worksite health promotion in focus group discussions and we described the ethical considerations that result from differences between these views. The focus group discussions were organised per stakeholder group. Data were analysed according to the constant comparison method.ResultsOur analyses show that although the definition of occupational health is the same for all stakeholders, namely 'being able to perform your job', there seem to be important differences in the views on what constitutes a risk factor to occupational health. According to the employees, risk factors to occupational health are prevailingly job-related. Labour unions agree with them, but other stakeholders, including the employer, particularly see employee-related issues such as lifestyle behaviour as risk factors to occupational health. The difference in definition of occupational health risk factors translates into the same categorisation of worksite health promotion; employee-related activities and work-related activities. The difference in conceptualisation of occupational health risk factors and worksite health promotion resonates in the way stakeholders understand 'responsibility' for lifestyle behaviour. Even though all stakeholders agree on whose responsibility lifestyle behaviour is, namely that of the employee, the meaning of 'responsibility' differs between employees, and employers. For employees, responsibility means autonomy, while for employers and other stakeholders, responsibility equals duty. This difference may in turn contribute to ambivalent relationships between stakeholders.ConclusionAll stakeholders, including employees, should be given a voice in developing, implementing and evaluating worksite health promotion. Moreover, since stakeholders agree on lifestyle being the responsibility of the employee, but disagree on what this responsibility means (duty versus autonomy), it is of utmost importance to examine the discourse of stakeholders. This way, ambivalence in relationships between stakeholders could be prevented.

Project description:BackgroundThe return of genetics and genomics research results has been a subject of ongoing global debate. Such feedback is ethically desirable to update participants on research findings particularly those deemed clinically significant. Although there is limited literature, debate continues in African on what constitutes appropriate practice regarding the return of results for genetics and genomics research. This study explored perspectives and ethical considerations of Ugandan genomics researchers regarding the return of genetics and genomics research results.MethodsThis was a qualitative study that employed in-depth interviews. Thirty participants were purposively selected based on their expertise as genomics researchers in Uganda. Data were analysed through content analysis along the main themes of the study using a comprehensive thematic matrix, to identify common patterns arising from the narratives. NVivo software 12 was used to support data analysis.ResultsThe return of genetics and genomics research results was generally acceptable to researchers, and some indicated that they had previously returned individual or aggregate results to participants and communities. The main reasons cited for sharing research results with participants included their clinical utility, actionability and overall benefit to society. Ethical considerations for appropriate return of results included a need for effective community engagement, genetic counselling prior to disclosure of the results, adequate informed consent, and proper assessment of the implications of, or consequences of returning of results. However, the approaches to return of results were perceived as unstandardized due to the lack of appropriate regulatory frameworks.ConclusionsThe return of genetic and genomic research results is generally acceptable to researchers despite the lack of appropriate regulatory frameworks. Ethical considerations for return of genetics and genomics research results are highly divergent, hence the need for national ethical guidelines to appropriately regulate the practice.

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Ethical and scientific considerations on the establishment of a controlled human infection model for schistosomiasis in Uganda: report of a stakeholders' meeting held in Entebbe, Uganda.

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