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Doctoral Degrees (HIV Medicine)

Permanent URI for this collectionhttps://hdl.handle.net/10413/7024

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    Exploring the ancillary-care experiences of stakeholders in South African HIV vaccine trials.
    (2015) Slack, Catherine May.; Lindegger, Graham Charles.
    A controversial debate in research ethics comprises the responsibilities of sponsors and researchers to address participants’ medical needs in low-resource settings when this would not service the scientific objectives of the research, nor keep participants safe – their so-called ‘ancillary-care’ responsibilities – particularly when responses might be costly or demanding. The ancillary-care debate partially emerged out of the field of HIV vaccine trials. There has been surprisingly little effort to systematically explore the practices and perspectives of researchers (and other key role-players) regarding ancillary care in such trials. This qualitative study aimed to explore the experiences of key stakeholders involved in HIV vaccine trials in South Africa, specifically: their practices, how such practices are made sense of or understood, and contemporary concerns and complexities. It was funded by the Wellcome Trust Biomedical Ethics Program (087429/Z/08/Z). Semi-structured interviews were conducted with representatives of the coordinating network as well as Research Ethics Committees, Community Advisory Boards and research staff at five sites in the country implementing two HIV vaccine trial protocols. Key documents were obtained, including protocols, informed consent forms and supporting documentation. The study obtained necessary ethical approvals (UKZN BREC BE 241/09) and written consent was provided for study participation. Data was analyzed using Thematic Analysis to develop themes that captured meanings attributed by interviewees to their practices and experiences. Five master themes were developed namely Reciprocating, Engaging, Benefitting; as well as Reconciling, Privileging, Line-drawing, and Partnering. These master themes, and sub-themes, are discussed in terms of the ancillary-care literature. The study sets out implications of stakeholders’ ancillary-care experiences for leading accounts of ancillary care, as well as for current ethical guidelines. Recommendations are made to refine guidance so it is more responsive to the concerns and complexities experienced by stakeholders in the field. Recommendations are made to strengthen the practices of core stakeholders. It is hoped that through refined guidance and strengthened practices this study can contribute to the ethical rigor with which such trials are implemented.