title: Stakeholder perspectives on ethical challenges in HIV vaccine trials in South Africa.
abstract: There is little published literature on the ethical concerns of stakeholders in HIV vaccine trials. This study explored the ethical challenges identified by various stakeholders, through an open-ended, in-depth approach. While the few previous studies have been largely quantitative, respondents in this study had the opportunity to spontaneously identify the issues that they perceived to be of priority concern in the South African context. Stakeholders spontaneously identified the following as ethical priorities: informed consent, social harms, collaborative relationships between research stakeholders, the participation of children and adolescents, access to treatment for participants who become infected with HIV, physical harms, fair participant and community selection, confidentiality, benefits, and payment. While there is some speculation that research in developing countries poses special ethical challenges, overall no issues were identified that have not been anticipated in international guidance, literature and popular frameworks. However, the South African context affords a distinctive gloss to these expected issues; for example, respondents were concerned that the predominant selection of black participants may perpetuate racist practices of apartheid. Stakeholders should be aware of contextual factors impacting on the implementation of ethical principles. We make a series of recommendations for South African trials, including amendments to the ethical-legal framework and research policies, and, for further research.
authors.affiliation: University of KwaZulu-Natal. essack@ukzn.ac.za
authors.forename: Zaynab
authors.initials: Z
authors.lastname: Essack
authors.forename: Jennifer
authors.initials: J
authors.lastname: Koen
authors.forename: Nicola
authors.initials: N
authors.lastname: Barsdorf
authors.forename: Catherine
authors.initials: C
authors.lastname: Slack
authors.forename: Michael
authors.initials: M
authors.lastname: Quayle
authors.forename: Cedilia
authors.initials: C
authors.lastname: Milford
authors.forename: Graham
authors.initials: G
authors.lastname: Lindegger
authors.forename: Chitra
authors.initials: C
authors.lastname: Ranchod
authors.forename: Richard
authors.initials: R
authors.lastname: Mukuka
mesh_terms: D016915:AIDS Vaccines / Q000008:administration & dosage*; D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000941:ethics*; D003219:Confidentiality / Q000941:ethics; D003906:Developing Countries; D028744:Ethics Committees, Research; D032984:Ethics, Research; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006297:Health Services Accessibility / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D008297:Male; D018579:Patient Selection / Q000941:ethics; D011287:Prejudice; D012107:Research Design; D012108:Research Personnel / Q000191:economics / Q000941:ethics*; D035842:Research Subjects / Q000191:economics; D013019:South Africa; D011795:Surveys and Questionnaires; D055815:Young Adult
chemical_list: D016915:AIDS Vaccines