title: I'm positive, but i'm negative: Competing Voices in Informed Consent and Implications for HIV vaccine trials.
abstract: HIV vaccine trials (HVTs) are ethically complex, and sound informed consent processes should facilitate optimal decision-making for participants. This study aimed to explore representations of critical HVT-related concepts to enhance the consent process. Four focus group discussions were conducted with participants from key constituencies at a South African HVT site. Thematic analysis was employed to identify representations of key HVT-related concepts. The findings suggest that (potential) participants may negotiate multiple, competing versions of HVT-related concepts in a somewhat unrecognized process, which may have significant implications for the consent process. Stakeholders involved in consent and engagement activities at sites should be assisted to elicit, engage, and resolve competing representations of HVT-related concepts. More empirical research is needed to explore how such stakeholders address competing representations in their interactions with potential participants.
authors.affiliation: University of KwaZulu-Natal, Pietermaritzburg, South Africa rautenbach@ukzn.ac.za.
authors.forename: Clinton
authors.initials: C
authors.lastname: Rautenbach
authors.affiliation: University of KwaZulu-Natal, Pietermaritzburg, South Africa.
authors.forename: Graham
authors.initials: G
authors.lastname: Lindegger
authors.affiliation: University of KwaZulu-Natal, Pietermaritzburg, South Africa.
authors.forename: Catherine
authors.initials: C
authors.lastname: Slack
authors.affiliation: University of Cape Town, South Africa.
authors.forename: Melissa
authors.initials: M
authors.lastname: Wallace
authors.affiliation: University of Toronto, Ontario, Canada.
authors.forename: Peter
authors.initials: P
authors.lastname: Newman
mesh_terms: D016915:AIDS Vaccines; D000328:Adult; D001290:Attitude; D035843:Biomedical Research / Q000941:ethics*; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D035842:Research Subjects; D012111:Residence Characteristics
chemical_list: D016915:AIDS Vaccines
keywords: HIV vaccine trials; South Africa; culture; decision-making; empirical data; informed consent; mental models; research ethics
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