In the history of public health vaccines have proven to be among the most effective disease prevention tools. It is clear that in the fight against HIV that new and powerful preventive technology such as a vaccine is badly needed. Ethically, however the processes of developing a vaccine against HIV have been distinctly different from that of any previous pharmaceutical products. HIV vaccine trials can be ethically complex for a number of reasons. In 2004 the HIV I AIDS Vaccine Ethics Group undertook a research initiative that aimed to collect data from various South African stake holders of HIV vaccine trials to ascertain what they perceived as the ethical challenges related to HIV vaccine trials. A quantitative content analysis on the data from 31 semistructured interviews revealed that the ethical issue listed spontaneously by most of the respondents was that of informed consent. Further probing and discussion on informed consent identified a number of sub issues which the respondents thought would pose important challenges to HIV vaccine trials in the South African context. This study undertook to do a more in-depth qualitative analysis of the data to ascertain whether the challenges and concerns the stakeholders have are consistent with or different to those already identified in the literature and ethical guidelines on informed consent in medical research. What variables may be impacting on the position stakeholders take was also of interest. Results indicated that many concerns relating to the substantive and procedural elements of informed consent were consistent with those debated in the literature. These issues related to first person consent, the voluntariness of participants' consent, practicing cultural sensitivity, dealing with language issues, promoting and assessing understanding of material disclosed, issues around the vulnerability of .. participants, children and adolescents' capacity to consent and the role of the media. More specific to the South African context, stakeholders were concerned about the legal framework under which the trials take place, the general lack of education and training about HIV vaccine trials, a lack of communication and coordination between stakeholder groups, and the historical influences of apartheid on black South African participants' capacity to consent. The main variables that appeared to impact on the position stakeholders took related to the role the stakeholders play within the trials, the philosophical position underpinning their ethical viewpoints, stakeholders' understanding of vulnerability and capacity to consent, and how they view the universality or relativity of ethical issues.

Thesis (M. Clinical Psychology) - University of KwaZulu-Natal, Pietermaritzburg, 2008.