Search

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.

The development of an HIV vaccine is one of the best hopes for the future of the HIV pandemic. HIV vaccine trials involve multiple disciplines and professions, including psychologists and other behavioural scientists. One of the most important aspects of HIV vaccine trials, like all clinical trials, is their ethical conduct. This article argues that many of the ethical issues in HIV vaccine trials have strong behavioural (including psychological) components and implications. The article goes on to examine three complex ethical issues, namely informed consent, harm monitoring, and adolescent participation, to illustrate the contribution that psychologists have to make to these ethical issues. First, it is argued that informed consent (IC), which is an essential ethical prerequisite for trials, relies on certain behavioural components as, for example, in determining how understanding can best be assessed. Also, behavioural research can add to the controversial debate about whether IC could be viewed as a culture-bound phenomenon, or whether first-person consent should be done away with in certain cultural contexts. Second, the issue of harms from trial participation is examined. We argue that assessing and minimising social and behavioural harms for participants — an essential demonstration of ongoing respect for participants — can be usefully informed by behavioural science assessment techniques and counselling. Third, the article addresses the role behavioural science can play in the sensitive ethical issue of adolescent participation in HIV vaccine trials. We argue that psychology can inform the complex assessment of whether adolescents are able to make informed and voluntary decisions about their participation in trials. The article concludes that the contribution of psychology to the ethical conduct of HIV vaccine trials may be seen as a novel and unique contribution of psychology to health research.

The main research question in this article is how access to information about HIV/AIDS and level of HIV/AIDS prevention related knowledge are distributed among disabled people, and whether level of knowledge predicts access to HIV/AIDS related services. A survey was carried out among a sample of 285 disabled people from three provinces in South Africa. Analyses of the data revealed that gender and level of education, together with geographical differences, are key predictors for access to information and knowledge about HIV/AIDS among disabled people. For male respondents number of information sources predicts access to voluntary counselling and testing services and HIV testing, while knowledge about prevention predicts access to Voluntary Counselling and Testing centres. Significant gender differences with regards to information, knowledge and access to services highlight the need for gender specific prevention strategies among disabled people.

Background South Africa is likely to be the first country in the world to host an adolescent HIV vaccine trial. Adolescents may be enrolled in late 2007. In the development and review of adolescent HIV vaccine trial protocols there are many complexities to consider, and much work to be done if these important trials are to become a reality. Discussion This article sets out essential requirements for the lawful conduct of adolescent research in South Africa including compliance with consent requirements, child protection laws, and processes for the ethical and regulatory approval of research. Summary This article outlines likely complexities for researchers and research ethics committees, including determining that trial interventions meet current risk standards for child research. Explicit recommendations are made for role-players in other jurisdictions who may also be planning such trials. This article concludes with concrete steps for implementing these important trials in South Africa and other jurisdictions, including planning for consent processes; delineating privacy rights; compiling information necessary for ethics committees to assess risks to child participants; training trial site staff to recognize when disclosures trig mandatory reporting response; networking among relevant ethics commitees; and lobbying the National Regulatory Authority for guidance.