Ethical-Legal Challenges in Adolescent HIV Vaccine Trials (Research AND THE LAW‪)‬

South Africa is likely to enrol adolescents into a phase IIb proof of concept HIV vaccine trial in late 2007 or early 2008, which would make it the first country in the world to enrol adolescents into HIV vaccine trials. These healthy adolescents will be at high risk of HIV infection. They will have to undergo a general physical examination, answer questions about their personal HIV risk, be administered an experimental HIV vaccine or placebo via injection, have blood drawn for laboratory safety and immunogenicity testing, and have regular testing for HIV infection. (1) Many ethical/legal complexities exist, in part due to our fluctuating ethical-legal framework, the lack of legal guidance on issues such as adolescent privacy rights in research, and differing approaches towards child antonomy in child care and health legislation that enable children of a certain age to consent independently to medical treatment but not to research. Against this backdrop, in 2005 a member of the UCT Research Ethics Committee (REC) initiated a process of research into the minimum legal requirements that need to be met to ensure that adolescent HIV vaccine trials are lawful. As a result, a unique collaboration was established between an ethics and law research unit, (the HIV/AIDS Vaccines Ethics Group--HAVEG); members of the UCT REC, and researchers at the Desmond Tutu HIV Centre, Cape Town, and the Perinatal HIV Research Unit, Soweto. This collaboration resulted in the development of a roadmap of issues that ought to be addressed in order to promote the rights and welfare of adolescent participants in HIV vaccine trials, which was published in Biomedical Central: Medical Ethics in 2007.1 From November 2006 onwards, work began to apply these legal principles to a protocol for an adolescent HIV vaccine trial and its accompanying informed consent/assent forms. This article summarises the issues identified by this unique and on-going collaboration, published in an earlier article. (1)