HIV This Week

Slack C, Strode A, Fleischer T, Gray G, Ranchod C. Enrolling adolescents in HIV vaccine trials: Reflections on legal complexities from South Africa. BMC Med Ethics 2007;8:5.

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. 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.  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 trigger a mandatory reporting response; networking among relevant ethics committees; and lobbying the National Regulatory Authority for guidance.

Editors’ note: The reflections in this article have relevance beyond HIV vaccine trials to any trials involving adolescents. They have an evolving capacity to understand and consent to experimental products and interventions. In the case of HIV, enrolling adolescents in trials of novel biomedical HIV prevention products is particularly important in high incidence settings where adolescents are at very high risk of HIV exposure. They would be the primary beneficiaries for any public health programme involving a successful biomedical prevention product.

Numerous bodies from many countries, including governments, government regulatory departments, research organizations, medical professional bodies, and health care providers, have issued guidance or legislation on the ethical conduct of clinical trials. It is possible to trace the development of current guidelines back to the post-World War II Nuremburg war crimes trials, more specifically the « Doctors’ Trial. » From that trial emerged the Nuremburg Code, which set out basic principles to be observed when conducting research involving human subjects and which subsequently formed the basis for comprehensive international guidelines on medical research, such as the Declaration of Helsinki. Most recently, the Council for International Organizations and Medical Sciences (CIOMS) produced detailed guidelines (originally published in 1993 and updated in 2002) on the implementation of the principles outlined in the Declaration of Helsinki. The CIOMS guidelines set in an appropriate context the challenges of present-day clinical research, by addressing complex issues including HIV research, availability of study treatments after a study ends, women as research subjects, safeguarding confidentiality, compensation for adverse events, as well guidelines on consent.

Editors’ note: UNAIDS and WHO have just completed updating of the popular 2000 UNAIDS guidance document Ethical considerations in HIV preventive vaccine research with the assistance of an expert panel composed of members from Australia, Brazil, Great Britain, India, Israel, Nigeria, South Africa, Switzerland, Thailand and the USA. Entitled Ethical considerations in biomedical HIV prevention trials: UNAIDS/WHO guidance document, it is consistent with CIOMS and other international research ethics guidelines. Containing 19 guidance points, it will be translated initially into French, Portuguese, Spanish and Russian.