Abstract
BackgroundSouth 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.DiscussionThis 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.SummaryThis 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.
Highlights
South Africa is likely to be the first country in the world to host an adolescent HIV vaccine trial
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
Adolescents have been involved in trials for vaccines to prevent sexually transmitted infections/diseases like Human Papilloma Virus (HPV) and Herpes Simplex Virus type-2, (HSV-2), both in the developed and the developing world [1,2]
Summary
The ethical-legal framework for child research in South Africa Currently South Africa does not have a comprehensive ethical-legal framework regulating research with children. In terms of current South African law, there is no guidance on who may provide consent for child participation in research if children lack this capacity themselves. The future Children's Act [14] in section 150 will oblige any person to identify children in need of care and protection (e.g. living in a child headed household, required to perform child labour, being maltreated, abused, or exploited) and to refer these to a social worker In terms of these laws, it is argued that HIV vaccine trial staff would have a legal duty to report abuse or ill-treatment disclosed by adolescent in a trial. It is likely that the MRC (2003) [19] guidelines drafted for HIV vaccine trials will need to be consulted which allow child participation provided risk standards, consent and scientific necessity requirements are met. Where the law is unclear, researchers should consult with their REC or get legal advice from a lawyer trained in research ethics and law
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