Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa.

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 committees; and lobbying the National Regulatory Authority for guidance.

Research ethics capacity building in Sub-Saharan Africa: a review of NIH Fogarty-funded programs 2000­2012.

The last fifteen years have witnessed a significant increase in investment in research ethics capacity development throughout the world. We examine nine research ethics training programs that are focused on Sub-Saharan Africa and supported by the US National Institutes of Health. We collected data from grants awards' documents and annual reports supplemented by questionnaires completed by the training program directors. Together, these programs provided long-term training in research ethics to 275 African professionals, strengthened research ethics committees in 19 countries in Sub-Saharan Africa, and created research ethics curricula at many institutions and bioethics centers within Africa. Trainees' leadership resulted in new national systems and policies on research ethics, human tissue storage and export, and methods of monitoring compliance with research ethics guidelines. Training programs adapted to challenges that arose due to varied trainees' background knowledge in ethics, duration of time available for training, spoken and written English language skills, administrative obstacles, and the need to sustain post-training research ethics activities. Our report showcases the development of awareness of research ethics and building/strengthening of basic research ethics infrastructure in Sub-Saharan Africa. Nevertheless, the increasing amount and complexity of health research being conducted in Sub-Saharan Africa suggests the need for continued investment in research ethics capacity development in this region. This paper is part of a collection of papers analyzing the Fogarty International Center's International Research Ethics Education and Curriculum Development program.

Improving resource allocation decisions for health and HIV programmes in South Africa: Bioethical, cost-effectiveness and health diplomacy considerations.

The escalating expenditure on patients with HIV/AIDS within an inadequately funded public health system is tending towards crowding out care for patients with non-HIV illnesses. Priority-setting decisions are thus required and should increasingly be based on an explicit, transparent and accountable process to facilitate sustainability. South Africa's public health system is eroding, even though the government has received extensive donor financing for specific conditions, such as HIV/AIDS. The South African government's 2007 HIV plan anticipated costs exceeding 20% of the annual health budget with a strong focus on treatment interventions, while the recently announced 2012-2016 National Strategic HIV plan could cost up to US$16 billion. Conversely, the total non-HIV health budget has remained static in recent years, effectively reducing the supply of health care for other diseases. While the South African government cannot meet all demands for health care simultaneously, health funders should attempt to allocate health resources in a fair, efficient, transparent and accountable manner, in order to ensure that publicly funded health care is delivered in a reasonable and non-discriminatory fashion. We recommend a process for resource allocation that includes ethical, economic, legal and policy considerations. This process, adapted for use by South Africa's policy-makers, could bring health, political, economic and ethical gains, whilst allaying a social crisis as mounting treatment commitments generated by HIV have the potential to overwhelm the health system.