Catherine Slack1, Ann Strode1, Theodore Fleischer2, Glenda Gray3 and Chitra Ranchod1
AIDS Vaccines Ethics Group, School of Psychology, University of
KwaZulu-Natal, Private Bag X01, Scottsville, 3209, Pietermaritzburg,
2International Research Ethics Network
for Southern Africa; Bioethics Centre, Department of Medicine, Groote
Schuur Hospital, Anzia Road, Observatory 7925, Cape Town, South Africa
AIDS Vaccine Division, Perinatal HIV Research Unit, Faculty of Health
Sciences, University of the Witwatersrand, PO Box 114, Diepkloof, 1864,
Gauteng, South Africa
BMC Medical Ethics 2007,
8:5. This is an Open Access article distributed under the terms of the Creative Commons Attribution License.
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 trig mandatory reporting response;
networking among relevant ethics commitees; and lobbying the National
Regulatory Authority for guidance.