The participation of children in HIV/AIDS clinicals trials : ethical and legal considerations

Abstract

This dissertation examines the legal position relating to the participation of children in research, especially in HIV preventive clinical research in South Africa. HIV/AIDS presents a real threat to humanity and particularly to the welfare of children. The participation of children in this type of trials is therefore vital. Children, as vulnerable participants, must also be protected from harm resulting from research. The study also considers the nature of HIV preventive clinical research, pointing to the inconsistencies in the legislation governing children’s participation in HIV preventive vaccine trials. The dissertation concludes that the question of the participation of children in HIV preventive clinical research poses many challenges, as the position in the South African law and relevant ethical guidelines are inconsistent and contradictory. The study recommends in the final instance that the relevant statutory provisions and ethical guidelines be harmonised in order to clear up the inconsistencies.