title: The participation of minors in preventive HIV research trials in South Africa: legal and human rights considerations.
abstract: The constitutional prohibition of experimentation/research without the individual subject's (own) consent is investigated. A distinction is drawn between therapeutic and non-therapeutic research. A minor of 14 is competent to consent independently to medical treatment (which would include therapeutic research), but not to non-therapeutic research. A minor must be at least 18 years to be able to do so. Proxy consent can be secured for the participation of minors under 18 in non-therapeutic research only if they assent, if their participation in the research is indispensable and the research carries no more than negligible risk. Since the risks inherent in HIV preventive vaccine trials may carry more than negligible risk, these trials may not be carried out on children under 18. The limitation of rights and the consideration of foreign and international law in the interpretation of the South African Bill of Rights are investigated.
authors.affiliation: Department of Jurisprudence, University of South Africa, Pretoria, South Africa.
authors.forename: Christa
authors.initials: C
authors.lastname: van Wyk
mesh_terms: D016915:AIDS Vaccines / Q000494:pharmacology / Q000627:therapeutic use; D000293:Adolescent; D000367:Age Factors; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D015658:HIV Infections / Q000188:drug therapy / Q000453:epidemiology / Q000517:prevention & control*; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D006806:Human Rights / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent; D033281:Nontherapeutic Human Experimentation / Q000331:legislation & jurisprudence; D035842:Research Subjects / Q000331:legislation & jurisprudence; D013019:South Africa / Q000453:epidemiology; D036302:Therapeutic Human Experimentation / Q000331:legislation & jurisprudence
chemical_list: D016915:AIDS Vaccines