van Wyk Christa
Department of Jurisprudence, University of South Africa, Pretoria, South Africa.
Med Law. 2003;22(4):589-98.
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.
对未经个体受试者（本人）同意进行实验/研究的宪法禁令进行了调查。区分了治疗性研究和非治疗性研究。14岁的未成年人有能力独立同意接受医疗治疗（包括治疗性研究），但不能同意非治疗性研究。未成年人必须年满18岁才能同意非治疗性研究。只有在18岁以下未成年人表示同意、其参与研究必不可少且研究风险可忽略不计的情况下，才能获得代理同意，允许其参与非治疗性研究。由于艾滋病毒预防性疫苗试验固有的风险可能超过可忽略不计的程度，因此不得对18岁以下儿童进行此类试验。还对权利限制以及在解释《南非权利法案》时对外国和国际法的考虑进行了调查。
