Abstract
This national report on South Africa deals with issues such as informed consent, the protection of persons who are incapable of giving legal consent to clinical trials and research, and the function and composition of research ethics committees. The report discusses relevant South African common-law and constitutional provisions, and critically analyses national legislation and draft regulations which, for the first time in South Africa’s legal history, attempt to provide comprehensively for research-related issues. The report concludes that although the EU Directive on the Implementation of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use of 4 April 2001 (Directive 2001/20 EC) has thus far had very little direct effect on South Africa, there are many points of similarity between the provisions of the directive and the ethical and legal provisions which obtain in South Africa (as at April 2009).
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