HIV vaccine research - South Africa's ethical-legal framework and its ability to promote the welfare of trial participants

ABSTRACT

An effective ethical-legal framework for the conduct of research is critical. We describe five essential components of such a system; review the extent to which these components have been realised in South Africa; present brief implications for the ethical conduct of clinical trials of HIV vaccines in South Africa and make recommendations. The components of an effective ethical-legal system that we propose are the existence of scientific ethical and policy-making structures that regulate research; research ethics committees (RECs) that ethically review research; national ethical guidelines and standards; laws protecting research participants; and mechanisms to enforce and monitor legal rights and ethical standards. We conclude that the ethical-legal framework has; for the most part; the necessary institutions; and certain necessary guidelines but does not have many of the laws needed to protect and promote the rights of persons participating in research; including HIV vaccine trials. Recommendations made include advocacy measures to finalise and implement legislation; development of regulations; analysis and comparison of ethical guidelines; and the development of measures to monitor ethical-legal rights at trial sites