The role of law in the regulation of HIV-vaccine research in South Africa and Kenya

Abstract

Law is an important regulatory mechanism, particularly for creating an enabling research environment. However, the manner in which law addresses issues related to medical research, and HIV-vaccine research in particular, is at times inadequate and of great concern to the stakeholders involved in such research. The challenges for law as a regulatory mechanism in this regard are twofold: the complexity of issues related to HIV-vaccine research, and the apparent disconnection between the legal and ethical frameworks that are applied in the regulation of these issues. This article analyses the extent to which these challenges have been addressed in South Africa and Kenya. Especially, it highlights the lessons that can be drawn from the two countries in establishing a suitable ethical-legal framework for HIV-vaccine research.

Keywords:

• drug research
• ethics
• guidelines
• HIV/AIDS
• legal aspects
• legislation