The parameters of the current legal framework for health research: Forms of health research which are regulated and obligations imposed on researchers

Abstract

On 1 March 2012, the South African Minister of Health operationalised section 71 of the National Health Act (NHA), ushering in a new phase of research regulation. When read with sections 1, 11 and 16 of the NHA, section 71 describes the legal norms for undertaking various forms of health research in South Africa. Three key terms used in the NHA now set the parameters of the legal framework for regulating health research: ‘health research’ (section 1), ‘research or experimentation on a living person’ (section 71), and the provision of a ‘health service for research or experimental purposes’ (section 11). Importantly, these three concepts delineate (i) what forms of health research are regulated by the legal framework, and (ii) the nature of the obligations placed on health researchers and others. Researchers and members of research ethics committees need to be aware that the NHA assigns different legal obligations to different forms of health research. This article describes the parameters of the new legal framework and the obligations that flow from each of the three categories of health research. It shows how the restrictions the framework imposes are not evenly spread across all forms of research, and concludes by identifying some of its strengths, weaknesses and anomalies. It further suggests that more conceptual elaboration is required to ascertain whether the differences are coherent
and justified.