An ethico-legal framework for the regulation of biobanks in South Africa

Abstract

The notion of biobanking in health research is not new. Despite this fact, ethico-legal frameworks have struggled to keep pace with the fast evolving scientific arena. Currently, biobanks function in a fragmented way and with regard to our South African situation, an ethico-legal lacuna exists in respect of guidance for the concerns that biobanks raise. Even though biobank research has now been incorporated into national ethical guidelines, its complexities call for the establishment of firm principles with regard to informed consent and secondary uses, ownership of materials, privacy and confidentiality, benefit sharing, and Material Transfer Agreement (MTA) requirements. In addition, the South African legislative framework remains silent with regard to its application, leaving the regulation of biobank research up to the researcher, sponsor and Research Ethics Committees (RECs). Using a normative and legal enquiry, this study aims to critically examine the ethical and legal requirements for biobank research in South Africa, with the intention of identifying gaps and areas for improvement towards the development of a framework that responds to and promotes South Africa’s needs, which includes the protection of populations, communities and individuals involved in biobank research, while at the same time, facilitating improvements to promote necessary research in the field. This study has resulted in the creation of a detailed MTA template and a draft set of Regulations for biobank research in South Africa, thus providing a starting point to the creation of a concrete ethico-legal framework in this regard.