Navigating uncharted waters: biobanks and informational privacy in South Africa

Abstract

Abstract Biobanks (organised collections of human biological material and associated information stored for research purposes) are becoming invaluable to human health research. However, concerns have been voiced in the literature that POPIA – the new legislation that aims to protect personal information – may stymie the functioning of South African biobanks. The main reason for the concern is the dichotomy between specific consent (consent to use biological material and associated information for a specific research study) and broad consent (consent to use biological material and associated information for a variety of future research studies): While the current ethical and legal regulatory framework applicable to biobanks in South Africa requires only broad consent, POPIA appears to increase the benchmark to specific consent. A common model for building biobanks in South Africa is what we refer to as the ‘dual consent’ model – namely to obtain both specific consent for an initial research study, and broad consent for storage of material and associated information and the use thereof in future studies. We analyse the provisions of POPIA from a biobanking perspective, and conclude that biobanks that were built using the dual consent model would be able to use their collections of material and associated information for further new research studies, provided they comply with three conditions: (1) non-publication of the genetic information in an identifiable form; (2) the research must be in the public interest; and (3) sufficient guarantees must be in place to protect the research participants’ privacy. However, biobanks that were built using other models that did not include specific consent for the initial research study, would have to opt for either de-identification of their material and associated information, or obtain new specific consent from their research participants for a new research study.