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.

中文翻译：

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探索未知水域：南非的生物库和信息隐私

摘要 生物库（为研究目的而存储的有组织的人类生物材料和相关信息的集合）对人类健康研究变得非常宝贵。然而，文献中有人担心 POPIA——旨在保护个人信息的新立法——可能会阻碍南非生物库的运作。引起关注的主要原因是特定同意（同意将生物材料和相关信息用于特定研究）和广泛同意（同意将生物材料和相关信息用于各种未来研究）之间的二分法：虽然当前适用于南非生物库的道德和法律监管框架只需要广泛的同意，POPIA 似乎将基准提高到特定的同意。在南非建立生物样本库的一种常见模式是我们所说的“双重同意”模式——即获得初步研究的特定同意，以及材料和相关信息的存储及其未来使用的广泛同意学习。我们从生物样本库的角度分析了 POPIA 的规定，并得出结论，使用双重同意模型建立的生物样本库将能够使用他们收集的材料和相关信息进行进一步的新研究，前提是它们符合以下三个条件：（1 ) 不以可识别的形式公开遗传信息；(2) 研究必须符合公共利益；(3) 必须有足够的保障来保护研究参与者的隐私。然而，