Despite the growing popularity of direct-to-consumer genetic testing, there is not a lot of literature on the topic in South Africa. The limited available research suggests that direct-to-consumer genetic testing is unregulated. However, Amy Gooden and I have investigated this topic and found that direct-to-consumer genetic testing is indeed regulated, and unusually so. The first step in the process – the collection of a saliva sample by consumers themselves – is unlawful on a plain reading of the National Health Act 61 of 2003 and the Regulations Relating to the Use of Human Biological Material. But this is only the beginning of our legal analysis, not the end! Read more here.
Tag: human biological material
If fertility patients pass away, what happens to their in vitro embryos?
South African fertility clinics often include a provision in their consent forms that deals with the disposition of reproductive material (gametes and embryos) after a fertility patient’s death. This practice is problematic as such a provision is not legally valid. If the clinic acts in pursuance of such a provision upon a fertility patient’s death, the fertility clinic may be committing a civil wrong and a crime. But what is the solution? Read more in my article in the South African Medical Journal.
The legal status of human biological material used for research
Whether human biological material (‘HBM’) in the research context is susceptible of ownership in South African law is contested, yet under-investigated. Previous literature on the subject barely touches the surface, and fails to provide in-depth, comprehensive legal analyses. This situation leads to legal uncertainty for local scientists, their international collaborators, and research ethics committees. In our latest article, published in South Africa’s most prestigious peer-reviewed law journal, Dr Bonginkosi Shozi and I dive deep into this topic — analysing both common law and statutory law — and conclude that HBM in the research context is indeed susceptible of ownership. We also consider the question of who owns HBM in various practical research-related scenarios. Importantly, we conclude that in all legally compliant scenarios HBM is owned by a research institution. There is no legally compliant scenario in which research participants can retain ownership of the HBM that they provide for research. We trust that our thorough analysis in this article will provide much-needed legal certainty to all involved in using HBM for research in South Africa.
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