Towards a data transfer agreement for the South African research community: The empowerment approach.

The idea of a data transfer agreement (DTA) template for the South African (SA) research community is receiving increasing attention. While developing such a DTA template is certainly a worthwhile project, questions regarding the project's practical execution should be addressed, including how to best operationalise the envisioned DTA template, and the content of the envisioned DTA template. It is proposed that an empowerment approach be followed in operationalising the envisioned DTA template, which is contrasted with the regulatory approach followed with the material transfer agreement that the Minister of Health promulgated in 2018. While the regulatory approach would entail government making the use of the envisioned DTA template compulsory regardless of the quality of such a template, the empowerment approach, by contrast, entails a focus on developing a high-quality, professionally drafted DTA template for the SA research community and making the use thereof a matter of own choice. Regarding the content of the envisioned DTA template, four hot-button content provisions are analysed, and it is argued that SA research institutions and researchers should be empowered to: (i) have clarity and legal certainty regarding their ownership of data, where relevant; (ii) be able to commercialise their research findings without unnecessary contractual constraints; (iii) avoid falling into the trap of unlawful benefit sharing with research participants; and (iv) be aware that their legal role as responsible parties, where relevant, cannot be contracted out via a DTA.

POPIA does indeed apply to health research: A response to Bronstein and Nyachowe.

Bronstein and Nyachowe recently argued that the conditions for the lawful processing of personal information, as provided in the Protection of Personal Information Act 4 of 2013 (POPIA), do not apply to health research in South Africa. This article critically analyses the authors' interpretation of section 3(2)(b) of POPIA and challenges two of its aspects.

Medicine and the Law.

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. Accordingly, consent forms should not include any provision that deals with the disposition of reproductive material after a fertility patient's death. Instead, to address the practical concern of keeping reproductive material cryopreserved without receiving payment, fertility clinics' storage agreements should use non-payment by fertility patients (or their successors in title) as the trigger event for the disposition of reproductive material. The importance of dealing with reproductive material in both its property rights dimension and its personality rights dimension is highlighted.

Is open-identity gamete donation lawful in South Africa?

South African (SA) gamete banks and gamete donation agencies do not offer open-identity donors, as it is generally believed that donor anonymity is a legal requirement in SA. However, analysis of SA statutory instruments and case law shows that this belief is mistaken, and that gamete donation in SA can be anywhere on the spectrum between anonymous and known. Accordingly, open-identity gamete donation would be lawful in SA and can be offered to the public by SA gamete banks and gamete donation agencies.

Artificial intelligence in healthcare: Proposals for policy development in South Africa.

Despite the tremendous promise offered by artificial intelligence (AI) for healthcare in South Africa, existing policy frameworks are inadequate for encouraging innovation in this field. Practical, concrete and solution-driven policy recommendations are needed to encourage the creation and use of AI systems. This article considers five distinct problematic issues which call for policy development: (i) outdated legislation; (ii) data and algorithmic bias; (iii) the impact on the healthcare workforce; (iv) the imposition of liability dilemma; and (v) a lack of innovation and development of AI systems for healthcare in South Africa. The adoption of a national policy framework that addresses these issues directly is imperative to ensure the uptake of AI development and deployment for healthcare in a safe, responsible and regulated manner.

COVID-19 and quarantine orders: A practical approach.

Quarantine is a very effective method for containing the spread of highly infectious diseases in large populations during a pandemic, but it is only effective if properly implemented. The co-operation and compliance of people entering quarantine are critical to its success. However, owing to the isolating and social distancing nature of quarantine, it often leads to extreme economic hardship and shortages in basic needs such as food, medicine, water and communication - and to the curtailment of certain universal social norms such as attending a parent's funeral. To escape these hardships, people often refuse to enter voluntary quarantine, or breach quarantine rules. In these circumstances, health authorities are obliged to act in the best interests of the public and obtain court orders to force some people into quarantine. In further extreme circumstances, when a national lockdown is ordered, non-compliance with quarantine measures may result in arrests and penalties. The scope of this article is limited to the period prior to and following such a lockdown, during which quarantine may still be vital for the containment of COVID-19. Because a quarantine order will deprive an individual of his or her freedom, this must be carefully balanced with the public interest. This article explains the legal and ethical considerations of this balancing exercise and provides practical guidance for obtaining quarantine orders.

Privacy rights of human research participants in South Africa must be taken seriously.

Letter by Thaldar and Townsend, following an article by the same authors (Thaldar D, Townsend B. Genomic research and privacy: A response to Staunton et al. S Afr Med J 2020;110(3):172-174. https://doi.org/10.7196/SAMJ.2020.v110i3.14431) and both commenting on an article by Staunton et al. (Staunton C, Adams R, Botes M, et al. Safeguarding the future of genomic research in South Africa: Broad consent and the Protection of Personal Information Act No. 4 of 2013. S Afr Med J 2019;109(7):468-470. https://doi.org/10.7196/SAMJ.2019.v109i7.14148); and response to article and letter by Staunton et al.

Genomic research and privacy: A response to Staunton et al.

The Protection of Personal Information Act No. 4 of 2013 (POPIA) promises a new dispensation of privacy protection for research participants in South Africa. In a recent article, Staunton et al. proposed that a purposive interpretation of POPIA would allow for the retention of the status quo of broad consent in the context of genomic research. In this response article, we analyse the argument presented by Staunton et al., and conclude that it fails to convince: firstly, because Staunton et al. do not present empirical data for their factual assumption that moving up the consent benchmark is likely to stymie research; secondly, because genomic research does not have a monopoly on the public interest, but shares it with the privacy rights of research participants; and thirdly, because POPIA was designed to promote the protection of privacy, not simply to preserve the status quo as found in existing policy instruments. In contrast to the position advocated by Staunton et al., we suggest that a purposive interpretation of POPIA is aligned with the plain meaning of the statute - namely that specific (not broad) consent is a prerequisite for research on genomic information.This article, which comments on an article by Staunton et al. (Staunton C, Adams R, Botes M, et al. Safeguarding the future of genomic research in South Africa: Broad consent and the Protection of Personal Information Act No. 4 of 2013. S Afr Med J 2019;109(7):468-470. https://doi.org/10.7196/SAMJ.2019.v109i7.14148), is followed by a letter by Thaldar and Townsend (Privacy rights of human research participants in South Africa must be taken seriously. S Afr Med J 2020;110(3):175-176. https://doi.org/10.7196/SAMJ.2020.v110i3.14450); and a response to the article and letter by Staunton et al. (S Afr Med J 2020;110(3):175-176. https://doi.org/10.7196/SAMJ.2020.v110i3.14450).

COVID-19 and quarantine orders: A practical approach

Quarantine is a very effective method for containing the spread of highly infectious diseases in large populations during a pandemic, but it is only effective if properly implemented. The co-operation and compliance of people entering quarantine are critical to its success. However, owing to the isolating and social distancing nature of quarantine, it often leads to extreme economic hardship and shortages in basic needs such as food, medicine, water and communication ­ and to the curtailment of certain universal social norms such as attending a parent's funeral. To escape these hardships, people often refuse to enter voluntary quarantine, or breach quarantine rules. In these circumstances, health authorities are obliged to act in the best interests of the public and obtain court orders to force some people into quarantine. In further extreme circumstances, when a national lockdown is ordered, non-compliance with quarantine measures may result in arrests and penalties. The scope of this article is limited to the period prior to and following such a lockdown, during which quarantine may still be vital for the containment of COVID-19. Because a quarantine order will deprive an individual of his or her freedom, this must be carefully balanced with the public interest. This article explains the legal and ethical considerations of this balancing exercise and provides practical guidance for obtaining quarantine orders

Posthumous conception: Recent legal developments in South Africa.

Posthumous conception - when a deceased person's gametes are used for procreative purposes - made its debut in South African (SA) courts in NC v Aevitas Fertility Clinic. A widow was granted the right to use her deceased husband's sperm for procreation. Against the background of legislative ambiguity, this case creates legal certainty that posthumous conception is legally permissible in SA - at least where deceased persons provided written consent that their gametes can be used by their surviving spouses or life partners after their death, and where there is no controversy about such consent.

CRISPR: Challenges to South African biotechnology law

Genome editing using newly discovered tools such as CRISPR-Cas9 offers the potential to modify the genetic make-up of plants, non-human animals and humans in exact ways. Such genetic modification can serve the purpose of correcting gene defects, and can enhance certain characteristics. Apart from reigniting old ethical debates, genome editing also poses a particular challenge to legal practitioners, as this new technology does not always fit into existing definitional moulds, and it lacks clear legal precedent. In this article, we identify the most salient areas of concern in the South African legal context