Mishka Botes

Background. The SA DTA was updated to better serve the South African research community by providing clarity on exactly when – at what stage during research – institutions hold rights to the data they generate in collaborative research contexts where raw data are received and integrated with other data. SA DTA 1.1 introduces significant enhancements in data governance, focusing on the explicit definition and management of ‘inferential data’. Objectives. To introduce SA DTA 1.1 and demonstrate its practical application in real-world research contexts. Methods. Using a descriptive design, the study presents two practical case studies: one involving two universities and another a university and a pharmaceutical company. The first case focuses on identifying genetic markers for neurodegenerative diseases, while the second addresses genetic markers for chronic diseases. Results. In the first case study, the entity conducting the analysis generated inferential data independently, thereby gaining sole rights in such data. In the second case study, both collaborating entities contributed to the data analysis, leading to joint rights in the inferential data. These findings demonstrate the flexibility and clarity provided by SA DTA 1.1 in managing data ownership and intellectual property rights. Conclusion. SA DTA 1.1 significantly advances data governance by providing clear and adaptable guidelines for data rights in collaborative research. It supports ethical and efficient data sharing, protecting researchers’ interests and fostering global scientific innovation.

The transmission of cholera, a highly infectious disease, is closely linked to inadequate access to clean water and sanitation facilities, with resource-poor communities, including refugees, rural communities and temporary displacement camps particularly vulnerable to outbreaks. Any disruption in water and sanitation systems or a sudden surge in community size owing to displacement can spark a humanitarian and health crisis, elevating the risk of cholera transmission and possibly triggering a regional epidemic. Recently, Hammanskraal in Gauteng, South Africa, experienced such an epidemic. A multifaceted approach is essential to minimise fatalities and effectively manage healthcare services in such health emergencies. This approach includes early detection, rapid response to contain outbreaks, and the effective deployment of technical support, advocacy, resource mobilisation and partnerships at local, national, and international levels. This paper explores the responsibilities of individuals, healthcare workers, communities and governments in addressing epidemics. It also delves into the concept of collective responsibility with regard to climate change and cholera, as part of the multifaceted approach for cholera prevention and control. While economic development, equal access to safe drinking water, and adequate sanitation are necessary for cholera control, major challenges persist in achieving the fundamental right to a healthy environment in the long term. We also discuss these obstacles and conclude with practical suggestions and recommendations for future cholera prevention.

The prevalence of technology-embedded products, services, and cities, described colloquially as ‘smart’ technologies and ‘smart’ cities, has seen a spate of unprecedented growth in recent years. South Africa (SA) has not been left behind, with smartphones, smart watches, and smart voice-controlled virtual personal assistants such as Amazon’s Alexa now frequently used. But while these technologies hold great promise to revolutionise homes, offices and cities, their adoption poses challenges to individual and collective interests and wellbeing. After demonstrating the legal and ethical difficulties brought about by the introduction of these technologies, this article explores whether SA legislation is sufficiently robust to address these challenges. While the current legislative landscape addresses certain crucial difficulties – such as the safeguarding of personal data by the Protection of Personal Information Act No. 4 of 2013 (‘POPIA’) – it is suggested that the position regulating other aspects of smart technology adoption is, in large part, fragmented and ill-equipped to deal with some of the more pressing legal and ethical questions. Our contention is that, not dissimilar to the issues arising from artificial intelligence-based technological adoption, the extant legislative and regulatory frameworks do not go far enough in addressing the many concerns emerging from recent novel technological design, development, and deployment. Not only do smart technologies give rise to unique challenges, so does their deployment within the Global South and in South Africa, in particular. We suggest that appropriate and effective regulatory reform measures be undertaken in SA to provide better ethical guidance and policy prescriptions buttressed by rigorous regulatory oversight.

Many people who have reached the age of majority still qualify as financial dependents of their parents, and may be registered as dependents on their parents’ medical schemes. This poses a practical conundrum, because major persons enjoy complete autonomy over their bodies to choose healthcare services as they please, including informational determination. However, their sensitive health information may end up being disclosed in the accounts rendered to their parents, as main members of medical schemes, thereby breaching their informational privacy, medical confidentiality and possibly also damaging personal relationships. On the other hand, medical schemes must ensure that they strictly manage the business of their hospitalisation to ensure that they can adhere to their contractual and legal medical insurance obligations. Both major but financially dependent patients and medical schemes have good legal grounds to defend their respective positions. In this article, we will analyse and clarify the applicable legal and ethical grounds by considering medical confidentiality, the Protection of Personal Information Act, the Consumer Protection Act and the Medical Schemes Act and rules. We shall conclude with recommendations to accommodate the interests of both parties.

The idea of a data transfer agreement (DTA) template for the South African (SA) research community is receiving increasing attention. Whiledeveloping 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 anempowerment approach be followed in operationalising the envisioned DTA template, which is contrasted with the regulatory approachfollowed with the material transfer agreement that the Minister of Health promulgated in 2018. While the regulatory approach would entailgovernment making the use of the envisioned DTA template compulsory regardless of the quality of such a template, the empowermentapproach, by contrast, entails a focus on developing a high-quality, professionally drafted DTA template for the SA research community andmaking the use thereof a matter of own choice. Regarding the content of the envisioned DTA template, four hot-button content provisionsare analysed, and it is argued that SA research institutions and researchers should be empowered to: (i) have clarity and legal certaintyregarding their ownership of data, where relevant; (ii) be able to commercialise their research findings without unnecessary contractualconstraints; (iii) avoid falling into the trap of unlawful benefit sharing with research participants; and (iv) be aware that their legal role asresponsible parties, where relevant, cannot be contracted out via a DTA.

No known cure exists for COVID-19, and medical practitioners are exhausted and at their wits’ end trying to find treatments that prevent patients from ending up in hospital or intensive care, or even dying. A variety of treatments tried by medical practitioners include standard registered medicine, investigational or so-called experimental, unapproved or preapproved medicines, emergency or compassionate-use authorised medicine and pre-market approved medicine. However, the medicines that can be accessed via each of these categories are at different stages of efficacy testing and knowledge about adverse effects, dosages and risks. To obtain ethical and legal informed consent, medical practitioners must deal with a lot of medical uncertainty, and care must be taken to ensure that the patient understands the difference in risks they may be willing to take depending on the medicine’s stage of development. Often additional information is required to obtain ethical consent as opposed to legal consent. A purely legal approach to informed consent, especially when dealing with the medical uncertainties of health emergencies and pandemics, may lead to patients’ consent lacking in enough substance to be truly considered legal and ethical. Informed consent as respect for autonomy in this sense requires more than the patient’s explicit agreement or compliance with a certain treatment proposal. This article explains the difference in consent content attached to each different stage of a medicine’s development, especially considering the additional difficulties posed by obtaining truly informed consent during a pandemic with uncertain characteristics, treatment and solutions.