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Private medical aids are essentially non-profit organisations that aim to fund the delivery of speedy treatment, and should protect members from unexpected, out-of-pocket expenses for medical care. However, although the latest statistics show that 16.2% of individuals in South Africa (SA) are members of medical aid schemes, making the promise of private healthcare accessible to a small percentage of the population, they are not without their own unique set of challenges. The restrictions that exist within the private sector have a direct bearing on the types of healthcare services patients can access, which in turn impacts on the fundamental right to access healthcare. Using a recent High Court decision, this article seeks to explore justice in the provision of healthcare services, specifically within the private sector in SA. [ABSTRACT FROM AUTHOR]

While open science gains prominence in South Africa with the encouragement of open data sharing for research purposes, there are stricter laws and regulations around privacy - and specifically the use, management and transfer of personal information - to consider. The Protection of Personal Information Act No. 4 of 2013 (POPIA), which came into effect in 2021, established stringent requirements for the processing of personal information and has changed the regulatory landscape for the transfer of personal information across South African borders. At the same time, draft national policies on open science encourage wide accessibility to data and open data sharing in line with international best practice. As a result, the operation of research ethics committees (RECs) in South Africa is affected by the conflicting demands of the shift towards open science on the one hand, and the stricter laws protecting participants' personal information and the transfer thereof, on the other. This article explores the continuing evolving role of RECs in the era of open data and recommends the development of a data transfer agreement (DTA) for the ethical management of personal health information, considering the challenges that RECs encounter, which centres predominantly on privacy, data sharing and access concerns following advances in genetic and genomic research and biobanking. [ABSTRACT FROM AUTHOR]

Globally, there has been a move toward 'open science' that includes the sharing of health data for research. The importance of data sharing for research is generally acknowledged, but this must only be done with legal and ethical procedures and protections in place. The use and sharing of health data for research in South Africa has changed with the coming into force of the Protection of Personal Information Act (POPIA). POPIA should ensure greater transparency and accountability in the use of personal information. POPIA, however, adopts a principle-based approach to the regulation of personal information, and there is a lack of clarity and uncertainty in the application of some of these principles to the use of health data for research. POPIA provides for sector-specific responses through the development of codes of conduct. In this article, we discuss the need for a code of conduct for health research, and an approach that could be adopted in its development. [ABSTRACT FROM AUTHOR]

Realisation of the value and the commercialisation potential of data is gaining exponential momentum. The combination of historical data exploitations and the use of technologies that allow for the triangulation of data results in the collection, storage, and processing of massive amounts of data require diligent data management, including adherence to privacy and other laws, both nationally and internationally. The intrinsic value of scientific data, especially in genomics, becomes apparent when data are shared, often in collaboration with international partners, and compiled into big data sets that are subsequently used for benefit, including commercial benefit. The purpose of this article is to explore the commercialisation of data in South Africa against the backdrop of the legal framework governing the protection of personal information, confidentiality and privacy, with a specific focus on genetic and genomic information. Related issues, such as the collection and sharing of data, ownership of data and challenges about informed consent are also considered. After a brief evaluation of the African regulatory landscape relating to the protection of personal information, the article concludes with a few recommendations aimed at improving the status quo and sensitising the South African public as to the value of their data and personal information, as well as the potential uses and abuses to which their personal information may be subjected. [ABSTRACT FROM AUTHOR]

Africa, and sub-Saharan Africa in particular, is one of the last continents to have recorded COVID-19 cases, and is expected to be severely impacted by the virus. The lack of intensive care capacity and under-resourced public healthcare settings in many African countries, coupled with high levels of poverty and poor access to healthcare services, applies to some extent to South Africa (SA). The SA government's swift and decisive response to address COVID-19 in March 2020, although praised by many, is increasingly being criticised for its disproportionate, contradictory and harsh consequences, not to mention a range of legal challenges that have followed since the introduction of lockdown measures in terms of the Disaster Management Act. This article examines some of the ethical and legal issues relating to the government's approach to COVID-19. [ABSTRACT FROM AUTHOR]

The existing ethico-legal regulation of adolescent children's participation in health research in South Africa is currently unclear. The article interrogates the existing framework governing children's consent to research participation, with specific emphasis on discrepancies in consent norms in law and ethical guidelines. Against the backdrop of the constitutional directive that requires that a child's best interests are of paramount importance in every matter concerning the child, the article assesses whether sufficient consideration is given to children's evolving maturity and capacities when consent to their participation in health research is sought. The article provides specific recommendations and proposes a legislative change to consent provisions in the National Health Act 61 of 2003 in order to address the existing lacunae and to align the framework with constitutional imperatives and international fundamental rights considerations., (© 2022 The Authors. Developing World Bioethics published by John Wiley & Sons Ltd.)

Background: Adolescents are a unique population with significant unmet health needs. They are often excluded from research that may benefit them as they are perceived as vulnerable and needing protection from research participation. For Research Ethics Committees, conflicting positions in statutes, regulations and ethical guidelines about who provides informed consent for adolescent involvement in health research can be a significant barrier to approving adolescent research. For researchers, the requirement for parental/guardian proxy consent or prolonged approval processes may potentially result in the exclusion of those adolescents most vulnerable and at risk, particularly if issues such as gender-based violence, gender identity, sexuality and sexual practices are in question., Objectives: To describe the challenges to adolescent research and suggest strategies to address these., Method: We consider the legal and ethical framework in South Africa regarding the consenting age for adolescents in research, outline the challenges and, using examples of best practices, suggest strategies to address the current conundrum., Results: We suggest three principles to guide Research Ethics Committees on their approach to reviewing health research involving adolescents. Strategies to develop ethically acceptable approaches to adolescent research and consent processes are described, which include community involvement. We elaborate on examples of nuanced approaches to adolescent research., Conclusion: The inclusion of adolescents in research is critical in informing appropriate and effective health services for this vulnerable population, whilst providing an opportunity to link them into care and services where relevant., Competing Interests: The authors declare that they have no financial or personal relationships that may have inappropriately influenced them in writing this article., (© 2022. The Authors.)

Genomic research and biobanking has undergone exponential growth in Africa and at the heart of this research is the sharing of biospecimens and associated clinical data amongst researchers in Africa and across the world. While this move towards open science is progressing, there has been a strengthening internationally of data protection regulations that seek to safeguard the rights of data subjects while promoting the movement of data for the benefit of research. In line with this global shift, many jurisdictions in Africa are introducing data protection regulations, but there has been limited consideration of the regulation of data sharing for genomic research and biobanking in Africa. South Africa (SA) is one country that has sought to regulate the international sharing of data and has enacted the Protection of Personal Information Act (POPIA) 2013 that will change the governance and regulation of data in SA, including health research data, once it is in force. To identify and discuss challenges and opportunities in the governance of data sharing for genomic and health research data in SA, a two-day meeting was convened in February 2019 in Cape Town, SA with over 30 participants with expertise in law, ethics, genomics and biobanking science, drawn from academia, industry, and government. This report sets out some of the key challenges identified during the workshop and the opportunities and limitations of the current regulatory framework in SA., Competing Interests: No competing interests were disclosed.