A multitude of legislation impacts the use of samples and data for research in South Africa. With the coming into effect of the Protection of Personal Information Act No. 4 of 2013 in July 2021, recent attention has been given to safeguarding research participants’ personal information. The protection of participants’ privacy in research is essential, but it is not the only risk at stake in the use and sharing of personal information. Other rights and interests that must also be considered (...) and safeguarded include the right to non-discrimination, the right to dignity, and the right to enjoy the benefits of scientific progress. This can be achieved by ensuring that the ethical values and universal principles that underpin the research landscape, namely equity, reciprocity, justice and solidarity, are embedded in the regulatory framework for the management and use of personal information. This paper advocates an integrated bioethics approach to the use of personal information for research in SA. A key feature in embedding such an approach is a Data Transfer Agreement that appropriately integrates the safeguards and protections set out by our regulatory framework with bioethical rules and procedures when personal information is used and shared for research purposes. This paper thus calls for the development of a national DTA that is guided by key ethical principles when data are shared for research purposes. This paper will be followed by a webinar on 23 June 2022 hosted by the Department of Science and Innovation and the SA Medical Research Council, where the recommendations and suggestions set out herein will be unpacked, discussed and debated by relevant stakeholders. (shrink)

Although the concept of biobanking is not new, the open and evolving nature of biobanks has created profound ethical, legal, and social implications, including issues around informed consent, community engagement, secondary uses of materials over time, ownership of materials, data sharing, and privacy. Complexities also emerge because of increasing international collaborations and differing national positions. In addition, the degrees and topics of concern vary as legislative, ethical, and social frameworks differ across developed and developing countries. Implementing national laws in an (...) internationally consistent manner is also problematic. However, these concerns should not cause countries, especially developing countries, to lag behind as this novel wave of research gains momentum, particularly while several biobank initiatives are already underway in the developing world. As the law has always struggled to keep up with the fast-evolving scientific arena, this article seeks to identify the ethico-legal frameworks in place in the United Kingdom, Australia, Uganda, and South Africa, for human biobank research, in an attempt to compare and contextualize the approaches to human biobanking in specific developed and developing countries. (shrink)

With biobank research on the increase and the history of exploitation in Africa, it has become necessary to manage the transfer of human tissues across national boundaries. There are many accepted templates of Material Transfer Agreements that currently exist internationally. However, these templates do not address the specific concerns of South Africa and even of Africa as a continent. This article will examine three significantly important ethico-legal concepts that were deliberated and carefully adapted by a South African Institution to suit (...) the transfer of Human Biological Materials and associated data for biobank research, namely: informed consent; benefit sharing arrangements; and ownership together with intellectual property rights in human tissues. The discussion includes an analysis of current practice; the ethico-legal challenges in the South African/African context; the decisions made with regard to how the related ethico-legal challenges were addressed in the MTA; and justifications for implementing these decisions. The processes considered could be of benefit to other developing world countries who consider it necessary to manage the transfer of HBMs across national boundaries. (shrink)

Broad consent is permitted by the South African National Department of Health Ethics Guidelines but appears to be prohibited by section 13(1) of the Protection of Personal Information Act 4 of 2013. Additionally, the Act mandates that all personal data (including biobank sample data) be collected for lawful, explicit, and clearly defined purposes. There is possibility for ambiguity in interpretation because of this discrepancy between the two instruments. Given the association between the transfer of samples and data, the long-term nature (...) of biobanking, which makes it impractical to provide too much or enough information because it is simply not available at the time of sample collection, and the various ways that the Protection of Personal Information Act 4 of 2013 have been interpreted, we aim to demonstrate that South Africa’s current regulatory framework should appropriately permit broad consent use for biobank research where the transfer of samples and their associated data are contemplated. In summary, the proposed amendments include removing regulatory ambiguity regarding broad consent use, ensuring adequate safeguards for research participants by specifying rules for data access and personal information processing, and incorporating consent form information requirements into the national Consent Template. (shrink)

Biobanks are repositories that store human biological materials and their associated data. They are rapidly becoming part of national and international networks and give rise to unique ethico-regulatory issues. Whether consent is informed and whether this term should be used when specimens are collected for biobank research is questionable. Where risks occur, they are usually social and relate to identifiability. Public trust and confidence are important for the success of this type of research. Consensus is growing that governance of biobanks (...) should be harmonised. Controlled specimen and data access agreements are essential. The South African National Health Act and its Regulations, that provide the foundation for the legal framework with regard to human tissue and research in South Africa, are silent on the issue of biobanks and the law lags behind while science and technology advance rapidly. The use of biobank assets will lead to significant benefits in human health and should be encouraged while taking account of the associated ethical, legal and social issues and working towards a balance between these two positions. (shrink)

Mitochondrial donation or mitochondrial transfer enables a woman with mitochondrial disease to have a genetically related child without transmitting the disease to the child. The techniques used for mitochondrial donation or transfer which are maternal spindle transfer or pro-nuclei transfer, require three gametes to ultimately produce a healthy embryo. Both these techniques result in the child inheriting nuclear DNA from the intending parents and mitochondrial DNA from the female donor. Following the legalisation of mitochondrial donation in the UK, after a (...) rigorous process of scientific and ethical review, and the birth of another baby using the technique, coupled with the fact that there is no cure for mitochondrial disease, suggests that it is prudent for us to consider this reproductive intervention and its application in the South African setting. In addition, the 2019 UNESCO Report of the International Bioethics Committee (IBC) on assisted reproductive technologies (ART) and parenthood, encourages debate on changes in models of parenthood influenced by ART including the emergence of new models of families and forms of parenthood that extend beyond the classical rule of mater semper certa est (the mother is always known). ART, in particular mitochondrial donation, challenges this rule. The aim of this paper is to provide an outline of the legal and ethical positions of mitochondrial donation and resume the discussion with specific focus on the South African context. (shrink)

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. (shrink)

Biobanks are repositories that store human biological materials and their associated data. They are rapidly becoming part of national and international networks and give rise to unique ethico-regulatory issues. Whether consent is informed and whether this term should be used when specimens are collected for biobank research is questionable. Where risks occur, they are usually social and relate to identifiability. Public trust and confidence are important for the success of this type of research. Consensus is growing that governance of biobanks (...) should be harmonised. Controlled specimen and data access agreements are essential. The South African National Health Act and its Regulations, that provide the foundation for the legal framework with regard to human tissue and research in South Africa, are silent on the issue of biobanks and the law lags behind while science and technology advance rapidly. The use of biobank assets will lead to significant benefits in human health and should be encouraged while taking account of the associated ethical, legal and social issues and working towards a balance between these two positions. (shrink)

Private medical aids are essentially non-profit organisations that aim to deliver speedy treatment and should prevent members from unexpected, out of pocket expenses for medical care. However, although the latest statistics show that 16.2% of individuals in South Africa were 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 Case decision, this article seeks to explore whether there is justice in the provision of healthcare services, specifically within the private sector in South Africa. (shrink)

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. (shrink)

The people of Gaza endure physical traumas, and psychological and social wounds directly linked to the combination of military occupations and the closing of its border, essentially forcing and trapping them in despair. The destruction of healthcare infrastructure in particular, has methodically added strain on an already hopeless situation, severely affecting the availability and accessibility of essential healthcare services for the population, which further perpetuates the cycle of peoples suffering. Such suffering has escalated to extreme proportions in 2023. As the (...) violence and attacks continue with flagrant disregard of the Geneva and Hague conventions, the Rome Statute, occupational law, and international and humanitarian law, amid outcries from the international community, we see hospitals, that are traditionally regarded as sanctuaries of humanity transform into corridors of horror. (shrink)

The involuntary admission or treatment of a mentally ill individual is highly controversial, as it may be argued that such intervention infringes on individual autonomy and the right to choose a particular treatment. However, this argument must be balanced with the need to provide immediate healthcare services to a vulnerable person who cannot or will not make a choice in his or her own best interests at a particular time. A study carried out in Gauteng Province, South Africa, highlighted the (...) fact that the annual rate of involuntary admissions increased by almost double from 2007 to 2008. This could indicate that healthcare providers are not treating patients without their consent only when this is absolutely necessary. Alternatively, it could indicate that healthcare professionals are more aware of the provisions of the Mental Health Care Act and relevant national policy guidelines. Or it could suggest that more patients are presenting with mental illnesses or disorders that require their involuntary admission. It remains for strategies to be developed that change negative perceptions and inequities for individuals with mental illness. Above all, the strategies should be underpinned by inalienable respect for mentally ill individuals – a concept that was blatantly disregarded in the Life Esidimeni case. In this article, we highlight the functions of mental health review boards and their accountability where involuntary admissions are concerned, while emphasising the protections for mentally ill persons as a vulnerable population group, as set out in the SA Constitution. (shrink)