The anatomy of a data transfer agreement for health research.

In a data-driven era, the exchange and safeguarding of personal information has become paramount. Data transfer agreements (DTAs) serve to guard privacy, defining the rules for sharing and protecting sensitive data. Yet, the complexities surrounding issues such as data privacy, intellectual property, and dispute resolution within these agreements pose challenges that demand careful consideration.

Benefit-sharing with human participants in health research in South Africa: A call for clarity.

This study critically examines the concept of benefit-sharing in the context of health research involving human participants in South Africa, identifying a significant gap in the precision and application of terminology. It introduces a new terminological framework designed to provide clarity and facilitate standardisation in both national and international discourse on benefit-sharing. The analysis extends to the complex legal landscape in South Africa, highlighting the nuances of mandated, permitted, and prohibited practices of benefit-sharing across various statutes.

Cross-border data sharing for research in Africa: An analysis of the data protection and research ethics requirements in 12 jurisdictions.

Background: In recent years, there has been a notable uptake in genomic and health-related research activities across the African continent. Similarly, there has been increased introduction of data protection legislation that affects the sharing of personal data such as health data and genomic data, including for research. Many of these statutes have stricter requirements when sharing personal data across borders.

Corrigendum: Liability for harm caused by AI in healthcare: an overview of the core legal concepts.

[This corrects the article DOI: 10.3389/fphar.2023.

Forcing a square into a circle: why South Africa's draft revised material transfer agreement is not fit for purpose.

The South African National Health Research Ethics Council (NHREC) recently released a final draft revision of the standard material transfer agreement (MTA) that was promulgated into law in 2018. This new draft MTA raises pertinent questions about the NHREC's mandate, the way in which the draft MTA deals with data and with human biological material, and its avoidance of the concept of ownership. After South Africa's data protection legislation, the Protection of Personal Information Act (POPIA), became operational in mid 2021, the legal landscape changed and it is doubtful that the NHREC has a residual mandate to govern personal information in health research.

The wisdom of claiming ownership of human genomic data: A cautionary tale for research institutions.

This article considers the practical question of how research institutions should best structure their legal relationship with the human genomic data that they generate. The analysis, based on South African law, is framed by the legal position that although a research institution that generates human genomic data is not automatically the owner thereof, it is well positioned to claim ownership of newly generated data instances. Given that the research institution exerts effort to generate the data, it can be argued that it has a moral right to claim ownership of such data.

Liability for harm caused by AI in healthcare: an overview of the core legal concepts.

The integration of artificial intelligence (AI) into healthcare in Africa presents transformative opportunities but also raises profound legal challenges, especially concerning liability. As AI becomes more autonomous, determining who or what is responsible when things go wrong becomes ambiguous. This article aims to review the legal concepts relevant to the issue of liability for harm caused by AI in healthcare.

Building a Progressive Reproductive Law in South Africa.

This article delves into the expansion of procreative freedom in relation to assisted reproductive technologies (ARTs) in South African law, with reference to three seminal cases. In the case of , the minority of the South African Constitutional Court held that the constitutional right to procreative freedom is applicable to ARTs. Importantly, both the minority and the majority agreed on the principle of procreative non-maleficence-the principle that harm to the prospective child constitutes a legitimate reason to limit the procreative freedom of the prospective parents.

Does data protection law in South Africa apply to pseudonymised data?

The use of pseudonymised datasets is increasingly commonplace as research institutions seek to balance data utility with data security. Yet, a crucial question arises: How does South Africa's Protection of Personal Information Act (POPIA) govern these datasets, especially given their ambiguous state between de-identification and possible re-identification? A thorough examination of POPIA suggests that the determination of whether a pseudonymised dataset is personal information-and thus whether processing the dataset falls within POPIA's purview-must be informed by the of the responsible party in possession of the pseudonymised dataset. When a research institution retains both the pseudonymised dataset and its linking dataset, the pseudonymised dataset remains identifiable and is thus personal information that falls within POPIA's purview.

The human genome as the common heritage of humanity.

While debate on the international regulation of human genomic research remains unsettled, the Universal Declaration on the Human Genome and Human Rights, 1997 qualifies the human genome as "heritage of humankind" in a symbolic sense. Using document analysis this article assesses whether, how and to what extent the common heritage framework is relevant in regulation of human genomic research. The article traces the history of the Human Genome Project to reveal the international community's race against privatization of the human genome and its resulting qualification as the common heritage of humanity.

Legal and ethical principles governing the use of artificial intelligence in radiology services in South Africa.

Artificial intelligence (AI) will drastically change the healthcare system. Radiology is one speciality that is most affected as AI algorithms are increasingly used in diagnostic imaging. AI-enhanced health technologies will, inter alia, increase workflow efficiency, improve diagnostic accuracy, reduce healthcare-related costs, and help alleviate medical personnel shortages in under-resourced settings.

Open science and human genetic data: recommendations on South Africa's .

The , which was shared by the South African government with stakeholders in 2022, is an encouraging step forward as it aims to promote the practice of open science in South Africa through a system of incentives. Since South Africa is constitutionally committed to be an open and democratic society, this approach is preferable to the approach of state control that characterizes the -another data-related policy initiative by the South African government. However, there is room for improvement in the .

Mapping the regulatory landscape of AI in healthcare in Africa.

Artificial intelligence (AI)-enhanced technology has seen unprecedented expansion in the recent past. This growth brings with it huge opportunities for the positive transformation of the economy, business, healthcare, and society. However, a critical question is whether, and to what extent, regulatory measures and mechanisms have been implemented to safeguard its design, development, and deployment.

Frozen and forgotten: What are South African fertility clinics to do with surplus cryopreserved embryos once their patients lose interest?

As is the case around the globe, South African fertility clinics face an ever-expanding problem: what to do with the growing number of surplus cryopreserved embryos. Fertility clinics remain hesitant to destroy these abandoned embryos, partly because of concerns about the legal ramifications. This article clarifies the legal position in South Africa and offers practical recommendations to assist fertility clinics in managing abandoned embryos.

Regulating human genomic research in Africa: why a human rights approach is a more promising conceptual framework than genomic sovereignty.

This article revisits the debate on the regulation of human genomic research, with a focus on Africa. The article comprehensively examines the concept of genomic sovereignty, which was invoked mainly in the global South as a conceptual framework for state regulation of human genomic research. It demonstrates that genomic sovereignty has no utility value in human genomic research as it violates the rights of individuals and researchers.

Is benefit sharing with research participants lawful in South Africa? An unexplored question in the governance of genomics research.

Despite advocacy in favour of benefit sharing with research participants in genomics research that is conducted in South Africa, there has been little critical legal engagement with this concept. That is what this article provides by posing the hitherto unexplored-but foundational-question: Is benefit sharing with research participants lawful in South Africa? The answer is clearly 'no'. South African law provides that it is unlawful to provide any financial or other reward to research participants for donating biospecimens-except for reimbursement of reasonable costs incurred.

An imbalanced approach to governance? An analysis of the WHO's position on human genome editing.

In 2021, the WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing (the 'Committee') published its policy recommendations. It proposes, inter alia, a set of nine values and principles to inform the governance of human genome editing (HGE) and makes recommendations regarding how HGE can be regulated. While these proposals contain valuable contributions to the discourse on the global governance of HGE, they also contain elements that call for heightened attention to the risks of the technology, and a countervailing focus on the potential benefits of the technology is missing.

Toward an open access genomics database of South Africans: ethical considerations.

Genomics research holds the potential to improve healthcare. Yet, a very low percentage of the genomic data used in genomics research internationally relates to persons of African origin. Establishing a large-scale, open access genomics database of South Africans may contribute to solving this problem.

Who would own the HeLa cell line if the Henrietta Lacks case happened in present-day South Africa?

The HeLa cell line was created in 1951 without consent from Henrietta Lacks, the person whose tissue sample was used. In 2021, the descendants of Henrietta Lacks sued a well-known biotechnology company for the profits it made from the HeLa cell line. In this article, ownership of the cell lines is investigated from a South African legal perspective by considering three possible contemporary scenarios bearing points of similarity to the Henrietta Lacks case.

Promoting Equality in the Governance of Heritable Human Genome Editing through Ubuntu: Reflecting on a South African Public Engagement Study.

In a recent public engagement study on heritable human genome editing (HHGE) conducted among South Africans, participants approved of using HHGE for serious health conditions-viewing it as a means of bringing about valuable social goods-and proposed that the government should actively invest resources to ensure everyone has equal access to the technology for these purposes. This position was animated by the view that  have a claim to these social goods, and this entitlement justified making HHGE available in the present. This claim can be ethically justified in the Ubuntu ethic (deriving from South Africa) as it (a) emphasizes the interests of the community, and (b) espouses a metaphysical conception of the community that transcends the present generation and includes past and future generations.

Children as participants in health research in South Africa: A response to Labuschaigne, Mahomed and Dhai.

A complex network of ethico-legal rules makes it difficult for health researchers in South Africa to lawfully recruit adolescents to the kinds of sensitive studies where it may be ethically appropriate to proceed without notifying parents or obtaining parental consent. This article responds to a recent proposal to amend the blanket requirement for mandatory parental consent presently contained in section 71 the South African National Health Act 61 of 2003 [NHA]. The proposed amendment is intended to bring the NHA into alignment with South Africa's 2015 Department of Health Guidelines on Ethics in Health Research by permitting greater flexibility for a health research ethics committee to waive parental consent, and permit adolescents to consent independently.

A deliberative public engagement study on heritable human genome editing among South Africans: Study results.

This paper reports the results of a public engagement study on heritable human genome editing (HHGE) carried out in South Africa, which was conducted in accordance with a study protocol that was published in this journal in 2021. This study is novel as it is the first public engagement study on HHGE in Africa. It used a deliberative public engagement (DPE) methodology, entailing inter alia that measures were put in place to ensure that potential participants became informed about HHGE, and that deliberations between the participants were facilitated with the aim of seeking consensus.

The multidimensional legal nature of personal genomic sequence data: A South African perspective.

This article provides a comprehensive analysis of the various dimensions in South African law applicable to personal genomic sequence data. This analysis includes property rights, personality rights, and intellectual property rights. Importantly, the under-investigated question of whether personal genomic sequence data are capable of being owned is investigated and answered affirmatively.