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. Through a scoping review of twenty-four publicly available, English language DTAs relevant to health research, this article undertakes a comprehensive analysis, examining common clauses, their vital components, and charting a course for responsible data sharing through the provision of insights and practical guidance for drafting DTAs. The article underscores the need for attention to detail and an understanding of data protection legislation in order to ensure that DTAs align with the law and maximize legal certainty.

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. This reveals substantial implications for ethics committees, researchers, and participants, emphasising the need for a legal and ethical recalibration. Furthermore, the manuscript critiques South Africa's main ethics instruments for their inadequate guidance on benefit-sharing and proposes recommendations for enhancing the Department of Health's ethics guidelines. By advocating for a coherent, legally informed approach to ethical decision-making, the study underscores the need for integrating the proposed framework and legal insights into ethics guidelines. This comprehensive strategy aims not only to advance ethical practices within South Africa but also to contribute significantly to the global discourse on benefit-sharing in health research.

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. Consequently, the cross-border sharing of health data that includes genetic data requires careful navigation of the pertinent data protection legislation, in particular concerning the sharing of such data for research purposes. To help researchers navigate these legal frameworks, 12 African countries were analysed to develop country guides on cross-border data sharing. Results: Of the 12 countries that were analysed, ten have data protection laws in place (Botswana, Ghana, Kenya, Malawi, Nigeria, Rwanda, South Africa, Tanzania, Uganda, and Zimbabwe), while two countries (Cameroon and The Gambia) do not. With the exception of Ghana, all countries with data protection statutes or bills had additional requirements to be met when sharing personal data across borders. Consent and adequacy are the most common grounds for justifying the sharing of personal data across borders. Conclusion: Given the limitations of the current models of consent, consent is not a suitable basis to transfer large quantities of data for research. Adequacy is a common ground, but there are national differences in the implementation of this ground. Researchers must therefore analyse each national legal framework and make decisions on a case-by-case and country-by-country basis.

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. Furthermore, data is dealt with in a superficial, throw-away fashion in the draft MTA. The position with human biological material is not substantially better, as the draft MTA fails to recognise that human biological material can contain pathogens, which has important legal and ethical ramifications that are not sufficiently addressed. A central problem with the draft MTA is its use of the term 'steward', and avoidance of the legal concept of 'ownership'. This is not only misaligned with the South African legal framework, but also fails to consider the ethical case for recognising ownership. Finally, a call to embrace decolonial thinking in health research underscores the importance of recognising ownership in order to foster the growth of the local bio-economy. Key recommendations to reshape the draft MTA include: Making use of the eventual revised MTA optional, and allowing it to evolve with input from scientific and legal communities; regulating the transfer of associated data in a separate data transfer agreement that can be incorporated by reference in the MTA; enhancing guidance on liability and risk management in respect of human biological material that contains pathogens; and, finally, adopting a decolonial approach in health research governance, which requires recognising the ownership rights of South African research institutions.

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

[This corrects the article DOI: 10.3389/fphar.2023.1297353.].

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. Combined with the fact that it has an interest in having comprehensive rights in such data, it appears that the prudent policy for research institutions is to claim ownership of the human genomic data instances that they generate. This policy is tested against two opposing policy positions. The first opposing policy position is that research participants should own the data that relate to them. However, in light of data protection legislation that already provides extensive protections to research participants, bestowing data ownership on research participants would offer little benefit to such individuals, while leading to significant practical problems for research institutions. The second opposing policy position is that the concept of ownership should be abandoned in favour of data custodianship. This opposing position is problematic, as avoiding reference to ownership is a denial of legal reality and hence not a useful policy. Also, avoiding reference to ownership will leave research institutions with limited legal remedies in the event of appropriation of data by third parties. Accordingly, it is concluded that the wisest policy for research institutions is indeed to explicitly claim ownership of the human genomic data instances that they generate.

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 specific context 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. However, when only the pseudonymised dataset-without the linking dataset-is transferred to another entity, it is non-personal information in the hands of such a recipient, thus freeing the recipient from POPIA compliance. Such a delineation offers research institutions greater flexibility in sharing and using pseudonymised datasets. Importantly, because the original provider of the pseudonymised dataset (who has the means to re-identify the dataset) remains governed by POPIA, the privacy rights of data subjects are not undermined.

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 AB v. Minister of Social Development, 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. Following this, Ex Parte KF2 clarified the concept of the "prospective child" as relating to an idea, rather than an embryo. Finally, in Surrogacy Advisory Group v. Minister of Health, the controversial issue of preimplantation sex selection for non-medical reasons was examined. The court confirmed that the use of ARTs falls within the ambit of procreative freedom. While holding that preimplantation sex selection for non-medical reasons is inherently sexist, the court found that a woman's right to procreative freedom-including the sex identification of an in vitro embryo-outweighs other considerations. These landmark cases establish a robust groundwork for a progressive reproductive law in South Africa.

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. Further, it reviews the archival records of UNESCO's International Bioethics Committee to discover the rationale for qualifying the human genome as common heritage of humankind. The article finds that the common heritage of mankind framework remains relevant to the application of the human genome at the collective level. However, the framework is at odds with the individual dimension of the human genome based on individual personality rights. The article thus argues that the right to benefit from scientific progress and its applications offers an alternative international regulatory framework for human genomic research.

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. However, the development of AI-enhanced technologies in healthcare is fraught with legal, ethical, and human rights concerns. Currently, the use of AI in South African healthcare is not governed by sui generis legislation or ethical guidance focused exclusively and specifically on AI, although various provisions and principles from law and ethics find application. This article outlines these normative principles and explains their relationship with the extant legal obligations and regulatory framework as applied to the use of AI in radiology services in South Africa. The article concludes with three key recommendations for radiology practitioners using AI in South Africa. These are the need for: vigilant monitoring of AI use in practice, reforms to the liability framework, and appropriate guidance from local regulators and the Health Professions Council of South Africa on the ethical use of AI.

Open science and human genetic data: recommendations on South Africa's Draft National Open Science Policy.

The Draft National Open Science Policy, 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 Draft National Policy on Data and Cloud-another data-related policy initiative by the South African government. However, there is room for improvement in the Draft National Open Science Policy. In particular, it should: (a) rely on the right to freedom of scientific research to strengthen the policy; (b) rectify the omission of ownership from its policy analysis; and (c) retain a clear differentiation between human and non-human genetic data. This will ensure that the final policy is clearly anchored in the South African Constitution, and that the principle of "as open as possible, as closed as necessary" can be applied to human genetic data in a legally well informed and accountable way.

Mapping the regulatory landscape of AI in healthcare in Africa.

Introduction: 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. This paper offers a scoping exercise that maps the regulatory landscape of AI in healthcare (including health research) in certain African countries. Methods: This research is conducted across 12 African countries: Botswana, Cameroon, The Gambia, Ghana, Kenya, Malawi, Nigeria, Rwanda, South Africa, Tanzania, Uganda, and Zimbabwe. As limited specific AI legislation is found in these African countries, and because AI is informed by ancillary regulatory frameworks, we include data protection, digital health, consumer protection, and intellectual property in our research. A scoping review method was applied with a manual search of digital libraries with search terms customised for each repository consisting of core search terms for the various topics, including, among others, "law," "regulation," "artificial intelligence," "data protection," "intellectual property," and "digital health". Results and discussion: Analysis of the data demonstrated that while in the African countries under investigation there is no sui generis AI regulation, recent developments were found in areas that inform AI adoption, including in digital health, data protection, consumer protection, and intellectual property. Our findings highlight the fragmentation of the African AI regulatory landscape and illustrate the importance of continued AI regulatory development to ensure that Africa is well positioned for future AI adoption in health.

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. In sum, fertility clinics cannot deem embryos as abandoned and discard them if fertility patients fail to respond to a notice that the embryo storage agreement is about to expire. However, if there is non-payment for embryo storage by fertility patients and the fertility clinic has informed the fertility patients of other options available to them with respect to their embryos, and there is still no response, the fertility clinic is legally entitled - and legally obliged - to discard the embryos.

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. Accordingly, benefit sharing would be unlawful. The ramifications of this conclusion are far-reaching. Most pertinently, should any benefit-sharing agreements with research be put into practice, such agreements would be unenforceable and would expose all parties involved-including foreign collaborators-to criminal prosecution. The solution for proponents of benefit sharing in South Africa would be to lobby the South African government to revise the relevant law. However, as long as the law remains as it currently is, institutions and individuals all over the world who are involved in genomics research in South Africa would be well advised to comply with the law by not engaging in benefit sharing with research participants.

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. By analysing Mexico's regulatory approach based on genomic sovereignty and a divergent regulatory approach, viz Finland's human genomic research framework, we show that a human rights approach is more promising as it aligns with the state obligations under the right of everyone to participate in and benefit from scientific progress and its applications in international human rights law. We conclude by recommending that African states should anchor regulation of human genomic research on a human rights framework based on the right to science.

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. However, this raises various ethics concerns, including privacy expectations and informed consent. The concept of open consent offers a potential solution to these concerns by (a) being explicit about the research participant's data being in the public domain and the associated privacy risks, and (b) setting a higher-than-usual benchmark for informed consent by making use of the objective assessment of prospective research participants' understanding. Furthermore, in the South African context-where local culture is infused with Ubuntu and its relational view of personhood-community engagement is vital for establishing and maintaining an open access genomics database of South Africans. The South African National Health Research Ethics Council is called upon to provide guidelines for genomics researchers-based on open consent and community engagement-on how to plan and implement open access genomics projects.

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. The Committee ostensibly prioritises restricting HGE technology in the interest of society as a collective but, in doing so, neglects to consider the interests and rights of individuals. In this article, we suggest that this approach is imbalanced insofar as it fails to give sufficient weight to the promise of this technology in considering the regulation of risks and disregards the importance of the fundamental liberties underlying the use of HGE in its discussion of values and principles that should guide governance. How this is problematic is illustrated with reference to the Committee's openness to using patents as HGE governance tools and its blanket rejection of 'eugenics'. It is concluded that while the Committee makes some sensible recommendations on global governance, the Committee's approach of emphasising restrictions on HGE without also giving weight to the value of an open and liberal policy space is not something that liberal democratic states ought to follow.

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 lacuna in this proposal is highlighted with reference to the requirements of South Africa's Protection of Personal Information Act 4 of 2013 [POPIA]: Even if the NHA is amended as proposed, the goal of aligning South African law with prevailing ethics norms in South Africa would not necessarily be attained, as parental consent may still be required by POPIA. This article investigates whether this goal (of aligning the law with ethics) can be attained in a way that is compliant with POPIA. It is concluded that this is indeed possible in a number of ways, and that the best way to attain this goal is by requesting the South African Information Regulator to issue a guidance note to the effect that all health research projects that are approved by institutional health research ethics committees are to be regarded as being in the public interest, which would qualify such health research projects to be exempted from POPIA's consent requirements.

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. In the first scenario, informed consent is obtained to use a tissue sample for research and to commercialize the products of such research; in the second scenario, informed consent is materially deficient because of an honest mistake on the part of the research institution; and in the third scenario, informed consent is materially deficient due to willful disregard of the law on the part of the research institution. In the first two scenarios, ownership of the cell line created from the tissue sample would vest in the research institution, and the research participant would not have any legal action for financial compensation. However, in the third scenario, ownership of the cell line would vest in the research participant, who would be able to claim all profits made from trading the cell line. Whether the research institution acted in good faith is therefore a crucial determinant of the legal outcome.