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.

A pathway to strengthening open science: comments on the draft South African Ethics in Health Research Guidelines.

The recently released draft South African Ethics in Health Research Guidelines: Principles, Processes and Structures (Draft Guidelines) by the National Health Research Ethics Council recognize open data and provide guiding principles for this in the context of health research in South Africa. While its inclusion is a positive development, there is room for improvement. Although the Draft Guidelines leverage the Draft National Policy on Data and Cloud, it lacks incorporation of other relevant government policies, notably the Draft National Open Science Policy, and fails to sufficiently detail the principles of open science and open access. This limited scope and lack of comprehensive definition and detailed guidance present challenges for researchers in conducting ethical and responsible health research in South Africa. It constrains the Draft Guidelines from fully aligning with national imperatives and from fostering African-centric approaches. To address these issues, it is recommended that the Draft Guidelines integrate broader policies and principles, enhance clarity through comprehensive definitions, provide detailed guidance on open access, and promote African-centric approaches. Implementing these solutions will strengthen the Draft Guidelines, aligning them with national visions of open science, and thereby harnessing the full potential of South Africa's diverse scientific community in advancing health research.

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.

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.

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. In addition to being susceptible of ownership, personal genomic sequence data are also the object of data subjects' personality rights, and can also be the object of intellectual property rights: whether on their own qua trade secret or as part of a patented invention or copyrighted dataset. It is shown that personality rights constrain ownership rights, while the exploitation of intellectual property rights is constrained by both personality rights and ownership rights. All of these rights applicable to personal genomic sequence data should be acknowledged and harmonized for such data to be used effectively.

Direct-to-Consumer Genetic Testing in South Africa: Stumbling Over the First Legal Hurdle?

Despite the growing popularity of direct-to-consumer genetic testing, there is minimal South African literature on the topic. The limited available research suggests that direct-to-consumer genetic testing is unregulated. However, we suggest that direct-to-consumer genetic testing is indeed regulated, and unusually so. The first step in the process - the collection of a saliva sample by consumers themselves - is unlawful on a plain reading of the National Health Act 61 of 2003 and the Regulations Relating to the Use of Human Biological Material. This is because these statutes require that certain healthcare professionals must remove saliva for genetic testing. Yet, on closer analysis, such an apparent ban on the self-collection of saliva is neither aligned with a purposive interpretation of the relevant legislation, nor would it survive constitutional scrutiny - as it impedes an individual's autonomy. It is concluded that, contrary to a plain reading of the relevant statutes, individuals can lawfully collect their own saliva for direct-to-consumer genetic testing. To provide legal clarity we recommend that the relevant provisions of the National Health Act 61 of 2003 and Regulations Relating to the Use of Human Biological the Material be amended to allow individuals to collect their own saliva samples.