SIGNIFICANCE: We elucidate the misinterpretations raised by Thaldar et al. (S Afr J Sci. 2023;119(11/12), Art. #15722) on our previous publication in which we outlined the data sharing governance landscape in selected African countries.

The movements of humans have a significant impact on population health. While studies of such movements are as old as public health itself, the COVID-19 pandemic has raised the profile of mobility research using digital technologies to track transmission routes and calculate the effects of health policies, such as lockdowns. In sub-Saharan Africa, the high prevalence of cell phone and smartphone use is a source of potentially valuable mobility data for public health purposes. Researchers can access call data records, passively collected in real time from millions of clients by cell phone companies, and associate these records with other data sets to generate insights, make predictions or draw possible policy implications. The use of mobility data from this source could have a range of significant benefits for society, from better control of infectious diseases, improved city planning, more efficient transportation systems and the optimisation of health resources. We discuss key ethical issues raised by public health studies using mobility data from cell phones in sub-Saharan Africa and identify six key ethical challenge areas: autonomy, including consent and individual or group privacy; bias and representativeness; community awareness, engagement and trust; function creep and accountability; stakeholder relationships and power dynamics; and the translation of mobility analyses into health policy. We emphasise the ethical importance of narrowing knowledge gaps between researchers, policymakers and the general public. Given that individuals do not really provide valid consent for the research use of phone data tracking their movements, community understanding and input will be crucial to the maintenance of public trust. SIGNIFICANCE: • Mobility data derived from cell phones are being increasingly used for health research and public health purposes in sub-Saharan Africa, with minimal individual consent and largely without public awareness. • While such data can have significant potential public health benefits, risks and concerns related to their collection and use in sub-Saharan African contexts have not been widely discussed. • Innovative community engagement initiatives, which are appropriate and responsive to sub-Saharan African contexts, need to be developed to address ethical challenge areas and help warrant public trust in mobility research.

Interest in the governance of big data is growing exponentially. However, finding the right balance between making large volumes of data accessible, and safeguarding privacy, preventing data misuse, determining authorship and protecting intellectual property remain challenging. In sub-Saharan Africa (SSA), research ethics committees (RECs) play an important role in reviewing data-intense research protocols. However, this regulatory role must be embedded in a context of robust governance. There is currently a paucity of published literature on how big data are regulated in SSA and if the capacity to review protocols is sufficient. The aim of this study was to provide a broad overview of REC members' awareness and perceptions of big data governance in SSA. A descriptive cross-sectional survey was conducted from April to July 2022. We invited 300 REC members to participate in our online survey via Research Electronic Data Capture (REDCap). A total of 140 REC members, representing 34 SSA countries, completed the online survey. Awareness of data governance laws, policies and guidelines was variable across the subcontinent. A quarter of respondents (25%) indicated that national regulations on the trans-border flow of research data are inadequate. Institutional policies on research data protection were also regarded as being inadequate. Most respondents (64%) believed that they lacked experience in reviewing data-intense protocols. Data governance and regulation in SSA need to be strengthened at both national and institutional levels. There is a strong need for capacity development in the review of data-intense research protocols on the subcontinent. SIGNIFICANCE: This is the first empirical survey in SSA in which awareness and perspectives of REC members have been explored specifically relating to the review of data-intense research protocols. Big data have raised new ethics and legal challenges, and this survey provides a broad overview of these challenges in SSA. Our study confirms that knowledge and awareness of legislative frameworks and ethics guidance in SSA vary considerably where big data are concerned. The research results could be useful for a range of stakeholders, including RECs, data scientists, researchers, research and academic institutions, government decision-makers and artificial intelligence (AI) coders.

The data ecosystem is complex and involves multiple stakeholders. Researchers and scientists engaging in data-intensive research collect, analyse, store, manage and share large volumes of data. Consequently, capturing researchers' and scientists' views from multidisciplinary fields on data use, sharing and governance adds an important African perspective to emerging debates. We conducted a descriptive cross-sectional survey and received 160 responses from researchers and scientists representing 43 sub-Saharan African countries. Whilst most respondents were satisfied with institutional data storage processes, 40% indicated that their organisations or institutions did not have a formally established process for storing data beyond the life cycle of the project. Willingness to share data was generally high, but increased when data privacy was ensured. Robust governance frameworks increased the willingness to share, as did the regulation of access to data on shared platforms. Incentivising data sharing remains controversial. Respondents were satisfied with exchanging their data for co-authorship on publications (89.4%) and collaboration on projects (77.6%). However, respondents were split almost equally in terms of sharing their data for commercial gain. Regarding the process of managing data, 40.6% indicated that their organisations do not provide training on best practices for data management. This could be related to a lack of resources, chronic institutional under-investment, and suboptimal research training and mentorship in sub-Saharan Africa. The sustainability of data sharing may require ethical incentive structures to further encourage researchers and scientists. Tangible infrastructure to facilitate such sharing is a prerequisite. Capacity development in data governance for researchers and scientists is sorely needed. SIGNIFICANCE: Data sharing is necessary to advance science, yet there are many constraints. In this study, we explored factors that promote a willingness to share, as well as constraining factors. Seeking potential solutions to improve data sharing is a scientific and ethical imperative. The standardisation of basic data sharing and data transfer agreements, and the development of a Data Access Committee will strengthen data governance and facilitate responsible data sharing in sub-Saharan Africa. Funders, institutions, researchers and scientists ought to jointly contribute to fair and equitable data use and sharing during and beyond the life cycle of research projects.

While the COVID-19 pandemic has captured the attention of the global community since the end of 2019, deadly health pandemics are not new to Africa. Tuberculosis (TB), malaria and human immunodeficiency virus (HIV) count amongst other serious diseases that have had a catastrophic impact on the African continent. Effective responses to such pandemics require high-quality, comprehensive data sets that can inform policymaking and enhance healthcare decision-making. While data is driving the information economy in the 21st century, the scarcity in Africa of carefully curated, large epidemiologic data sources and analytical capacity to rapidly identify and understand emerging infectious diseases poses a major challenge to mounting a time-sensitive response to unfolding pandemics. Data access, sharing and transfer between countries are crucial to effectively managing current and future health pandemics. Data access and sharing, however, raises questions about personal privacy, the adequacy of governance mechanisms to regulate cross-border data flows, and ethical issues relating to the collection and use of personal data in the interests of public health. Sub-Saharan Africa's most research-intensive countries are characterised by diverse data management and privacy governance frameworks. Such regional variance can impede time-sensitive data sharing and highlights the need for urgent governance reforms to facilitate effective decision-making in response to rapidly evolving public health threats. SIGNIFICANCE: We explore governance considerations that ought to apply to the collection, transfer, and use of data in public health emergencies. Specifically, we provide an overview of the prevailing data sharing governance landscape in selected African countries. In doing so, we identify limitations and gaps that impede effective data collation, sharing and analysis. This work could find utility amongst a range of stakeholders, including bioinformaticians, epidemiologists, artificial intelligence coders, and government decision-makers. While this work focuses primarily on an African context, the issues explored are of universal concern and therefore of relevance to a broader international audience.

The COVID-19 pandemic has warranted modifications to clinical research implementation to ensure adherence to public health and safety measures. Often, this modification has necessitated a deviation from the traditional face-to-face approach to an electronic or hybrid consent process. We assessed the acceptability and preference for electronic consent and explored understanding of the electronic consent information - an outcome which is vital in providing reassurance that consent is provided with full appreciation of the risks and benefits of study participation. In this descriptive study, healthcare professionals (HCPs) were invited, through a database of HCP contacts, snowball sampling and advertisement, to participate in an online survey between 14 July 2021 and 17 September 2021, to explore their experiences of providing electronic consent for enrolment into the largest implementation trial of a COVID vaccine in South Africa (SISONKE Trial). Descriptive analysis was used to characterise respondents and categorical data were expressed as frequencies. The prevalence of recurring responses to open-ended questions allowed for the identification of themes. A total of 1025 HCPs completed the online survey. Access to a COVID-19 vaccine was the strongest motivating factor for enrolment (82.3%) into the SISONKE Trial. Over a third of participants (38.6%) were not able to discuss the study with research staff. While the majority of participants (85.2%) indicated that online consent was acceptable, it was recognised that acceptability was context specific. Although 64% indicated awareness that reporting both a positive COVID test and adverse events were requirements, a significant percentage (32%) did not recall that the reporting period was 2 years. The electronic consent process was easily navigated by educated HCPs with access to electronic devices and data. Vaccine access was the most important motivation for participation, thus raising questions about how voluntary the consent process was and the role of desperation in deciding to participate. SIGNIFICANCE: • Navigation of the electronic consent process for participation in a COVID-19 vaccine implementation trial is not a challenge for educated healthcare professionals with access to electronic devices and data. However, technical skills and access to technology may impact the integrity of the informed consent process for lay research participants. • Motivation to join research studies for access to scarce resources impacts negatively on the authenticity of the consent processes, as participation may be informed but not truly voluntary, and is an issue that ethics committees and researchers should address.

The legitimacy of mandatory vaccine policies is underscored by a public health ethics framework based on the principles of limited autonomy, social justice and the common good. Ideally, vaccine uptake ought to occur on a voluntary basis as an act of solidarity to ensure that everyone is protected. Given that the altruistic approach has failed and vaccine uptake remains sub-optimal in South Africa, in this paper, I argue for vaccine mandates, in a post-Omicron context. This viewpoint is substantiated by several considerations. Healthcare workers are fatigued after 2 years of treating COVID-19 and many are still treating patients with post-viral syndromes, mental health conditions and cardiovascular complications. Health systems remain under pressure as people with non-COVID diseases, neglected during the pandemic, are also now presenting to medical practices and hospitals. Although South Africa has emerged from a relatively less severe fourth wave of COVID-19, there have been many deaths. Vaccine and natural immunity in a relatively young general population has been advantageous. However, the country has a high prevalence of HIV and those who are untreated may not be able to clear the coronavirus easily. Similarly chronic illnesses place many at risk for severe disease from COVID variants, especially if unvaccinated. The future is shrouded in uncertainty. The next variant could be similar to or less severe than Omicron, yet still impact negatively on health systems, education and the economy. Physical distancing is not ideal in many low socio-economic settings, making vaccines an important component of our prevention toolbox. Our safest option now is to ensure that as many South Africans as possible are vaccinated and receive boosters. Vaccine mandates work to achieve this end. SIGNIFICANCE: The legitimacy of COVID-19 vaccine mandates post-Omicron is explored from an ethical perspective, given that the fifth wave remains unpredictable in South Africa - a country with a high prevalence of HIV, vulnerable unvaccinated adults and children, and fragile public health systems. The emergence of new variants is uncertain. However, vaccines are central to an appropriate response to protect public health, health systems and the economy.

Humanitarian emergencies result in a breakdown of critical health-care services and often make vulnerable communities dependent on external agencies for care. In resource-constrained settings, this may occur against a backdrop of extreme poverty, malnutrition, insecurity, low literacy and poor infrastructure. Under these circumstances, providing food, water and shelter and limiting communicable disease outbreaks become primary concerns. Where effective and safe vaccines are available to mitigate the risk of disease outbreaks, their potential deployment is a key consideration in meeting emergency health needs. Ethical considerations are crucial when deciding on vaccine deployment. Allocation of vaccines in short supply, target groups, delivery strategies, surveillance and research during acute humanitarian emergencies all involve ethical considerations that often arise from the tension between individual and common good. The authors lay out the ethical issues that policy-makers need to bear in mind when considering the deployment of mass vaccination during humanitarian emergencies, including beneficence (duty of care and the rule of rescue), non-maleficence, autonomy and consent, and distributive and procedural justice.

Las emergencias humanitarias causan el desplome de los servicios de atención de salud esenciales y, a menudo, provocan que la atención sanitaria de las comunidades vulnerables pase a depender de organismos externos. En entornos con recursos limitados esto puede darse en un contexto de pobreza extrema, desnutrición, inseguridad, bajos niveles de alfabetización e infraestructuras deficientes. Bajo estas circunstancias, suministrar alimentos, agua y refugio, así como limitar la aparición de brotes de enfermedades transmisibles representan las principales preocupaciones. Cuando se dispone de vacunas eficaces y seguras para reducir el riesgo de aparición de brotes de enfermedades, la distribución potencial de las mismas constituye un factor clave en las situaciones de emergencia sanitaria. Las consideraciones éticas son fundamentales a la hora de decidir sobre la distribución de las vacunas. La asignación de vacunas con suministro limitado, los grupos destinatarios de las mismas, las estrategias de entrega, así como la monitorización y los estudios durante las emergencias humanitarias graves implican consideraciones éticas que, a menudo, derivan de un enfrentamiento entre el beneficio individual y el bien común. Los autores exponen los problemas éticos que los responsables políticos deben tener en cuenta a la hora de considerar cómo distribuir la vacunación masiva durante las emergencias humanitarias, lo cual incluye principios como la beneficencia (el deber de atención y la regla del rescate), la no maleficencia, la autonomía y el consentimiento, así como la justicia distributiva y procesal.

Les urgences humanitaires entraînent une rupture des services de soins de santé essentiels et elles rendent souvent les communautés vulnérables dépendantes des organismes externes pour leurs soins. Dans les milieux où les ressources sont comptées, cela peut se produire sur fond d'extrême pauvreté, de malnutrition, d'insécurité, de faible niveau d'alphabétisation et d'infrastructures insuffisantes. Dans ces circonstances, fournir nourriture, eau et abri, tout en limitant les épidémies de maladies transmissibles, devient une préoccupation centrale. Lorsqu'il existe des vaccins sûrs et efficaces pour limiter les risques d'épidémies, leur éventuel déploiement est un facteur clé pour satisfaire les besoins sanitaires d'urgence. Les considérations éthiques sont essentielles pour se prononcer sur le déploiement de la vaccination. La distribution de vaccins en quantités limitées, les groupes cibles, les stratégies de vaccination, la surveillance et la recherche lors de situations d'urgence humanitaire graves impliquent tous des considérations éthiques souvent nées de la tension entre le bien individuel et le bien commun. Les auteurs exposent les questions éthiques que les décideurs doivent garder à l'esprit lorsqu'ils envisagent le déploiement d'une vaccination de masse pendant les urgences humanitaires, notamment la bénéficience (devoir de diligence et devoir d'assistance), la non-maléficience, l'autonomie et le consentement, ainsi que la justice de répartition et l'équité procédurale.