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The article focuses on the Data Science for Health Discovery and Innovation in Africa (DS-I Africa) Initiative, which aims to leverage big data and AI for health research in sub-Saharan Africa. Topics include the potential benefits and challenges of data science; the importance of data management and integrity, ethical and legal issues related to data collection and use; and the role of mobile phone data in public health research.

Concerns have been raised around the alleged commercialisation of South African genetic material by various research institutes nationally and abroad. We consider whether the Protection of Personal Information Act in South Africa will conflict with or complement existing protections in health law and research ethics. The Act is not applicable to de‐identified samples that cannot be re‐identified but we question whether genetic samples can ever be truly de‐identified. The research participants in this matter provided consent for use of their samples for research but did not consent to commercialisation by global research institutions, and neither did the researchers. We suggest that consent models incorporating broad consent as an option should include explicit discussions around benefit sharing and commercialisation. Mistrust between researchers and participants impedes scientific research and can harm relationships built up over the years between South African researchers and local communities. [ABSTRACT FROM AUTHOR]

Background: Several factors thwart successful data sharing—ambiguous or fragmented regulatory landscapes, conflicting institutional/researcher interests and varying levels of data science-related expertise are among these. Traditional ethics oversight mechanisms and practices may not be well placed to guarantee adequate research oversight given the unique challenges presented by digital technologies and artificial intelligence (AI). Data-intensive research has raised new, contextual ethics and legal challenges that are particularly relevant in an African research setting. Yet, no empirical research has been conducted to explore these challenges. Materials and methods: We explored REC members' views and experiences on data sharing by conducting 20 semi-structured interviews online between June 2022 and February 2023. Using purposive sampling and snowballing, we recruited representatives across sub-Saharan Africa (SSA). We transcribed verbatim and thematically analysed the data with Atlas.ti V22. Results: Three dominant themes were identified: (i) experiences in reviewing data sharing protocols, (ii) perceptions of data transfer tools and (iii) ethical, legal and social challenges of data sharing. Several sub-themes emerged as: (i.a) frequency of and approaches used in reviewing data sharing protocols, (i.b) practical/technical challenges, (i.c) training, (ii.a) ideal structure of data transfer tools, (ii.b) key elements of data transfer tools, (ii.c) implementation level, (ii.d) key stakeholders in developing and reviewing a data transfer agreement (DTA), (iii.a) confidentiality and anonymity, (iii.b) consent, (iii.c) regulatory frameworks, and (iii.d) stigmatisation and discrimination. Conclusions: Our results indicated variability in REC members' perceptions, suboptimal awareness of the existence of data protection laws and a unanimously expressed need for REC member training. To promote efficient data sharing within and across SSA, guidelines that incorporate ethical, legal and social elements need to be developed in consultation with relevant stakeholders and field experts, along with the training accreditation of REC members in the review of data-intensive protocols. [ABSTRACT FROM AUTHOR]

The COVID‐19 pandemic has raised important universal public health challenges. Conceiving ethical responses to these challenges is a public health imperative but must take context into account. This is particularly important in sub‐Saharan Africa (SSA). In this paper, we examine how some of the ethical recommendations offered so far in high‐income countries might appear from a SSA perspective. We also reflect on some of the key ethical challenges raised by the COVID‐19 pandemic in low‐income countries suffering from chronic shortages in health care resources, and chronic high morbidity and mortality from non‐COVID‐19 causes. A parallel is drawn between the distribution of severity of COVID‐19 disease and the classic "Fortune at the bottom of the pyramid" model that is relevant in SSA. Focusing allocation of resources during COVID‐19 on the 'thick' part of the pyramid in Low‐to‐Middle Income Countries (LMICs) could be ethically justified on utilitarian and social justice grounds, since it prioritizes a large number of persons who have been economically and socially marginalized. During the pandemic, importing allocation frameworks focused on the apex of the pyramid from the global north may therefore not always be appropriate. In a post‐COVID‐19 world, we need to think strategically about how health care systems can be financed and structured to ensure broad access to adequate health care for all who need it. The root problems underlying health inequity, exposed by COVID‐19, must be addressed, not just to prepare for the next pandemic, but to care for people in resource poor settings in non‐pandemic times. [ABSTRACT FROM AUTHOR]

The Covid‐19 pandemic has sparked rapid and voluminous production of bioethics commentary in popular media and academic publications. Many of the discussions are new twists on an old theme: how to fairly allocate scarce medical resources, such as ventilators and intensive care unit beds. In this essay, we do not add another allocation scheme to the growing pile, partly out of appreciation that such schemes should be products of inclusive and transparent community engagement and partly out of recognition of their limited utility for physicians working in the field. Instead, we make the more modest claim that context matters when making such decisions and, more specifically, that recommendations from high‐income countries about fair allocation during Covid‐19 should not be cut and pasted into low‐income settings. We offer a few examples of why seemingly universal, well‐intentioned ethical recommendations could have adverse consequences if unreflectively applied in sub‐Saharan Africa. [ABSTRACT FROM AUTHOR]

Biobanking has become a global activity of growing relevance to research. The African continent is part of this global effort to collect, store and re-use samples and data. International research and capacity development efforts such as the Human Health and Heredity Africa (H3 Africa) project seek to empower African researchers and research participants alike. Given that African genetic diversity is a unique global resource, retaining samples and data on the continent is critical to building trust in communities who have been historically exploited in the name of research. Diverse and multiple stakeholders are involved in biobanking. Engaging authentically with these various stakeholder groups is a pre-requisite to building trust. Likewise, establishing legitimacy of biobanks also contributes to development of trust in communities. This paper reflects on the concepts of trust, legitimacy and stakeholder engagement. Empirical research conducted on researchers in South Africa as well as on research participants and Community Advisory Board (CAB) members is briefly presented. The development of educational pamphlets on genetics, genomics and biobanking and an educational video on biobanking in conjunction with CAB members is described. These tools were used to engage research participants and CAB members in discussions around biobanking. Establishing biobanks in African settings is challenging. However, efforts must be made to engage with relevant stakeholders on the basis of mutual respect and trust. [ABSTRACT FROM AUTHOR]

Innovative strategies for HIV cure are in development and research studies are being designed and planned globally. South Africa is no exception. However, little is known about stakeholders’ knowledge, understanding and expectations of future cure research. This study aimed to obtain in-depth qualitative insights into stakeholder perspectives at this formative stage of HIV cure research. Fifteen stakeholders were interviewed in an HIV research clinic in the Western Cape, South Africa with their consent. Interviews were transcribed verbatim and analysed using thematic content analysis. Broad themes that emerged included the meaning of cure, awareness of HIV cure research, risks and benefits of such research. General awareness and understanding of HIV cure research was lower than expected. Some participants expressed a fatalistic attitude to HIV and described it as an “end-time illness” with no prospect of cure. In general, HIV cure research was regarded as risky – biologically psychologically and socially. If study designs were to include treatment interruption, participants would comply only if success was guaranteed. Given these perceptions of HIV cure research, significant challenges to consent processes and participant recruitment can be anticipated. Authentic community engagement and intensive educational interventions will be necessary prior to future cure research in South Africa. [ABSTRACT FROM PUBLISHER]

Although clinical research in oncology is vital to improve current understanding of cancer and to validate new treatment options, voluntary informed consent is a critical component. Oncology research participants are a particularly vulnerable population; hence, therapeutic misconception often leads to ethical and legal challenges. We conducted a qualitative study administering semi-structured questionnaires on 29 adult, Phase 3, oncology clinical trial participants at three different private oncology clinical trial sites in South Africa. A descriptive content analysis was performed to identify perceptions of these participants regarding Phase 3 clinical trials. We found that most participants provided consent to be included in the trial for self-benefit. More than half of the participants had a poor understanding of Phase 3 clinical trials, and almost half the participants believed the clinical trial did not pose any significant risk to them. The word “hope” was used frequently by participants, displaying clear optimism with regard to the clinical trial and its outcome. This indicated that therapeutic misconception does occur in the South African oncology research setting and has the potential to lead to underestimation of the risks of a Phase 3 clinical trial. Emphasizing the experimental nature of a clinical trial during the consent process is critical to address therapeutic misconception in oncology research. [ABSTRACT FROM AUTHOR]

The article focuses on history of medicine in terms of dual loyalties, human rights violations, and physician complicity in apartheid South Africa.

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. [ABSTRACT FROM AUTHOR]

The apartheid ideology in South Africa had a pervasive influence on all levels of education including medical undergraduate training. The role of the health sector in human rights abuses during the apartheid era was highlighted in 1997 during the Truth and Reconciliation Commission hearings. The Health Professions Council of South Africa (HPCSA) subsequently realised the importance of medical ethics education and encouraged the introduction of such teaching in all medical schools in the country. Curricular reform at the University of Stellenbosch in 1999 presented an unparalleled opportunity to formally introduce ethics teaching to undergraduate students. This paper outlines the introduction of a medical ethics programme at the Faculty of Health Sciences from 2003 to 2006, with special emphasis on the challenges encountered. It remains one of the most comprehensive undergraduate medical ethics programmes in South Africa. However, there is scope for expanding the curricular time allocated to medical ethics. Integrating the curriculum both horizontally and vertically is imperative. Implementing a core curriculum for all medical schools in South Africa would significantly enhance the goals of medical education in the country. [ABSTRACT FROM AUTHOR]

Trial participation in the proposed HIV Vaccine Trials in South Africais discussed in the context of the ethical tension that exists between internationalethical research standards and local standards of care and cultural normsin the Third World. The important concepts of informed consent, risk-benefitratio and fair treatment of trial participants are interpreted differentlyin traditional, rural African communities, where a moderate form of communitarianismreferred to as “ Ubuntu ” or “communalism”is still prevalent. Research is an altruistic endeavor that benefits communitiesand societies as a result of risks taken by individuals. Universal ethicalguidelines that are highly individualistic and fail to emphasize communalismmay represent serious problems for the sort of research needed in Africa today. [ABSTRACT FROM AUTHOR]

South African research ethics committees (RECs) faced significant challenges during the COVID-19 pandemic. Research ethics committees needed to find a balance between careful consideration of scientific validity and ethical merit of protocols, and review with the urgency normally associated with public health emergency research. We aimed to explore the views of South African RECs on their pandemic preparedness and response during COVID-19. We conducted in-depth interviews with 21 participants from RECs that were actively involved in the review of COVID-19 related research, at seven academic institutions across South Africa. Interviews were conducted remotely using an in-depth interview guide that included questions regarding REC preparedness and response to COVID-19. Interviews were conducted until data saturation, and audio-recordings were transcribed verbatim and coded. An inductive approach to thematic analysis was used to organise data into themes and sub-themes. This study focused on three main themes: coping during COVID-19, building REC capacity during pandemic times and a consistently cautious approach to mutual recognition of REC reviews. Despite an initial sense of unpreparedness, RECs were able to adapt and maintain careful ethical oversight of both COVID and non-COVID research, and the rigour of REC reviews. Several important lessons for preparedness and response to future pandemics were identified, including heightened awareness of publication, funding and political pressures, the importance of regular training for RECs and researchers, and strategies to enhance moral resilience of REC members. Incremental steps are needed to build trust and authentic partnerships among RECs in inter-pandemic times, to facilitate collaboration during future public health emergencies. [ABSTRACT FROM AUTHOR]

The article discusses poor access to bioethics literature in leading journals for low- and middle-income countries (LMICs). It states that lack of access to bioethics literature to LMICs not only prevents the flourishing of a global bioethics but also is unfair to LMICs wanting to pursue a career in the field. Details related to the challenges facing the LMICs to accessing the bioethics literature are also discussed.

Although digital health promotion (DHP) technologies for young people are increasingly available in low- and middle-income countries (LMICs), there has been insufficient research investigating whether existing ethical and policy frameworks are adequate to address the challenges and promote the technological opportunities in these settings. In an effort to fill this gap and as part of a larger research project, in November 2022, we conducted a workshop in Cape Town, South Africa, entitled 'Unlocking the Potential of Digital Health Promotion for Young People in Low- and Middle-Income Countries'. The workshop brought together 25 experts from the areas of digital health ethics, youth health and engagement, health policy and promotion and technology development, predominantly from sub-Saharan Africa (SSA), to explore their views on the ethics and governance and potential policy pathways of DHP for young people in LMICs. Using the World Café method, participants contributed their views on (i) the advantages and barriers associated with DHP for youth in LMICs, (ii) the availability and relevance of ethical and regulatory frameworks for DHP and (iii) the translation of ethical principles into policies and implementation practices required by these policies, within the context of SSA. Our thematic analysis of the ensuing discussion revealed a willingness to foster such technologies if they prove safe, do not exacerbate inequalities, put youth at the center and are subject to appropriate oversight. In addition, our work has led to the potential translation of fundamental ethical principles into the form of a policy roadmap for ethically aligned DHP for youth in SSA. [ABSTRACT FROM AUTHOR]

The author looks at the ethical challenges arising from generalist medicine particularly in South Africa. She explains the difficult relationship between specialists and generalists. She tackles how the application of evidence-based medicine (EBM) principles in clinical practice can be challenging. She also tackles the ethical aspects of health professionals' use of social media and electronic health records.

The article focuses on data governance and data sharing practices among researchers and scientists in sub-Saharan Africa. Topics include the willingness to share data, the importance of robust governance frameworks, and the need for capacity development in data governance for researchers and scientists in the region.

The article focuses on data governance challenges in the context of big data and research ethics committees (RECs) in sub-Saharan Africa (SSA). Topics include the complexity of data sharing and privacy protection, the role of RECs in reviewing data-intense research protocols, and the need for improved guidelines and regulations for big data research in SSA.

The article focuses on the use of cell phone data for tracking human mobility patterns to improve public health in sub-Saharan Africa. Topics include the rising adoption of smartphones and mobile health initiatives, the ethical challenges of using cell phone data for research purposes, and the issues of bias and representativeness in mobility data.

Background: Genetics and genomics research (GGR) is associated with several challenges including, but not limited to, methods and implications of sharing research findings with participants and their family members, issues of confidentiality, and ownership of data obtained from samples. Additionally, GGR holds significant potential risk for social and psychological harms. Considerable research has been conducted globally, and has advanced the debate on return of genetic and genomics testing results. However, such investigations are limited in the African setting, including Uganda where research ethics guidance on return of results is deficient or suboptimal at best. The objective of this study was to assess perceptions of grassroots communities on if and how feedback of individual genetics and genomics testing results should occur in Uganda with a view to improving ethics guidance. Methods: This was a cross-sectional study that employed a qualitative exploratory approach. Five deliberative focus group discussions (FGDs) were conducted with 42 participants from grassroots communities representing three major ethnic groupings. These were rural settings and the majority of participants were subsistence farmers with limited or no exposure to GGR. Data were analysed through thematic analysis, with both deductive and inductive approaches applied to interrogate predetermined themes and to identify any emerging themes. NVivo software (QSR international 2020) was used to support data analysis and illustrative quotes were extracted. Results: All the respondents were willing to participate in GGR and receive feedback of results conditional upon a health benefit. The main motivation was diagnostic and therapeutic benefits as well as facilitating future health planning. Thematic analysis identified four themes and several sub-themes including 1) the need-to-know health status 2) paternity information as a benefit and risk; 3) ethical considerations for feedback of findings and 4) extending feedback of genetics findings to family and community. Conclusion: Participation in hypothetical GGR as well as feedback of results is acceptable to individuals in grassroots communities. However, the strong therapeutic and/or diagnostic misconception linked to GGR is concerning given that hopes for therapeutic and/or diagnostic benefit are unfounded. Viewing GGR as an opportunity to confirm or dispute paternity was another interesting perception. These findings carry profound implications for consent processes, genetic counselling and research ethics guidance. Privacy and confidentiality, benefits, risks as well as implications for sharing need to be considered for such feedback of results to be conducted appropriately. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

The article discusses the benefits of the electronic consent in a COVID-19 vaccine implementation trial in South Africa. Topics include participation of healthcare professionals (HCPs) in an online survey to explore their experiences of providing electronic consent for enrolment into the largest implementation trial of a COVID vaccine in South Africa; training of HCPs with access to electronic devices and data; and the use of descriptive analysis to characterise respondents.

Purpose Many research ethics committees (RECs) have been established in low- and middle-income countries (LMICs) in response to increased research in these countries. How well these RECs are functioning remains largely unknown. Our objective was to assess the usefulness of a self-assessment tool in obtaining benchmarking data on the extent to which RECs are in compliance with recognised international standards. Methods REC chairs from several LMICs (Egypt, South Africa and India) were asked to complete an online self-assessment tool for RECs with a maximum score of 200. Individual responses were collected anonymously. Results The aggregate mean score was 137.4±35.8 (~70% of maximum score); mean scores were significantly associated with the presence of a budget (p<0.001), but not with duration of existence, frequency of meetings, or the presence of national guidelines. As a group, RECs achieved more than 80% of the maximum score for the following domains: submission processes and documents received, recording of meeting minutes, criteria for ethical review and criteria for informed consent. RECs achieved less than 80% of the maximum score for the following domains: institutional commitment, policies and procedures of the REC, membership composition and training, policies and procedures for protocol review, elements of a decision letter and criteria for continuing review. Conclusions This study highlights areas where RECs from LMICs can improve to be in compliance with recommended international standards for RECs. The self-assessment tool provides valuable benchmarking data for RECs and can serve as a quality improvement method to help RECs enhance their operations. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Informed consent is an essential prerequisite for enrolling patients into a study. Obtaining informed consent in an emergency is complex and often impossible. Delayed consent has been suggested for emergency care research. This study aims to determine the acceptability of prehospital emergency care research with delayed consent in the Western Cape community of South Africa. Methods: This study was an online survey of a stratified, representative sample of community members in the Western Cape province of South Africa. We calculated a powered sample size to be 385, and a stratified sampling method was employed. The survey was based on similar studies and piloted. Data were analysed descriptively. Results: A total of 807 surveys were returned. Most respondents felt that enrolment into prehospital research would be acceptable if it offered direct benefit to them (n = 455; 68%) or if their condition was life-threatening and the research would identify improved treatment for future patients with a similar condition (n = 474; 70%). Similar results were appreciable when asked about the participation of their family member (n = 445; 66%) or their child (n = 422; 62%) regarding direct prospects of benefit. Overwhelmingly, respondents indicated that they would prefer to be informed of their own (n = 590; 85%), their family member's (n = 593; 84%) or their child's (n = 587; 86%) participation in a study immediately or as soon as possible. Only 35% (n = 283) agreed to retention data of deceased patients without the next of kin's consent. Conclusion: We report majority agreement of respondents for emergency care research with delayed consent if the interventions offered direct benefit to the research participant, if the participant's condition was life-threatening and the work held the prospect of benefit for future patients, and if the protocol for delayed consent was approved by a human research ethics committee. These results should be explored using qualitative methods. [ABSTRACT FROM AUTHOR]

The massive growth in global health research in past decades has posed many challenges for its effective ethical oversight, not least of which is how best to provide effective protection of research participants. The extent of the HIV epidemic in sub-Saharan Africa in particular makes research into prevention technologies for HIV, including HIV vaccine research, a global priority. However, the need for vaccine research must be considered in conjunction with the individual's right to informed consent, which is based on the principle of respect for autonomy. One of the primary human rights violations likely to occur in the context of HIV vaccine research is that potential research participants may not fully understand what participation in research studies entails. People who elect to enrol in HIV vaccine trials are required to understand both the potential negative effects of participation (eg, discrimination) as well as complex scientific concepts such as randomisation and prophylaxis in order to be ethically enrolled. In this study, two vignettes are presented to illustrate two core issues in conducting phase III HIV vaccine trials in low-income countries-namely, (1) from the perspective of participants, the extent to which understanding is a prerequisite for consenting to participate in a trial, and (2) from the perspective of trial investigators, whether it is appropriate to persuade eligible people to enrol in a trial, even though their initial reaction is to decline to participate. These vignettes are used to analyse these issues through the prisms of research ethics and human rights in order to identify helpful synergies. It is argued that the human rights perspective provides a helpful lens on ethical issues. [ABSTRACT FROM AUTHOR]

Genomic research and the biobanking capacity it requires are experiencing considerable growth on the continent of Africa. However genomic research and biobanking raise a range of legal, ethical, social, and cultural issues, including concerns about broad consent, confidentiality, community stigmatization, discrimination, indefinite storage, and long-term use. There is a need to establish governance frameworks that address these issues, and many international health research ethics and biobanking guidelines now recommend that the best way to do so is by involving potential research participants and key community stakeholders in the research development and the process of acquiring samples and data through active community engagement (CE). This article describes the experience and challenges in developing an educational tool as part of a CE initiative in South Africa and the commentaries reflect on how this process may be improved going forward. [ABSTRACT FROM AUTHOR]

The article discusses the Academy of Science of South Africa's (ASSAf) study about the ethical, legal and social implications (ELSI) of human genetics and genomics work in the country. Topics discussed include the thematic areas of the study such as building relationships, respect for persons and good stewardship, the recommendations to develop human capacity and material resources, and the call for the appropriate training of healthcare professionals in genetics and genomics.

This paper reports the results of a workshop held in January 2013 to begin the process of establishing standards for e-learning programmes in the ethics of research involving human participants that could serve as the basis of their evaluation by individuals and groups who want to use, recommend or accredit such programmes. The standards that were drafted at the workshop cover the following topics: designer/provider qualifications, learning goals, learning objectives, content, methods, assessment of participants and assessment of the course. The authors invite comments on the draft standards and eventual endorsement of a final version by all stakeholders. [ABSTRACT FROM AUTHOR]

The article offers information on optimistic vision for biosciences in South Africa including interests and rights of both the individual and the collective which are related to autonomy and privacy.