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.
This special issue of the South African Journal of Science on 'Big data and AI in health sciences research in subSaharan Africa' comes from within a large-scale initiative, sponsored by the US ...National Institutes of Health, to promote research use of 'big data' for health promotion in Africa. As stated on its website (https://dsi-africa.org), the Data Science for Health Discovery and Innovation in Africa (DS-I Africa) Initiative aims to leverage data science technologies to transform biomedical and behavioural research and develop solutions that would lead to improved health for individuals and populations. Started in 2021, DS-I Africa has the ambitious goals of creating pan-African scientific networks; developing data science centres of excellence; creating new data collection and analytic systems, applications and tools; facilitating data resource access to the global scientific community; and advancing policies in Africa related to ethical issues raised by data science. A notable structural feature of DS-I Africa is the intentional pairing of specific scientific projects (or 'data hubs') with projects focusing on the ethical, legal and social implications (or ELSI) of data science. While this embedding of ELSI projects within large scientific initiatives in Africa is by no means new - it was also a feature of the H3Africa initiative (https://h3africa.org) - it does raise some complex questions about the relationships between social science, ethics, law and the scientific pursuit of knowledge through digital technologies in the context of global, regional and domestic inequities. Africa is, albeit unevenly in some regions, undergoing an accelerated process of data digitisation. Increased access to and use of the Internet, personal computers and mobile devices in Africa, as well as advances in data storage and transfer capacity, means that individuals, communities and environments are becoming more 'visible' to researchers, and with this new visibility comes the potential for improved understanding and more effective health interventions. In principle, this digital (r)evolution should be warmly welcomed by adherents to evidence-based medicine and public health. For decades, there have been complaints about a 'data vacuum' in Africa, which has hampered efforts to provide effective clinical care, conduct rigorous scientific research, strengthen fragile health systems and tackle emerging public health threats. The pendulum, it seems, is starting to move in the opposite direction, with massive volumes of health-related data in sub-Saharan Africa being collected, analysed, stored, shared and utilised by numerous stakeholders. But while scarcity of data constituted a problem, so too does an abundance.
Biobanking provides exciting opportunities for research on stored biospecimens. However, these opportunities to advance medical science are fraught with challenges including ethical and legal ...dilemmas. This study was undertaken to establish perspectives of South African stakeholders on the ethico-legal dimensions of biobanking. An in-depth exploratory study was conducted with 25 purposively selected biobankers, clinicians, researchers, postgraduate students in biobanking research, and research ethics committee (REC) members in South Africa. Potential study participants were recruited through known hubs for biobanking in the country, online searches and the snowball sampling technique. A semi-structured face-to-face or Skype interview was arranged. Data was analysed using thematic analysis. The emergent themes included: inconsistency in understanding consent models, disconnect between biobank researchers and biosample donors, inadequate processes to support re-consenting minors, inconsistent governance processes for biobanking research; challenges with sample and data sharing, and suboptimal strategies for benefit sharing and return of results. Biobanking practice in general appeared to be inconsistent and fragmented. While the need for consent in research is explicitly outlined in legislative documents, some respondents were unclear on the type of consent model to apply in biosample collection. They also reported inconsistencies in research participants' understanding of consent. Furthermore, these respondents' own understanding of consent and consent models were dependent on where they were positioned in biobanking practice (roles occupied). Respondents were unsure about the process to follow to re-consent child participants once the age of majority (greater than or equai to 18 years) was reached. It was not surprising that consent was identified as one of the major ethical challenges in biobanking practice. In certain settings, some respondents reported suboptimal governance processes for sample collection. Participants were generally unsure about how to operationalise benefit sharing and how to approach the idea of returning results to research participants and biobank donors. The study findings indicated inconsistencies in stakeholder understanding of ethico-legal considerations related to biobanking in South Africa. A need for ongoing ethics capacity development among stakeholders was identified. Improving understanding of the ethics of biobanking could be facilitated by acknowledging the disconnect created by biosamples in the relationship between biobank researchers and donors.
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.
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.
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.
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.
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.
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.
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.
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.
The COVID-19 pandemic presents significant challenges to research ethics committees (RECs) in balancing urgency of review of COVID-19 research with careful consideration of risks and benefits. In the ...African context, RECs are further challenged by historical mistrust of research and potential impacts on COVID-19 related research participation, as well as the need to facilitate equitable access to effective treatments or vaccines for COVID-19. In South Africa, an absent National Health Research Ethics Council (NHREC) also left RECs without national guidance for a significant duration of the COVID-19 pandemic. We conducted a qualitative descriptive study that explored the perspectives and experiences of RECs regarding the ethical challenges of COVID-19 research in South Africa.
We conducted in-depth interviews with 21 REC chairpersons or members from seven RECs at large academic health institutions across South Africa that were actively involved in the review of COVID-19 related research from January to April 2021. In-depth interviews were conducted remotely via Zoom. Interviews (60-125 min) were conducted in English using an in-depth interview guide, until data saturation was achieved. Audio-recordings were transcribed verbatim and field notes were converted into data documents. Line-by-line coding of transcripts was performed, and data were organised into themes and sub-themes. An inductive approach to thematic analysis was used to analyse data.
Five main themes were identified, namely: rapidly evolving research ethics landscape, extreme vulnerability of research participants, unique challenges to informed consent, challenges to community engagement during COVID-19, and overlapping research ethics and public health equity issues. Sub-themes were identified for each main theme.
Numerous, significant ethical complexities and challenges were identified by South African REC members in the review of COVID-19 related research. While RECs are resilient and adaptable, reviewer and REC member fatigue were major concerns. The numerous ethical issues identified also highlight the need for research ethics teaching and training, especially in informed consent, as well as the urgent requirement for the development of national guidelines for research ethics during public health emergencies. Further, comparative analysis between different countries is needed to develop the discourse around African RECs and COVID-19 research ethics issues.
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.
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.
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.
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.
Compensation for research related injuries is a subject that is increasingly gaining traction in developing countries which are burgeoning destinations of multi center research. However, the ...existence of disparate compensation rules violates the ethical principle of fairness. The current paper presents a comparison of the policies of Brazil, Russia, India, China and South Africa (BRICS).
A systematic search of good clinical practice guidelines was conducted employing search strategies modeled in line with the recommendations of ADPTE Collaboration (2007). The search focused on three main areas namely bibliographic data bases, clinical practice guidelines data bases and a restricted internet search. A manual search of references cited in relevant guideline documents was also conducted. The search terms, Medical Subject Headings (MeSH) and key words were developed for a PubMed platform and then adapted for all other data bases. The search terms were kept constant for each country with the only difference being the country name. The documents so obtained were subjected to systematic content analysis.
The study revealed that there is vast panoply of regulations which exist on a continuum. On one extreme is India with comprehensive regulations that are codified into law, and on the other end there is China which does not have specific laws regulating research related injuries. There are a number of differences and similarities such as mandatory insurance requirements, existence of no fault compensation, compensable injuries and the role of research ethics committees.
It is imperative to enact legislations that protect participants without stifling the research enterprise. There is need for consistency and ideally harmonization of such regulations at a global level. A model policy on compensation for research related injuries should borrow from the best aspects of the different country policies and should be informed by the cardinal ethics principles of autonomy, justice and beneficence.
Genomic biobanking research is undergoing exponential growth in Africa raising a host of legal, ethical and social issues. Given the scientific complexity associated with genomics, there is a growing ...recognition globally of the importance of science translation and community engagement (CE) for this type of research, as it creates the potential to build relationships, increase trust, improve consent processes and empower local communities. Despite this level of recognition, there is a lack of empirical evidence of the practise and processes for effective CE in genomic biobanking in Africa.
To begin to address this vacuum, 17 in-depth face to face interviews were conducted with South African experts in genomic biobanking research and CE to provide insight into the process, benefits and challenges of CE in South Africa. Emerging themes were analysed using a contextualised thematic approach.
Several themes emerged concerning the conduct of CE in genomic biobanking research in Africa. Although the literature tends to focus on the local community in CE, respondents in this study described three different layers of stakeholder engagement: community level, peer level and high level. Community level engagement includes potential participants, community advisory boards (CAB) and field workers; peer level engagement includes researchers, biobankers and scientists, while high level engagement includes government officials, funders and policy makers. Although education of each stakeholder layer is important, education of the community layer can be most challenging, due to the complexity of the research and educational levels of stakeholders in this layer.
CE is time-consuming and often requires an interdisciplinary research team approach. However careful planning of the engagement strategy, including an understanding of the differing layers of stakeholder engagement, and the specific educational needs at each layer, can help in the development of a relationship based on trust between the research team and various stakeholder groups. Since the community layer often comprises vulnerable populations in low and middle income countries (LMICs), co-development of innovative educational tools on genomic biobanking is essential. CE is clearly a component of a broader process best described as stakeholder engagement.
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