Digital tools for youth health promotion: principles, policies and practices in sub-Saharan Africa.

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.

Awareness, experiences and perceptions regarding genetic testing and the return of genetic and genomics results in a hypothetical research context among patients in Uganda: a qualitative study.

BACKGROUND: Genetic testing presents unique ethical challenges for research and clinical practice, particularly in low-resource settings. To address such challenges, context-specific understanding of ethical, legal and social issues is essential. Return of genetics and genomics research (GGR) results remains an unresolved yet topical issue particularly in African settings that lack appropriate regulation and guidelines. Despite the need to understand what is contextually acceptable, there is a paucity of empirical research and literature on what constitutes appropriate practice with respect to GGR.The study assessed patients' awareness, experiences and perceptions regarding genetic testing and the return of GGR results in a hypothetical context. METHODS: This cross-sectional study employed a qualitative exploratory approach. Respondents were patients attending the medical outpatient unit of Mulago National Hospital. Three deliberative focus group discussions involving 18 respondents were conducted. Data were analysed through thematic analysis. RESULTS: Three main themes and several subthemes were identified. Most respondents were aware of genetic testing, supportive of GGR and receiving results. However, only a few had undergone genetic testing due to cost constraints. They articulated the need for adequate information and genetic counselling to inform decision-making. Privacy of results was important to respondents while others were willing to share results. CONCLUSION: There was general awareness and support for GGR and the return of results. Stigmatisation emerged as a barrier to disclosure of results for some. Global health inequity impacts access and affordability of genetic testing and counselling in Africa and should be addressed as a matter of social justice.

Key ethical issues encountered during COVID-19 research: a thematic analysis of perspectives from South African research ethics committees.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Research-Related Stakeholders' Perspectives on Sociocultural Considerations in Biobanking Practice in South Africa.

Background: Biobanking practice continues to proliferate in South Africa, yet little is known about how stakeholders engage with social, cultural, and religious considerations in this area of research. This study was undertaken to establish the perspectives of South African stakeholders (researchers, biobankers, clinicians, and research committee members) on sociocultural considerations in biobanking research. Methods: This in-depth exploratory study used semistructured face-to-face or Skype interviews with 25 purposively selected stakeholders involved in the biobanking-related practice. The study sample comprised biobankers, clinicians, researchers, postgraduate students in biobanking research, and research ethics committee members in South Africa. The interview focused on social and cultural challenges facing the biobanking practice in the country. Further probes included stakeholder perspectives on ownership and custodianship of stored biosamples. Thematic analysis was used to analyze the collected data. Results and Discussion: Several themes arose from the data analysis. These included respondents' perceptions of poor understanding of biobanking among research participants and communities; inconsistency in defining ownership and custodianship of biosamples; variability in respondents' understanding of cultural, religious, and social implications of biobanking; the notion of distrust; and building trust in biobanking. There were also inconsistencies in respondents' recognition of social, cultural, and/or religious influences on participant decision-making in biobanking research. Respondents highlighted that a general climate of distrust existed in the biobanking practice in South Africa. Conclusion: There is a need for greater stakeholder awareness of sociocultural considerations in biobanking practice in South Africa. One possible way to achieve this could be through the availability of training programs aimed at improving stakeholder understanding of the sociocultural context for biobanking practice in addition to greater efforts at community engagement with respect to all biobanking activities and research.

Feedback of individual genetic and genomics research results: A qualitative study involving grassroots communities in Uganda.

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.

Ethics and governance challenges related to genomic data sharing in southern Africa: the case of SARS-CoV-2.

Data sharing in research is fraught with controversy. Academic success is premised on competitive advantage, with research teams protecting their research findings until publication. Research funders, by contrast, often require data sharing. Beyond traditional research and funding requirements, surveillance data have become contentious. Public health emergencies involving pathogens require intense genomic surveillance efforts and call for the rapid sharing of data on the basis of public interest. Under these circumstances, timely sharing of data becomes a matter of scientific integrity. During the COVID-19 pandemic, the transformative potential of genomic pathogen data sharing became obvious and advanced the debate on data sharing. However, when the genomic sequencing data of the omicron (B.1.1.529) variant was shared and announced by scientists in southern Africa, various challenges arose, including travel bans. The scientific, economic, and moral impact was catastrophic. Yet, travel restrictions failed to mitigate the spread of the variant already present in countries outside Africa. Public perceptions of the negative effect of data sharing are detrimental to the willingness of research participants to consent to sharing data in postpandemic research and future pandemics. Global health governance organisations have an important role in developing guidance on responsible sharing of genomic pathogen data in public health emergencies.

The acceptability of delayed consent for prehospital emergency care research in the Western Cape province of South Africa.

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.

Challenges to biobanking in LMICs during COVID-19: time to reconceptualise research ethics guidance for pandemics and public health emergencies?

Biobanking can promote valuable health research that may lead to significant societal benefits. However, collecting, storing and sharing human samples and data for research purposes present numerous ethical challenges. These challenges are exacerbated when the biobanking efforts aim to facilitate research on public health emergencies and include the sharing of samples and data between low/middle-income countries (LMICs) and high-income countries (HICs). In this article, we explore ethical challenges for COVID-19 biobanking, offering examples from two past infectious disease outbreaks in LMICs where biobanking activities contributed to the perpetuation of global inequities. We focus on how the ethical imperative to promote the common good during public health emergencies can conflict with protecting the interests of biobank participants. We discuss how conducting biobank research under a waiver of informed consent during public health emergencies is ethically permissible, provided guidance is in place to prevent biopiracy and exploitation of vulnerable communities. We also highlight the need for biobank collaborations between LMICs and HICs to promote capacity building and benefit sharing. Finally, we offer guidance to promote the ethical oversight of biobanks and biobank research during the COVID-19 pandemic or other future public health emergencies.

Online Training as a Means to Improve the Understanding of Ethical, Legal, and Social Aspects of Biobanking Research: Stakeholder Perspectives from South Africa.

Introduction: The proliferation of biobanking activities demand a review of current training opportunities for service providers and researchers, specifically related to the ethical, legal, and social issues (ELSI) of biobanking research. Such information could be useful for planning and developing an educational course. However, it is equally important to explore the platform for offering such a course. Aim and Objectives: This study explored stakeholder perspectives on training needs in biobanking research and the use of an online training platform for such educational purposes. Methods: An exploratory study design using qualitative data was used. The study sample comprised selected stakeholders (n = 25) including biobankers, clinicians, researchers, postgraduate students, and research ethics committee members. Semi-structured in-person or Skype interviews were conducted and all ethical considerations were upheld. The interview focused on participants' perspectives on the accessibility and applicability of current available courses, and advantages and disadvantages of online biobanking courses. Data were analyzed using thematic analysis. Results and Discussion: The following themes arose from data analysis: inadequate availability of online courses, and advantages and disadvantages of online courses and opportunities for a successful training course. There was general consensus regarding the limited availability of context-specific training opportunities on the ELSI of biobanking. The majority of participants were previously self-taught and therefore relied on existing literature and collaborations with international biobanking groups for ongoing learning. Some respondents indicated that the costs of such available training courses were exorbitant. Some respondents also felt that available courses were not tailored to the specific needs of a diverse audience in biobanking. Apart from access, respondents reported possible challenges with internet connectivity and availability of data. Conclusion: Respondents expressed a need for affordable and focused online educational opportunities in biobanking, but highlighted that these courses need to be contextualized and integrated into other learning activities.

Liver transplantation for non-resectable colorectal liver metastases: the International Hepato-Pancreato-Biliary Association consensus guidelines.

Colorectal cancer is a prevalent disease worldwide, with more than 50% of patients developing metastases to the liver. Despite advances in improving resectability, most patients present with non-resectable colorectal liver metastases requiring palliative systemic therapy and locoregional disease control strategies. There is a growing interest in the use of liver transplantation to treat non-resectable colorectal liver metastases in well selected patients, leading to a surge in the number of studies and prospective trials worldwide, thereby fuelling the emerging field of transplant oncology. The interdisciplinary nature of this field requires domain-specific evidence and expertise to be drawn from multiple clinical specialities and the basic sciences. Importantly, the wider societal implication of liver transplantation for non-resectable colorectal liver metastases, such as the effect on the allocation of resources and national transplant waitlists, should be considered. To address the urgent need for a consensus approach, the International Hepato-Pancreato-Biliary Association commissioned the Liver Transplantation for Colorectal liver Metastases 2021 working group, consisting of international leaders in the areas of hepatobiliary surgery, colorectal oncology, liver transplantation, hepatology, and bioethics. The aim of this study was to standardise nomenclature and define management principles in five key domains: patient selection, evaluation of biological behaviour, graft selection, recipient considerations, and outcomes. An extensive literature review was done within the five domains identified. Between November, 2020, and January, 2021, a three-step modified Delphi consensus process was undertaken by the workgroup, who were further subgrouped into the Scientific Committee, Expert Panel, and Transplant Centre Representatives. A final consensus of 44 statements, standardised nomenclature, and a practical management algorithm is presented. Specific criteria for clinico-patho-radiological assessments with molecular profiling is crucial in this setting. After this, the careful evaluation of biological behaviour with bridging therapy to transplantation with an appropriate assessment of the response is required. The sequencing of treatment in synchronous metastatic disease requires special consideration and is highlighted here. Some ethical dilemmas within organ allocation for malignant indications are discussed and the role for extended criteria grafts, living donor transplantation, and machine perfusion technologies for non-resectable colorectal liver metastases are reviewed. Appropriate immunosuppressive regimens and strategies for the follow-up and treatment of recurrent disease are proposed. This consensus guideline provides a framework by which liver transplantation for non-resectable colorectal liver metastases might be safely instituted and is a meaningful step towards future evidenced-based practice for better patient selection and organ allocation to improve the survival for patients with this disease.

COVID-19 underscores the important role of Clinical Ethics Committees in Africa.

BACKGROUND: The COVID-19 pandemic has magnified pre-existing challenges in healthcare in Africa. Long-standing health inequities, embedded in the continent over centuries, have been laid bare and have raised complex ethical dilemmas. While there are very few clinical ethics committees (CECs) in Africa, the demand for such services exists and has increased during the COVID-19 pandemic. The views of African healthcare professionals or bioethicists on the role of CECs in Africa have not been explored or documented previously. In this study, we aim to explore such perspectives, as well as the challenges preventing the establishment of CECs in Africa. METHODS: Twenty healthcare professionals and bioethicists from Africa participated in this qualitative study that utilized in-depth semi-structured interviews with open-ended questions. Themes were identified through thematic analysis of interviews and open-ended responses. RESULTS: Kenya and South Africa are the only countries on the continent with formal established CECs. The following themes emerged from this qualitative study: (1) Lack of formal CECs and resolution of ethical dilemmas; (2) Role of CECs during COVID-19; (3) Ethical dilemmas presented to CECs pre-COVID-19; (4) Lack of awareness of CECs; (5) Lack of qualified bioethicists or clinical ethicists; (6) Limited resources to establish CECs; (7) Creating interest in CECs and networking. CONCLUSIONS: This study illustrates the importance of clinical ethics education among African HCPs and bioethicists, more so now when COVID-19 has posed a host of clinical and ethical challenges to public and private healthcare systems. The challenges and barriers identified will inform the establishment of CECs or clinical ethics consultation services (CESs) in the region. The study results have triggered an idea for the creation of a network of African CECs.

Stakeholder perspectives on the ethico-legal dimensions of biobanking in South Africa.

BACKGROUND: 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. METHODS: 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. RESULTS: 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 (≥ 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. CONCLUSION: 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.

Allocation of scarce resources in Africa during COVID-19: Utility and justice for the bottom of the pyramid?

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.

Allegations of misuse of African DNA in the UK: Will data protection legislation in South Africa be sufficient to prevent a recurrence?

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.

Clinical Ethics Committees in Africa: lost in the shadow of RECs/IRBs?

BACKGROUND: Clinical Ethics Committees (CECs) are well established at healthcare institutions in resource-rich countries. However, there is limited information on established CECs in resource poor countries, especially in Africa. This study aimed to establish baseline data regarding existing formal CECs in Africa to raise awareness of and to encourage the establishment of CECs or Clinical Ethics Consultation Services (CESs) on the continent. METHODS: A descriptive study was undertaken using an online questionnaire via SunSurveys to survey healthcare professionals and bioethicists in Africa. Data were subjected to descriptive analysis and Fischer's exact test was applied to determine associations. Texts from the open-ended questions were thematically analysed. RESULTS: In total 109 participants from 37 African countries completed the survey in December 2019. A significant association was found between participants' bioethics qualification or training and involvement in clinical ethics (p = 0.005). All participants were familiar with Research Ethics Committees (RECs), and initially conflated RECs with CECs. When CECs were explained in detail, approximately 85.3% reported that they had no formal CECs in their institutions. The constraints to developing CECs included lack of training, limited resources, and lack of awareness of CECs. However, the majority of participants (81.7%) were interested in establishing CECs. Participants listed assistance required in establishing CECs including funding, resources, capacity building and collaboration with other known CECs. The results do not reflect CECs established since the onset of COVID-19 in Africa. CONCLUSIONS: This study provides a first look into CECs in Africa and found very few formal CECs on the continent indicating an urgent need for the establishment of CECs or CESs in Africa. While the majority of healthcare professionals and bioethicists are aware of ethical dilemmas in healthcare, the concept of formal CECs is foreign. This study served to raise awareness of CECs. Research ethics and RECs overshadow CECs in Africa because international funders from the global north support capacity development in research ethics and establish RECs to approve the research they fund in Africa. Raising awareness via educational opportunities, research and conferences about CECs and their role in improving the quality of health care in Africa is sorely needed.

What Could "Fair Allocation" during the Covid-19 Crisis Possibly Mean in Sub-Saharan Africa?

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.