International collaborative research in Africa has raised ethical challenges for decades. The proposed newborn hepatitis B vaccine trial in Guinea-Bissau is the latest case to crystallise concerns around potential exploitation of disadvantaged populations, drawing comparisons to Tuskegee and other research abuses. We argue that the decision to stop the trial was appropriate, but that the reasons most invoked in public debate are incomplete. The trial was designed to happen during a defined window before Guinea-Bissau's planned rollout of the universal birth-dose vaccination in 2027-28, when randomisation between the WHO-recommended birth dose and the existing local standard of care remained possible. Under what conditions, if any, could such research-comparing a local versus global standard of care during health policy transition-be ethically justified? We propose four conditions and assess the proposed trial against them. The trial potentially satisfies some of our proposed conditions but does not meet others owing to an absence of maternal hepatitis B screening despite high background prevalence, methodological shortcomings that threaten the interpretability of results, and governance deficiencies, including an absence of sponsor-country ethics review (required by the Declaration of Helsinki). We treat this trial as a cautionary tale offering important lessons for future research in low-resource settings undergoing policy transitions.

Large multimodal models, a type of generative artificial intelligence (AI), could contribute to wider government efforts to achieve universal health coverage if ethical challenges are proactively addressed during the design and deployment of these AI technologies. The World Health Organization has published new guidance to highlight the risks and benefits of large multimodal models and recommendations to effectively govern this technology.

The health research landscape in southern Africa is becoming increasingly complex as research efforts intensify to address the region's significant disease burden. The increasing volume and complexity of health research in low- and middle-income countries (LMICs) highlights the ongoing need for enhanced research ethics capacity. To supplement a review published in 2014, this paper provides an overview of research ethics capacity-building initiatives supported through substantive long-term competitive awards from the Fogarty International Center of the US National Institutes of Health between 2014 and 2024. These programs aimed to enhance the capabilities of research ethics committees (RECs) and strengthen research ethics capacity throughout Southern Africa, with broader benefits to the African continent and globally as collaborative health research increases. The programs have successfully developed and delivered comprehensive research ethics curricula tailored to research ethics concerns in the region. Trainees and graduates include clinicians, researchers, REC members, REC administrators, lawyers, and ethicists, with focused efforts to ensure gender parity. This increased representivity of scholars has improved the membership on RECs and in skilled research ethics leadership in the region. For the benefit of future planning, this paper also describes some of the many challenges faced in delivering on program goals - including COVID-19. We also describe innovative solutions developed to address these challenges and meet the needs of students, faculty and institutions, while cultivating excellence in health research ethics. The paper concludes by highlighting areas for future research, underscoring the importance of continued diverse global investment in research ethics capacity to protect research participants and maintain and improve ethical standards and practice in health research within the region and globally. This will enable the development of innovative evidence-based global health solutions based on ethical research.

This Viewpoint discusses key revisions of the Declaration of Helsinki 2024 in the context of internationally accepted ethical guidance for human research.

The integration of artificial intelligence (AI) into healthcare has transformed patient care through advanced diagnostics, personalized treatment plans, and predictive analytics. However, this technological evolution presents a paradox when juxtaposed with narrative-based medicine (NBM), which emphasizes the patient's story and human experience in healthcare delivery. The integration of AI into the NBM raises questions regarding its clinical applicability, resistance from patients and physicians, emotional considerations, time constraints, and ability to balance psychosocial and biomedical care. This critical review explores the challenges and potential of combining AI with NBM, aiming to enhance patient care by leveraging the strengths of both approaches.

The transfer of biological materials is pivotal in health research, especially in clinical trials conducted in sub-Saharan Africa (SSA). Standard material transfer agreements (MTAs) have been developed to exercise due diligence during the transfer of biological materials. Recent controversial conduct in research in SSA highlights the need for robust regulation, especially concerning biological sample transfer. This study evaluated the sufficiency of Zambia's existing regulations concerning MTAs using the South African regulatory framework as a comparator. A qualitative study approach was adopted utilizing a desk review. Thematic analysis was conducted using relevant, publicly accessible national regulatory documents. All necessary approvals were obtained. Both countries have established provisions for MTAs in health research, although the legal status of the respective provisions differ. Zambia's MTA is based on the National Health Research Act No. 2 of 2013 and mandates that while samples and data remain the property of the Zambian government, research participants must share in future benefits that arise. In contrast, South Africa's MTA (2018) is a framework agreement, outlining the contractual aspects of biological sample sharing in research. It highlights ownership of samples as resting with the "donor," benefit sharing, an ongoing consent process, secondary use of materials and dispute settlement. Both nations emphasize intellectual property rights, privacy with respect to samples and associated data. In Zambia, it is a legal requirement for contracting parties to sign a MTA. Ownership of biological samples vests with the Zambian government. On the other hand, the South African MTA (2018) is regarded as a regulatory framework and is contentious especially with respect to ownership and inclusion of the REC as a contractual party. In both countries, enforcement and implementation remain critical concerns in collaborative research involving sharing of biological samples. Consequently, the MTAs need to be reviewed. Reaching consensus is a research ethics imperative.

While the use of generative artificial intelligence (AI) in research has sparked controversy internationally, the use of large language models (LLMs) in the ethics review of research protocols is particularly contentious. Against this backdrop, Porsdam Mann et al recently published a comprehensive, well-balanced and carefully considered paper on the use of application-specific LLMs by Research Ethics Committees (RECs). Although we support the potential advantages that such curated LLMs can bring in improving the speed and efficiency of REC processes globally, there are some challenges that are unique to resource-constrained settings. While many of these challenges relate to infrastructural constraints, linguistic diversity, paper-based submission systems and the digital divide, substantive concerns are linked to the availability, relevance and quality of training data required for LLMs. Protection of confidential data submitted to RECs over decades is another concern. This is especially important where clinical trials are concerned. Furthermore, RECs in low- and middle-income countries (LMICs) have nuanced and historical considerations relating to research ethics that have arisen in the context of asymmetrical power differentials in international collaborative research. Currently, such considerations are not easily delegated to AI systems. There are also risks, especially automation bias, in contexts where skills development in research ethics review is much needed and progressing well. Mitigating such risks may be possible in the future by implementing various guardrails. However, exploring potentially different ways in which LLMs could be used, especially in improving capacity development of REC members, is critical.

Advancing doctoral and postdoctoral international bioethics training in low-and-middle income countries (LMICs) is essential to address the emerging and reemerging healthcare needs of local populations. The COVID-19 pandemic underscored the need for sustenance of global collaboration and rapid adaptability in the future to further prioritize research frameworks to benefit LMICs. Thus, the purpose of the manuscript is to share the successes, challenges, and future considerations of building bioethics research capacity in seven federally funded training programs supported by the Fogarty International Center of the National Institutes of Health D43 mechanism. We advocate for continued investment in training programs recognizing that it requires committed time and effort, specialized funding opportunities, cultural sensitivity, and interdisciplinary faculty support both domestically and internationally. This investment supports cross-disciplinary collaboration, enhances the ethical conduct of research and recognizes the importance of context-sensitive research that generates evidence-based data for global solutions.

Background:Digital technologies for health promotion have proliferated over the past decade, with uptake increasing steadily among young people, including those in low- and middle-income countries (LMICs). Youth increasingly rely on digital tools for health information, and the early influence of this digital technology can have an impact throughout the lifespan. While there is a growing body of literature on the opportunities and challenges of digital health promotion (DHP) for young people, a gap remains in research that closely examines the characteristics of digital health strategies developed specifically for youth in LMICs. Objective:In this paper, we investigate and compare selected examples of DHP tools from 3 countries in Sub-Saharan Africa, namely Ghana, Kenya, and South Africa. Our aim is to create a multidimensional descriptive typology of DHP tools developed specifically to promote the health of adolescents and young adults in these countries. Methods:To select the tools, we conducted systematic internet-based searches using relevant keywords, incorporating the expertise of local professionals to ensure a thorough search. Included solutions originated from one of the 3 countries of focus and could take any number of forms such as apps, websites, chatbots, or social media initiatives. We thereafter deductively created a typology describing selected features of each tool, including the health area of focus, key stakeholders, type of service, and ethical values explicitly referenced within the tool. While such high-level features of interest were selected based on the existing literature in the field, the detailed descriptive categories were identified through an inductive analysis of the tools. Results:A total of 31 DHP tools were identified. Sexual and reproductive health was the most common health area of focus for DHP services, which were primarily funded and supported by local non-governmental organizations, foundations, and international organizations. The assessed tools were predominantly web-based and social media-based, with the overarching goal and core value of expanding health knowledge and offering access to health promotion services to young people. Conclusions:With sustained investment, DHP can improve the health of young people while relieving pressure on health care services. The areas of mental health, as well as substance use prevention and nutrition, stand out with clear potential for health gains through investment in DHP. Addressing ethical concerns such as privacy, transparency, equity, and inclusiveness is essential to the safety, usefulness, and fairness of DHP. To achieve the greatest benefit, local youth perspectives and priorities should be included in DHP development. Local initiatives have the potential to be the most agile, flexible, and relevant for the target audience of young people, with the overall goal of early intervention and greater health quality throughout the lifespan, and more efficient use of health care resources.

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.

Groundbreaking data-sharing techniques and quick access to stored research data from the African continent are highly beneficial to create diverse unbiased datasets to inform digital health technologies and artificial intelligence in healthcare. Yet health researchers in sub-Saharan Africa (SSA) experience individual and collective challenges that render them cautious and even hesitant to share data despite acknowledging the public health benefits of sharing. This qualitative study reports on the perspectives of health researchers regarding strategies to mitigate these challenges. In-depth interviews were conducted via Microsoft Teams with 16 researchers from 16 different countries across SSA between July 2022 and April 2023. Purposive and snowball sampling techniques were used to invite participants via email. Recorded interviews were transcribed, cleaned, coded and managed through Atlas.ti.22. Thematic Analysis was used to analyse the data. Three recurrent themes and several subthemes emerged around strategies to improve governance of data sharing. The main themes identified were (1) Strategies for change at a policy level: guideline development, (2) Strengthening data governance to improve data quality and (3) Reciprocity: towards equitable data sharing. Building trust is central to the promotion of data sharing amongst researchers on the African continent and with global partners. This can be achieved by enhancing research integrity and strengthening micro and macro level governance. Substantial resources are required from funders and governments to enhance data governance practices, to improve data literacy and to enhance data quality. High quality data from Africa will afford diversity to global data sets, reducing bias in algorithms built for artificial intelligence technologies in healthcare. Engagement with multiple stakeholders including researchers and research communities is necessary to establish an equitable data sharing approach based on reciprocity and mutual benefit.

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.

Africa has a colonial past that renders it a linguistic melting pot, where language is not only important for communication but is inextricably related to cultural identity. In Africa, there are over 2000 languages that are still being used and spoken. Language diversity coupled with cultural diversity may affect the process of obtaining informed consent in data-intensive research. We explore some of the challenges and opportunities of multilingualism in handling informed consent in the context of data-intensive research. In multilingual contexts, as in most African countries, language is exceptionally central, and translation has potential cultural, social, historical, functional and scientific importance. However, it is recognised that terminological and translation activities may not always be cost-effective or feasible. We consider alternative mechanisms of harmonisation of data-related terminology and concepts in multilingual contexts, such as iconography, graphic elicitation and other multimedia formats of information sharing. The inclusion of visual or multimedia explanations in informed consent forms can improve comprehension, enhance information transfer and learning, reduce potential vulnerabilities associated with low literacy levels or the inability to interpret technical language associated with data-intensive research, build trust with participants and their communities, and promote autonomy of potential participants. We recognise that the inclusion of visual or multimedia content to facilitate information transfer is only one component of the informed consent process for data-intensive research. Research ethics committees (RECs) should be mindful of other key considerations and challenges of informed consent for data-intensive research in sub-Saharan Africa (SSA), and to explore whether these alternative forms of consent are ethical and effective in multilingual contexts.

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.

The sanctity of the doctor-patient relationship is deeply embedded in tradition – the Hippocratic oath, medical ethics, professional codes of conduct, and legislation – all of which are being disrupted by big data and ‘artificial’ intelligence (AI). The transition from paper-based records to electronic health records, wearables, mobile health applications and mobile phone data has created new opportunities to scale up data collection. Databases of unimaginable magnitude can be harnessed to develop algorithms for AI and to refine machine learning. Complex neural networks now lie at the core of ubiquitous AI systems in healthcare. A transformed healthcare environment enhanced by innovation, robotics, digital technology, and improved diagnostics and therapeutics is plagued by ethical, legal and social challenges. Global guidelines are emerging to ensure governance in AI, but many low- and middle-income countries have yet to develop context- specific frameworks. Legislation must be developed to frame liability and account for negligence due to robotics in the same way human healthcare providers are held accountable. The digital divide between high- and low-income settings is significant and has the potential to exacerbate health inequities globally.