South Africa visit

LETS-South Africa Visit Report 

Marceline Djuidje Ngounoue Epse Ndzie, January 2025 

LETS Report of the REDSSA and ARESA seminars in Cape Town, South Africa  

From 12-14 November 2024, significant research ethics seminars were held at the Cape Town Marriott Hotel Crystal Towers in Century City, South Africa. These seminars were co-organized by the Centre for Medical Ethics and Law at Stellenbosch University and the Center for Bioethics at the University of North Carolina, United States. REDSSA stands for Research for Ethical Data Science in Sub-Saharan Africa and ARESA stands for Advancing Research Ethics Training in Southern Africa.  The events attracted over 80 stakeholders in research ethics and regulation from sub-Saharan Africa, along with seasonal clinical research scientists from around the globe. Participants were from Botswana, Cameroon, Ethiopia, France, Ghana, The Gambia, Kenya, Malawi, Eswatini, Namibia, South Africa, Switzerland, Uganda, Zambia, and the United States of America. The insights gained from these events are summarized in the sections below.  Additionally, the REDSSA African Consortium of Bioethicists held its meeting in hybrid format during this period. 

1. Insights from the pre-workshop seminar titled "Enhancing Youth Health: Leveraging AI Opportunities in Research"  

After a welcome address by Professor Keymanthri Moodley, the PI for both REDSSA and ARESA, there were two key presentations prior to group work on case study discussions. The talks were on enabling digital health promotion for youth in LMICs/unlocking digital health promotion to foster youth health, with ethics and policy considerations in three sub-Saharan countries (Kenya, Ghana and South Africa) and it was delivered by Dr Agatha Ferretti from ETH Zurich. This presentation emphasized the need to engage the youth when developing AI tools that can improve their health in order to improve utility. Also, this talk highlighted the importance of involving youth in low- and middle-income countries (LMICs) when developing youth health policies. This approach can address challenges related to low utilisation, privacy, and confidentiality. Additionally, digital health technologies for health promotion should be tailored to meet the needs of young people. When implementing these applications, providing clear scientific statements, comprehensive messages, and a well-defined scope for the tools is essential. 

The presentation thus exposed the challenges and gaps such as transparency, explainability, sustainability and community engagement, and emphasized the need for reforming processes/existing frameworks to enable ethically aligned digital health promotion.  This presentation was followed by an informative talk given by Professor Dr. Andreas Reis, head of ethics and governance at the WHO Division of Health Ethics and Governance. He engaged participants on the topic of Ethics and Governance of AI in health. He mentioned that WHO is aware there are cases of large multi-modal models (LMMs) use in healthcare, particularly in areas such as diagnosis and clinical care, patient-guided usage, clerical and administrative tasks, scientific research, and drug development.  From this presentation, attendees learned various guidance tools that have been developed. There are more guidance that are yet to be finalised, including the one that will support RECs when reviewing AI protocols. The discussions highlighted three categories of risks associated with the use of generative AI: use case risks (including errors and hallucinations), health system risks (related to accessibility and affordability), and societal risks (about water and carbon footprints), the issue of data ownership.  

Professor Reis outlined consensus principles for the ethical use of AI, which includes: 

1. Protect autonomy 

2. Promote human well-being, safety, and the public interest 

3. Ensure transparency, explainability, and intelligibility 

4. Foster responsibility and accountability 

5. Ensure inclusiveness and equity 

6. Promote AI that is responsive and sustainable 

As the use of AI for research and development expands, the key messages were that AI can play a vital role in addressing unmet public health needs and improving access, but it is important to recognize the associated risks. This recognition calls for careful attention and the development of new governance models.  

The day concluded with two important meetings: the REDSSA African Consortium of Bioethicists and the REDSSA Advisory Committee. During these meetings, case reports were presented by Dr. Tiwonge Mtande and Dr Limbanazo Matandika from Malawi, as well as Prof. Marelli Claassens from Namibia. The first case involved the ethical review of a research protocol related to a digital app. The second case discussed various diagnostic tools, including GenExpert, which is used for detecting tuberculosis and multidrug resistance. Summary of these case reports and lessons learned included the need for capacity building among REC members to understand the novel approaches for doing AI research.   

2. The 4th annual REDSSA seminar on "Generative AI in Research and the Impact of AI on Research Ethics Committees"  

1. The 4th annual REDSSA seminar focused on Generative AI in Research and its Impact on Research Ethics Committees (RECs). Participants gained insights from various topics presented by seasoned scientists and stakeholders in research ethics and regulation, followed by panel discussions.  

1. The main themes included: the opportunities and risks of applying generative AI in clinical research; pride and research integrity in the age of AI; the implications of generative AI on human cognition; ownership issues regarding generative AI and intellectual property in health research; a review of the current landscape of AI ethics tools; and legal considerations related to the use of generative AI in health research. Additionally, a draft guidance from the World Health Organization (WHO) on RECs and AI-based research was presented. 

2. The discussions highlighted the perspectives of RECs and AI from Southern Africa, emphasizing the need to uphold research ethics principles and the importance of robust stakeholder engagement. Continuous dialogue between researchers, RECs, and AI developers is essential to ensure ethical and transparent AI decision-making processes.  

3. Furthermore, it was recommended that African RECs stay informed about recent advances in generative AI and that policymakers and RECs develop AI-specific ethics guidelines and regulatory frameworks, using UNESCO and WHO guidance documents as a reference. Lastly, African REC members should enhance their expertise in reviewing AI-driven research projects. 

As we advance in AI-driven research, it is crucial to emphasize the importance of upholding the values associated with responsible research conduct. These values include: 

- Honesty in all aspects of research 

- Professional courtesy and fairness in collaboration 

- Good stewardship of research on behalf of others 

- Transparency in conducting research and disseminating findings 

- Fair practices from the conception to the implementation of research  

- Shared accountability in the conduct of research 

- Recognition of Indigenous knowledge and the pursuit of epistemic justice 

By adhering to these principles, we can ensure that research efforts are ethical and equitable. 

3. The 12th annual ARESA seminar on "Navigating Ethical Frontiers: The Role of Data Literacy and Neuroethics."  

The 12th annual ARESA seminar focused on "Navigating Ethical Frontiers: The Role of Data Literacy and Neuroethics."  

The seminar featured state-of-the-art research results, both qualitative and quantitative. Presentations included a health data journey from a dialysis unit to a renal registry, with an introduction to a project in South Africa. The impact of an educational video on data literacy was discussed, along with participants' perspectives on this video, which was developed in three languages: English, Afrikaans, and IsiXhosa.  

Additional topics discussed included neuroethics, which examines the ethical considerations surrounding neuroscience and neurotechnology, as well as the legal and regulatory implications. Presentations and clinical trial results conducted in Western nations on brain implants raised serious questions about brain-computer interfaces (BCIs). When considering the transfer of such research and practices to the Sub-Saharan African context, the key issues are not scientific expertise within the region, but rather the regulations guiding policy development and the readiness of stakeholders. This brings up questions regarding the regulatory implications of artificial intelligence in brain-computer interface technology. Consequently, clinical trials involving brain implants are unlikely to occur in Africa soon, even though the technology is advancing. Therefore, preparation is essential; regulators need training on policy issues, AI systems, software operator responsibilities, and related topics. 

In another session, the ethical framework for regulating neuroscience and neurotechnology was discussed. Partners from organisations such as the UN, UNICEF, WHO, UEF, and WEF are involved in co-creating solutions. It is essential to consider contextually and culturally relevant factors in Africa, given its cultural diversity and the ethical challenges that arise (such as bias, misuse of information, contextual relevance, and cultural relevance), along with other pressing needs and priorities. Strategies like animations can be useful in this regard. There is also a need for culturally informed and trained experts to develop Africa-specific guidelines on these issues. 

Additionally, neuroethical concerns related to the therapeutic use of psychedelics for psychiatric disorders were addressed. Psychedelics are a class of compounds that can profoundly alter, expand, or intensify one’s state of conscious awareness or sensory perceptions, often referred to as "mind manifesting." The interest in psychedelics for mental health arises from a crisis in unmet treatment needs, treatment failures, and a shortage of effective therapies. Therefore, their use should be approached with caution. Ethical guidelines are necessary to improve understanding, ensure community consent, and facilitate proxy consent from family members. 

During the seminars, participants had the opportunity to view PhD posters and engage in networking activities.  

The final seminar concluded with a vote of thanks and the recognition of outstanding bioethicist fellows, specifically PhD holders as project's deliverables at the Division of Medical Ethics and Law at Stellenbosch University, in partnership with the Center for Bioethics at the University of North Carolina at Chapel Hill, USA. So far, a total of five PhD degrees in Clinical and Research Ethics have been awarded—two in South Africa, two in Malawi, and one in Uganda. New PhDs are expected to be accomplished soon in Zambia and South Africa as part of this project. 

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During these events, LETS's representative reached out to scientists and successfully established contact with 12 countries (Botswana, Ethiopia, France, Ghana, Kenya, The Gambia, Zambia, Namibia, South Africa, Switzerland, Uganda, and the United States of America). Over the course of two days, a total of six recorded interviews were conducted. This included three key informant interviews for the STRATEGIC T2.1 project in Kenya, Zambia, and Malawi, as well as three use case analysis interviews for the T2.4, based in Kenya and South Africa. The recordings from these interviews are currently being transcribed for in-depth analysis.