Background The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium. Methods A qualitative method for text analysis was used to analyse consent documents used in the collection of samples and data in H3Africa projects. Thematic domains included type of consent model, explanations of genetics/genomics, data sharing and feedback of (...) test results. Results Informed consent documents for 13 of the 19 H3Africa projects were analysed. Seven projects used broad consent, five projects used tiered consent and one used specific consent. Genetics was mostly explained in terms of inherited characteristics, heredity and health, genes and disease causation, or disease susceptibility. Only one project made provisions for the feedback of individual genetic results. Conclusion H3Africa research makes use of three consent models—specific, tiered and broad consent. We outlined different strategies used by H3Africa investigators to explain concepts in genomics to potential research participants. To further ensure that the decision to participate in genomic research is informed and meaningful, we recommend that innovative approaches to the informed consent process be developed, preferably in consultation with research participants, research ethics committees and researchers in Africa. (shrink)

Ethical review systems need to build on their experiences of COVID-19 research to enhance their preparedness for future pandemics. Recommendations from representatives from over twenty countries include: improving relationships across the research ecosystem; demonstrating willingness to reform and adapt systems and processes; and making the case robustly for better resourcing.

BackgroundNational Ethics Committees (NECs) offer important oversight and guidance functions and facilitate public debate on bioethical issues. In an increasingly globalized world where technological advances, multi-national research collaborations, and pandemics are creating ethical dilemmas that transcend national borders, coordination and the joining of efforts among NECs are key. The purpose of this study is to take stock of the current NEC landscape, their varying roles and missions, and the range of bioethical topics on which they deliberated since their inception.MethodsData on (...) the availability, functions, and ethical deliberations (publications) of NECs globally were gathered through a systematic search of NEC websites and through contacts known to the authors. The search was conducted in English, French, and Spanish. The data abstraction was done in Excel and included the NEC’s country, region, functions, and deliberations on bioethical issues. Deliberation topics were classified into thematic categories through an iterative process of regrouping to arrive at the main set of themes.Results124 NECs in 100 countries were identified. 44% of the NECs are in Europe and 47% are in high-income countries. Out of the 1108 retrieved publications, 40% were on bioethics in the context of research, followed by the clinic (28%) and public health issues (22%). The top five topics of these publications were: research ethics (124; 9%), genetics and genomics (62; 6%), organ transplantation (58; 5%), assisted reproductive technology (49; 4%), and end of life (36; 3%).ConclusionOur study makes an important contribution to understanding the current interests and functions of NECs and the range of their bioethics deliberations. By making the data publicly available through this publication, it allows users to conduct tailored analyses and queries based on their interests, and to seek and strengthen collaboration and exchange. It also makes the case for the fruitfulness of developing and maintaining a global repository of current and new deliberations to more effectively advance this field for the greater good of humanity, research, and public health. (shrink)

In the past decade, there has been an increase in genomic research and biobanking activities in Africa. Research initiatives such as the Human Heredity and Health in Africa Consortium are contributing to the development of scientific capacity and infrastructure to support these studies on the continent. Despite this growth, genomic research and biobanking have raised important ethical challenges for key research stakeholders, including members of research ethics committees. One of these is the limited ethical and regulatory frameworks to guide the (...) review and conduct of genomic studies, particularly in Africa. This paper is a reflection on a series of consultative activities with research ethics committees in Africa which informed the development of an ethics and governance framework for best practices in genomic research and biobanking in Africa. The paper highlights the engagement process and the lessoned learned. (shrink)

The rise of genomic studies in Africa – not least due to projects funded under H3Africa – is associated with the development of a small number of biorepositories across Africa. For the ultimate success of these biorepositories, the creation of cell lines including those from selected H3Africa samples would be beneficial. In this paper, we map ethical challenges in the creation of cell lines.

Background The ethical governance of Artificial Intelligence (AI) in health care and public health continues to be an urgent issue for attention in policy, research, and practice. In this paper we report on central themes related to challenges and strategies for promoting ethics in research involving AI in global health, arising from the Global Forum on Bioethics in Research (GFBR), held in Cape Town, South Africa in November 2022. Methods The GFBR is an annual meeting organized by the World Health (...) Organization and supported by the Wellcome Trust, the US National Institutes of Health, the UK Medical Research Council (MRC) and the South African MRC. The forum aims to bring together ethicists, researchers, policymakers, research ethics committee members and other actors to engage with challenges and opportunities specifically related to research ethics. In 2022 the focus of the GFBR was “Ethics of AI in Global Health Research”. The forum consisted of 6 case study presentations, 16 governance presentations, and a series of small group and large group discussions. A total of 87 participants attended the forum from 31 countries around the world, representing disciplines of bioethics, AI, health policy, health professional practice, research funding, and bioinformatics. In this paper, we highlight central insights arising from GFBR 2022. Results We describe the significance of four thematic insights arising from the forum: (1) Appropriateness of building AI, (2) Transferability of AI systems, (3) Accountability for AI decision-making and outcomes, and (4) Individual consent. We then describe eight recommendations for governance leaders to enhance the ethical governance of AI in global health research, addressing issues such as AI impact assessments, environmental values, and fair partnerships. Conclusions The 2022 Global Forum on Bioethics in Research illustrated several innovations in ethical governance of AI for global health research, as well as several areas in need of urgent attention internationally. This summary is intended to inform international and domestic efforts to strengthen research ethics and support the evolution of governance leadership to meet the demands of AI in global health research. (shrink)

The Global Forum on Bioethics in Research (GFBR) served as a global platform for debate on ethical issues in international health research between 1999 and 2008, bringing together research ethics experts, researchers, policy makers and community members from developing and developed countries. In total, nine GFBR meetings were held on six continents. Work is currently underway to revive the GFBR. This paper describes the purpose and history of the GFBR and presents key elements for its reinstatement, future functioning and sustainability. (...) Potential participants and sponsors are encouraged to contribute actively to the future of this unique international research ethics event. (shrink)

Community engagement has been recognised as an important aspect of the ethical conduct of biomedical research, especially when research is focused on ethnically or culturally distinct populations. While this is a generally accepted tenet of biomedical research, it is unclear what components are necessary for effective community engagement, particularly in the context of genomic research in Africa.