BackgroundThe introduction of genomics and biobanking methodologies to the African research context has also introduced novel ways of doing science, based on values of sharing and reuse of data and samples. This shift raises ethical challenges that need to be considered when research is reviewed by ethics committees, relating for instance to broad consent, the feedback of individual genetic findings, and regulation of secondary sample access and use. Yet existing ethics guidelines and regulations in Africa do not successfully regulate research based on sharing, causing confusion about what is allowed, where and when.MethodsIn order to understand better the ethics regulatory landscape around genomic research and biobanking, we conducted a comprehensive analysis of existing ethics guidelines, policies and other similar sources. We sourced 30 ethics regulatory documents from 22 African countries. We used software that assists with qualitative data analysis to conduct a thematic analysis of these documents.ResultsSurprisingly considering how contentious broad consent is in Africa, we found that most countries allow the use of this consent model, with its use banned in only three of the countries we investigated. In a likely response to fears about exploitation, the export of samples outside of the continent is strictly regulated, sometimes in conjunction with regulations around international collaboration. We also found that whilst an essential and critical component of ensuring ethical best practice in genomics research relates to the governance framework that accompanies sample and data sharing, this was most sparingly covered in the guidelines.ConclusionsThere is a need for ethics guidelines in African countries to be adapted to the changing science policy landscape, which increasingly supports principles of openness, storage, sharing and secondary use. Current guidelines are not pertinent to the ethical challenges that such a new orientation raises, and therefore fail to provide accurate guidance to ethics committees and researchers.

Military metaphors are pervasive in biomedicine, including HIV research. Rooted in the mindset that regards pathogens as enemies to be defeated, terms such as “shock and kill” have become widely accepted idioms within HIV cure research. Such language and symbolism must be critically examined as they may be especially problematic when used to express scientific ideas within emerging health-related fields. In this paper, philosophical analysis and an interdisciplinary literature review utilizing key texts from sociology, anthropology, history, and Chinese and African studies were conducted to investigate the current proliferation of military metaphors. We found the use of these metaphors to be ironic, unfortunate, and unnecessary. To overcome military metaphors we propose to: 1) give them less aggressive meanings, and/or 2) replace them with more peaceful metaphors. Building on previous authors’ work, we argue for the increased use of “journey” (and related) metaphors as meaningful, cross-culturally appropriate alternatives to military metaphors.

BackgroundBiological sample and data transfer within and out of Africa is steeped in controversy With the H3Africa project now aiming to establish biobanks in Africa, it is essential that there are ethical and legal governance structures in place to oversee the operation of these biobanks. Such governance is essential to ensuring that donors are protected, that cultural perspectives are respected and that researchers have a ready availability of ethically sourced biological samples.MethodsA literature review of all legislation, regulations, guidelines and standard operating procedures on informed consent, confidentiality and the transfer of biological samples amongst countries in Sub-Saharan Africa was conducted. In addition, an examination of the websites of departments of health and national ethics committees was performed. Researchers and research ethics scholars in the field in various African countries were contacted for assistance. A literature review of all studies examining participants views on issues related to biobanking in Africa was carried out and five separate studies were found.ResultsIt was found that biobanking guidelines differ substantially across Sub-Saharan Africa regarding biobanking and often conflicted across borders. This has the potential to negatively impact collaboration. Furthermore, the guidelines in place often do not recognise the ethical difficulties arising from the transfer of biological samples and are unsuitable to regulate biobanks. Additionally, there is insufficient research into the views of research participants and stakeholders on the use of biological /samples.ConclusionCollaboration is necessary to ensure the success of biobanking projects in Africa. To achieve this, there should be some harmonization of guidelines across Africa which would aid in transferring biological samples across borders. These guidelines should reflect the unique ethical issues arising out of the storage and secondary uses of biological samples. Finally, further research into the views of research participants is necessary. Such studies should aid in the drafting of any new harmonization guidelines.

BackgroundGenomic 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.MethodsTo 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.ResultsSeveral 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.ConclusionCE 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.

The General Data Protection Regulation (GDPR) came into force in May 2018. The aspiration of providing for a high level of protection to individuals’ personal data risked placing considerable constraints on scientific research, which was contrary to various research traditions across the EU. Therefore, along with the set of carefully outlined data subjects’ rights, the GDPR provides for a two-level framework to enable derogations from these rights when scientific research is concerned. First, by directly invoking provisions of the GDPR on a condition that safeguards that must include ‘technical and organisational measures’ are in place and second, through the Member State law. Although these derogations are allowed in the name of scientific research, they can simultaneously be challenging in light of the ethical requirements and well-established standards in biobanking that have been set forth in various research-related soft legal tools, international treaties and other legal instruments. In this article, we review such soft legal tools, international treaties and other legal instruments that regulate the use of health research data. We report on the results of this review, and analyse the rights contained within the GDPR and Article 89 of the GDPR vis-à-vis these instruments. These instruments were also reviewed to provide guidance on possible safeguards that should be followed when implementing any derogations. To conclude, we will offer some commentary on limits of the derogations under the GDPR and appropriate safeguards to ensure compliance with standard ethical requirements.

The high burden of infectious diseases and the growing problem of noncommunicable and metabolic disease syndromes in South Africa (SA) forces a more focused research approach to facilitate cutting-edge scientific growth and public health development. Increased SA research on these diseases and syndromes and the collection of associated biospecimens has ensured a plethora of biobanks created by individuals, albeit without the foresight of prospective and collective use by other local and international researchers. As the need for access to high-quality specimens in statistically relevant numbers has increased, so has the necessity for the development of national human biobanks in SA and across the Continent. The prospects of achieving sustainable centralized biobanks are still an emerging and evolving concept, primarily and recently driven by the launch of the H3Africa consortium, which includes the development of harmonized and standardized biobanking operating procedures. This process is hindered by a myriad of complex societal considerations and ethico-legal challenges. Efforts to consolidate and standardize biological sample collections are further compromised by the lack of full appreciation by national stakeholders of the biological value inherent in these collections, and the availability of high quality human samples with well-annotated data for future scientific research and development. Inadequate or nonexistent legislative structures that specifically regulate the storage, use, dispersal, and disposal of human biological samples are common phenomena and pose further challenges. Furthermore, concerns relating to consent for unspecified future uses, as well as access to information and data protection, are all new paradigms that require further consideration and public engagement. This article reviews important fundamental issues such as governance, ethics, infrastructure, and bioinformatics that are important foundational prerequisites for the establishment and evolution of successful human biobanking in South Africa.

Genomic research and biobanking are expanding globally, with a promise to fast-track the research needed to improve approaches to disease treatment and prevention through scientific collaborations such as the Human Heredity and Health in Africa (H3Africa) initiative. Integral to this type of research is the availability of samples and data for research. The need for broad access brings along a host of ethical concerns, including those related to privacy and confidentiality, as well as fairness and equity in access and capacity to utilise these samples between scientists from the high income and low income countries. Addressing these concerns while promoting genomic research, especially in Africa, requires the implementation of a sound governance framework. In this paper, we describe the contents of a Framework for Best Practice for Genomics Research and biobanking in Africa that was developed, under the auspices of the H3Africa initiative. This framework is broad enough to be used and adapted by African countries to facilitate the development of country-specific guidelines and to help improve the conduct and governance of genomics research.

In June 2014, the H3Africa Working Group on Ethics organised a workshop with members of over 40 research ethics committees from across Africa to discuss the ethical challenges raised in H3Africa research, and to receive input on the proposed H3Africa governance framework. Prominent amongst a myriad of ethical issues raised by meeting participants were concerns over consent for future use of samples and data, the role of community engagement in large international collaborative projects, and particular features of the governance of sample sharing. This report describes these concerns in detail and will be informative to researchers wishing to conduct genomic research on diseases pertinent to the African research context.