Regulation of genomic and biobanking research in Africa: a content analysis of ethics guidelines, policies and procedures from 22 African countries

Background: The 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. Methods: In 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. Results: Surprisingly 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. Conclusions: There 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

'Relief of oppression': An organizing principle for researchers' obligations to participants in observational studies in the developing world

<p>Abstract</p> <p>Background</p> <p>A central question in the debate about exploitation in international research is whether investigators and sponsors from high-income countries (HIC) have obligations to address background conditions of injustice in the communities in which they conduct their research, beyond the healthcare and other research-related needs of participants, to aspects of their basic life circumstances.</p> <p>Discussion</p> <p>In this paper, we describe <b>t</b>he Majengo sexually transmitted disease (STD) Cohort study, a long-term prospective, observational cohort of sex workers in Nairobi, Kenya. Despite important scientific contributions and a wide range of benefits to the women of the cohort, most of the women have remained in the sex trade during their long-standing participation in the cohort, prompting allegations of exploitation. The Majengo STD cohort case extends the debate about justice in international research ethics beyond clinical trials into long-term observational research. We sketch the basic features of a new approach to understanding and operationalizing obligations of observational researchers, which we call 'relief of oppression'. 'Relief of oppression' is an organizing principle, analogous to the principle of harm reduction that is now widely applied in public health practice. Relief of oppression aims to help observational researchers working in conditions of injustice and deprivation to clarify their ethical obligations to participants. It aims to bridge the gap between a narrow, transaction-oriented account of avoiding exploitation and a broad account emphasizing obligations of reparation for historic injustices. We propose that relief of oppression might focus researchers' consideration of benefits on those that have some relevance to background conditions of injustice, and so elevate the priority of these benefits, in relation to others that might be considered and negotiated with participants, according to the degree to which the participating communities are constrained in their realization of fundamental freedoms.</p> <p>Summary</p> <p>The over-arching aim of relief of oppression is that, within the range of benefits negotiated over time with the local communities and organizations, an increasing proportion reflects a shared interest in improving participants' fundamental freedoms. We describe how harm reduction serves as a useful analogy for how we envision relief of oppression functioning in international research.</p

Ethical issues in human genomics research in developing countries

<p>Abstract</p> <p>Background</p> <p>Genome-wide association studies (GWAS) provide a powerful means of identifying genetic variants that play a role in common diseases. Such studies present important ethical challenges. An increasing number of GWAS is taking place in lower income countries and there is a pressing need to identify the particular ethical challenges arising in such contexts. In this paper, we draw upon the experiences of the MalariaGEN Consortium to identify specific ethical issues raised by such research in Africa, Asia and Oceania.</p> <p>Discussion</p> <p>We explore ethical issues in three key areas: protecting the interests of research participants, regulation of international collaborative genomics research and protecting the interests of scientists in low income countries. With regard to participants, important challenges are raised about community consultation and consent. Genomics research raises ethical and governance issues about sample export and ownership, about the use of archived samples and about the complexity of reviewing such large international projects. In the context of protecting the interests of researchers in low income countries, we discuss aspects of data sharing and capacity building that need to be considered for sustainable and mutually beneficial collaborations.</p> <p>Summary</p> <p>Many ethical issues are raised when genomics research is conducted on populations that are characterised by lower average income and literacy levels, such as the populations included in MalariaGEN. It is important that such issues are appropriately addressed in such research. Our experience suggests that the ethical issues in genomics research can best be identified, analysed and addressed where ethics is embedded in the design and implementation of such research projects.</p

Donating Human Samples: Who Benefits? Cases from Iceland, Kenya and Indonesia

Benefit sharing involving human genetic resources is an unresolved topic. Some argue that participation in scientific research should always be altruistically motivated, whcih is how access to human genetic resources has historically been governed in affluent nations. However, uncritically transferring the altruism model to developing countries leads to the emergence of serious exploitation issues. This chapter illustrates the potential for exploitation and other associated ethical concerns through a discussion of three cases: The Icelandic deCODE biobank for genetic research; the sex workers from Nairobi, Kenya, whose samples are used for ongoing HIV/AIDS research; and the Indonesian government's decision to withold virus samples from the World Health Organization in order to achieve fairer benefit sharing. Public attention is captured more easily by global pandemics, but the case of the Nairobi sex workers illustrates that the exploitation issues raised on the international stage by the Indonesian government are not limited to virus sharing. A framework for equitable access to human genetic resources is urgently needed, but in order to ensure justice, this needs to be accompanied by sustained attention to benefit sharing

Benefit Sharing

Research cannot be done by researchers alone. In most cases, additional resources are required, including human research participants, access to biodiversity for biological and genetic resources, or traditional knowledge. Benefit sharing has been part of global conventions and international ethics guidelines for over 25 years, predicated on the understanding that those who contribute to the research process and its outcomes should share in the benefits as a matter of fairness. This chapter explores the different understandings of benefit sharing in a historical context, from the “Grand Bargain” of the Convention on Biological Diversity in 1992 to the Global Code of Conduct for Research in Resource-Poor Settings in 2018, and examines the contemporary potential for the UN Sustainable Development Goals (Agenda 2030) to facilitate benefit sharing. The discussion provides guidance to researchers, through examples and short case studies, on how to discharge the obligations of benefit sharing effectively and fairly, in pursuit of research integrity

Fair for Women? A Gender Analysis of Benefit Sharing

If benefit sharing is about justice, then it needs to be fair for both sexes. This chapter provides a gender analysis of benefit sharing. Five cases are presented, from Kenya (Nairobi sex workers), Nigeria (NIPRISAN), southern Africa (San/Hoodia), India (Kani people), and Iceland (deCODE biobank), to show the ways in which women are politically marginalised, and the implications of this for genuine fairness in benefit sharing. In the light of international commitments to women's rights, international guidelines on benefit sharing are examined for the extent to which they protect such rights. Seeing how gender-based power imbalances on the ground can work against the implementation of guidelines and policies demonstrates the importance of strategies, processes and mechanisms that are sensitive to power dynamics in local contexts. The chapter concludes that all guidelines and policies for benefit sharing should explicitly require women's meaningful participation in all phases of decision-making, and should include examples of the kinds of mechanisms that will enable women to have an effective voice