Developing a Principles-Based Framework to Link the Governance of Genomics Research and Biobanking in Africa to Global Health Justice

Doctoral Thesis


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Background Genomics research has introduced significant transformations in the way health research is traditionally structured. Firstly, genomics research often requires long-term storage of biological samples for future unspecified uses. Secondly, the stored samples may be shared with researchers across the globe for the purposes of research. Thirdly, genomics researchers are increasingly required to make their research data publicly available for use by other researchers and institutions from around the world. Whilst data and sample sharing offers significant benefits for global health research, in Africa, it is taking place amidst a background of:structural inequities in health and health research between Africa and High Income Countries (HICs). There are also concerns around the exploitation of African researchers and study populations, mainly hinged on historical experiences in global health research, what has been termed scientific imperialism or “extractive” research. It is therefore not surprising that the rise in genomics research and biobanking studies in Africa has been accompanied by strong calls to address the ethical legal and social issues (ELSIs) raised by genomics research and biobanking in Africa. Some of these ELSIs focus on individual-level issues (micro-justice), others go beyond that to include broader societal ELSIs (macro-level justice) such as: secondary access to samples and data, benefit sharing, exploitation of African researchers and populations, intellectual property and the ownership of samples and data. One way of addressing these macro-level justice-related ELSIs is through governance. Aim and Objectives The aim of this study isto develop a governance framework that could be used to address macrolevel-justice-ELSIs in genomics research and biobanking in Africa. To achieve this aim, I put forth the following specific objectives: 1. To identify principles, values and norms that could promote justice and fairness in genomics research and biobanking in Africa; 2. To develop a principles-based governance framework for genomics research and biobanking in Africa that links its policies to the promotion of justice; 3. To investigate how the governance of current day genomics research and biobanking projects in Africa have considered concerns of justice and fairness; 4. To explore the views of key stakeholders on fair and just governance mechanisms for genomics research and biobanking in Africa. Methodology To develop the governance framework, I used the normative practice-oriented bioethics (NPOB) approach. This required adopting a number of methodologies, both conceptual and empirical. The conceptual work used the convergence approach and consisted of a theoretical analysis of two theories of global health justice, namely: shared health governance (by Jennifer Ruger) and global governance for health (by Larry Gostin); as well as the African philosophy of Ubuntu. Through the conceptual and normative analysis, I identified a number of principles that could inform the governance of genomicsresearch and biobanking in Africa. These principles were used to propose a governance framework that could address macro-level justice ELSIs in genomics research and biobanking programs in Africa. Following the development of the governance framework, we used empirical bioethics research methods to probe whether and how the framework’s principles could be practically promoted in genomics research and biobanking consortia in Africa and to revise the framework where necessary. To do this, I used the reflective equilibrium approach. This included checking the proposed framework’s principles and recommendations against current governance practices of a genomics research consortia in Africa as well as well as prompting various stakeholders to think of how these principles could be applied in practice, or how the have been applied within genomics research consortia in Africa. Using the Human Heredity and Health in Africa (H3Africa) Consortium as a case study, as well as two qualitative research methods: content analysis of H3Africa governance documents and one-on-one in-depth interviews (n=15), I checked the framework’s principles against the empirical data and revised as, and when necessary (reflective equilibrium). Results The conceptual analysis led to the identification of the following nine principles: solidarity, reciprocity, furthering the ideals of health justice (FIHJ), shared sovereignty, shared resources, transparency, shared responsibility; mutual trust and mutual collective accountability. These principles were used to develop a principles-based governance framework for genomicsresearch and biobanking. Because I wanted develop a governance framework that is practically implementable, I made recommendations on how each principle could be actualised genomics research in Africa. Analysis of the empirical data showed that the majority of the framework’s principles and or recommendations were being promoted or prioritized by H3Africa ELSI governance. Equally, many H3Africa the principles and recommendations were considered by various H3Africa stakeholders to be critical in promoting justice and fairness in genomics research and biobanking projects in Africa. This suggests that our framework’s requirements are not just theoretical but could be implemented in practice and that there was some buy-in by stakeholders involved in genomics projects in Africa. A key area of deviation between the principles-based framework and the empirical data was the involvement of study populations in decision making (e.g. decision making on sample and data use; research priority setting etc.) The empirical data however showed that there was little involvement of study populations in decision-making within the H3Africa consortium, our case study. Whilst the different stakeholders acknowledged the importance of including study populations in governance processes, there were parallel concerns about its practicability. Despite these, the conceptual analysis and interview data confirms that there is need to first and foremost consider study populations as a key stakeholder group that should be involved in decision making, including decisions on secondary use of samples and data and in the development of biobank policies that will directly affect them. A new principle emerged from the empirical data. This was the principle of mutual respect. Following the reflective equilibrium approach, the framework was revised to include mutual respect as a core guiding principle. Conclusion Using the normative practice oriented bioethics approach, I have developed a novel, principlesbased governance framework for genomics research and biobanking in Africa. This framework, which was derived following a conceptual analysis of the governance theories, as well as the reflective equilibrium approach, seeks to address justice-related-(macro-level)- ELSI sin genomics research and biobanking in Africa. It and is grounded in theories of global health justice and the African moral theory of Ubuntu. Although the framework was developed to support the governance of genomics research and biobanking in Africa, its principles are likely to be applicable to other forms of global health research.