Ethical issues in the collection, export, storage and uses of human biological samples in Africa: an analysis of stakeholders' perspectives

The collection, storage, export and use of human biological samples are important research practices in international collaborative research. However, the limitations of current ethical and regulatory frameworks to govern these research practices have resulted in inconsistencies in practice and a number of ethical concerns for researchers, research institutions and research ethics committees (RECs).The aim of this thesis was to contribute to an empirically-informed understanding of the ethical issues arising in the export, storage and future uses of human biological samples from sub-Saharan Africa (SSA). The thesis is based on an empirical bioethics project to examine stakeholders’ perspectives of and responses to the ethical issues arising in these research practices. I employed a qualitative strategy of inquiry involving document review, observations, semi-structured interviews and focus group discussions with key stakeholders in Nairobi and Kilifi in Kenya and Navrongo and Accra in Ghana.The project suggests that the ethical issues arising from the use of human biological samples depends on the nature of interactions between key stakeholders in biomedical research. Despite the compelling reasons for sample export, storage and use, and the existence of structures governing these research practices, the stakeholders I interviewed expressed several practical ethical concerns. These relate to consent, cultural sensitivities around blood, local control of samples, power-relations, capacity building and trust-relationships.Drawing on these findings and existing literature, I argue that host research institutions bear the ultimate responsibility for the ethical conduct of research and should act as responsible stewards of research samples. I argue that it is important to refocus attention on important values in international research ethics such as trustworthiness to address the issues arising in practice. Recognising the limitations of current governance mechanisms and the uncertainties surrounding future uses of samples, I propose an entrustment framework to strengthen relationships between communities and host research institutions on one hand and between collaborating research institutions for research involving human biological samples in Africa. I also propose a set of ‘points-to-consider’ for research institutions, ethics committees and funding agencies.