Exponential growth in the fields of pharmacogenetics and genomics research over the past decade is fueling worldwide interest in the establishment of biorepositories of human biological specimens. Biorepositories already exist in three SSA countries—The Gambia, South Africa, Zimbabwe [1–3]. Major expansion in this domain is occurring in Sub-Saharan Africa, largely driven by the Human Heredity and Health in Africa Initiative (H3Africa), a joint effort of the National Institutes of Health (NIH), the Wellcome Trust, and the African Society for Human Genetics [4]. The ‘hub and spoke’ model adopted by this initiative calls for the development of four pilot regional biobanks – two in South Africa and one each in Nigeria and Uganda – which will serve as multi-country repositories of specimens collected under sponsored research activities taking place throughout the region [5]. The H3Africa Initiative reflects significant efforts by the international community of researchers, funding agencies, and African academic institutions to build a foundation for sophisticated, state-of-the-art genomic research on burdensome diseases in Africa; the ultimate goal of the initiative is to improve the health of the African peoples.
From its inception, the initiative has sought broad consensus on topics relating to ethics and governance A Joint NIH and Wellcome Trust Policy document sets forth high-level principles on ethics, governance, and resource sharing with which research networks and programs funded by the initiative are expected to comply [6]. A standing working group on ethics and regulatory issues comprising ethicists and other members of the scientific community meets periodically to discuss and develop recommendations on a wide range of topics including community engagement strategies, cultural issues, informed consent, participant safety, return of results, intellectual property, material transfer agreements, and other regulatory issues. While such guidance has the potential to serve as a model framework for all countries in Africa to consider as they develop their own national guidelines, the current focus of the initiative is on those entities that it supports. Applied more broadly, the pan-continental approach espoused by H3Africa and similar initiatives may require a level of ethical guidance at the country level explicitly addressing the collection and use of HBS which is currently not to be found in most national ethics regulatory guidance. In many African countries, such systems are in their infancy; policies that address emerging technologies such as whole genome sequencing and association studies are absent [7, 8].
The International Declaration on Human Genetic Data, promulgated by UNESCO in 2003, recognized the importance of national policies to guide the collection, processing, use, and storage of human genetic data, as well as the review by local and institutional ethics committees of protocols involving such data [9]. In Africa specifically, a growing body of literature has focused on the need to have ethical and legal governance structures in place to oversee research involving HBS and the operation of biobanks [10, 11].
If the H3Africa vision of a pan-continental genomic enterprise is to be fully realized, ethics guidelines at the national level must align in ways that support interoperability among African countries. In cases where no guidelines presently exist, investment in institutional capacity-building by such entities as H3Africa and others may be needed to support their development. In cases where national guidelines do exist, some may require the addition of new language specific to research involving HBS; such revisions may require legislative approval. There may be instances where national values simply will not support the transnational transfer of genetic information, broad data sharing within research communities (however relevant to their populations), or the delegation of decision-making on future use to an outside authority. The lack of interoperability among African nations in their ethics guidance as well as differences in interpretation of meaning in instances where international recommendations have been adopted has the potential to slow, even derail, the realization of benefit from new advances and approaches in biomedical research [10, 12].
Although a number of scholars have examined the ethical, legal, and social issues associated with the collection and use of biospecimens in research, there has been far less focus on the existence and nature of regulatory guidance on HBS at the national level in Sub-Saharan Africa [8, 11–17]. Of particular importance is the identification of national ‘gaps’ in ethics guidance, as well as inconsistencies and national differences among those countries where guidance does exist.