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Genomic research and the biobanking capacity it requires are experiencing considerable growth on the continent of Africa. However genomic research and biobanking raise a range of legal, ethical, social, and cultural issues, including concerns about broad consent, confidentiality, community stigmatization, discrimination, indefinite storage, and long-term use. There is a need to establish governance frameworks that address these issues, and many international health research ethics and biobanking guidelines now recommend that the best way to do so is by involving potential research participants and key community stakeholders in the research development and the process of acquiring samples and data through active community engagement (CE). This article describes the experience and challenges in developing an educational tool as part of a CE initiative in South Africa and the commentaries reflect on how this process may be improved going forward.

Human Heredity and Health in Africa (H3Africa) research seeks to promote fair collaboration between scientists in Africa and those from elsewhere. Here, we outline how concerns over inequality and exploitation led to a policy framework that places a firm focus on African leadership and capacity building as guiding principles for African genomics research., (Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: The rise of genomic studies in Africa - not least due to projects funded under H3Africa - is associated with the development of a small number of biorepositories across Africa. For the ultimate success of these biorepositories, the creation of cell lines including those from selected H3Africa samples would be beneficial. In this paper, we map ethical challenges in the creation of cell lines., Discussion: The first challenge we identified relates to the moral status of cells living in culture. There is no doubt that cells in culture are alive, and the question is how this characteristic is relevant to ethical decision-making. The second challenge relates to the fact that cells in culture are a source of cell products and mitochondrial DNA. In combination with other technologies, cells in culture could also be used to grow human tissue. Whilst on the one hand, this feature increases the potential utility of the sample and promotes science, on the other it also enables further scientific work that may not have been specifically consented to or approved. The third challenge relates to ownership over samples, particularly in cases where cell lines are created by a biobank, and in a different country than where samples were collected. Relevant questions here concern the export of samples, approval of secondary use and the acceptability of commercialisation. A fourth challenge relates to perceptions of blood and bodily integrity, which may be particularly relevant for African research participants from certain cultures or backgrounds. Finally, we discuss challenges around informed consent and ethical review., Summary: In this paper, we sought to map the myriad of ethical challenges that need to be considered prior to making cell line creation a reality in the H3Africa project. Considering the relative novelty of this practice in Africa, such challenges will need to be considered, discussed and potentially be resolved before cell line creation in Africa becomes financially feasible and sustainable. We suggest that discussions need to be undertaken between stakeholders internationally, considering the international character of the H3Africa project. We also map out avenues for empirical research.

H3Africa is developing capacity for health-related genomics research in Africa

Background: Biospecimen shipping and handling challenges in Africa include climates that can potentially jeopardize sample integrity, and infrastructure and regulation limitations that affect courier reliability, access, and costs. There is a lack of investigations reporting on validation of standardized processes for biospecimen exchange among African countries and regions. The Human Heredity and Health in Africa (H3Africa) Initiative funded four African biorepositories (BR) to pilot test operations, and assess effectiveness of trans-African shipment of high-quality DNA, and other biospecimens for genomics research. Pilot studies tested the following: workflows and forms related to biospecimen exchange, transport logistics, and comparability and confirmation of quality control (QC) methods. Methods: Ethical and legal requirements for biospecimen, and data transfer were acquired before shipment. Biospecimens were collected and subjected to QC by the BR of origin before shipment, and by the recipient BR on arrival. Minimal QC requirements included concentration and purity for DNA. Paired Student's t-tests were used to determine significant differences in DNA concentrations, DNA purity, and urine pH pre- and postshipment. Results: The turnaround time for import/export permits was 21-90 days and material transfer agreements 1-10 months. There were nine shipments. Shipping duration averaged 5 days. Shipments sent at uncontrolled ambient temperature fluctuated between 5.6°C and 32.7°C. Seventy-seven percent of source DNA had purity ratios within the acceptable range before shipment. Eighty-nine percent of the DNA results did not differ significantly before and after shipment. Ninety-five percent of DNA extracted from shipped whole blood had acceptable purity. Conclusion: African BRs can collect, process, store, and ship biospecimens of good quality. This study shows it is possible to ship biospecimens between different regions of Africa in a reasonable time frame, without compromise to the cold chain and biospecimen integrity. It is also possible to harmonize ethical documents, guidelines, and processes among African BRs to facilitate collaboration. [ABSTRACT FROM AUTHOR]