Challenges in biobank governance in Sub-Saharan Africa

Abstract

BackgroundBiological sample and data transfer within and out of Africa is steeped in controversy With the H3Africa project now aiming to establish biobanks in Africa, it is essential that there are ethical and legal governance structures in place to oversee the operation of these biobanks. Such governance is essential to ensuring that donors are protected, that cultural perspectives are respected and that researchers have a ready availability of ethically sourced biological samples.MethodsA literature review of all legislation, regulations, guidelines and standard operating procedures on informed consent, confidentiality and the transfer of biological samples amongst countries in Sub-Saharan Africa was conducted. In addition, an examination of the websites of departments of health and national ethics committees was performed. Researchers and research ethics scholars in the field in various African countries were contacted for assistance. A literature review of all studies examining participants views on issues related to biobanking in Africa was carried out and five separate studies were found.ResultsIt was found that biobanking guidelines differ substantially across Sub-Saharan Africa regarding biobanking and often conflicted across borders. This has the potential to negatively impact collaboration. Furthermore, the guidelines in place often do not recognise the ethical difficulties arising from the transfer of biological samples and are unsuitable to regulate biobanks. Additionally, there is insufficient research into the views of research participants and stakeholders on the use of biological /samples.ConclusionCollaboration is necessary to ensure the success of biobanking projects in Africa. To achieve this, there should be some harmonization of guidelines across Africa which would aid in transferring biological samples across borders. These guidelines should reflect the unique ethical issues arising out of the storage and secondary uses of biological samples. Finally, further research into the views of research participants is necessary. Such studies should aid in the drafting of any new harmonization guidelines.

H3Africa: a tipping point for a revolution in bioinformatics, genomics and health research in Africa

“…The initiative, referred to as H3Africa, is an acronym that stands for Human Heredity and Health in Africa [1-4]. The projects currently funded under this initiative are demonstrated in Figure 1[1,2].…”

Infrastructure and Facilities for Human Biobanking in Low- and Middle-Income Countries: A Situation Analysis

“…These committees are responsible for reviewing and approving research activities. However, ELSIs specific to biobanking or biobank projects are usually not included in the committees' review processes, and this is an important challenge in biobank governance in LMICs [14]. For example, most centres do not have patient-consent procedures for the systematic storage of postanalysis clinical samples for future research.…”

Clinical Research on Neglected Tropical Diseases: Challenges and Solutions

“…Indeed, clinical research conducted in resource-constrained settings has to come to grips with essential challenges related to community engagement, participants’ vulnerability, upgrade of local clinical and laboratory infrastructures, data sharing, sample storage and shipment abroad, capacity transfer, and benefit sharing. For instance, a recent systematic review has underscored that there is considerable heterogeneity across sub-Saharan Africa regarding biobanking issues, with often conflicting regulations and guidelines in different countries, which are likely to negatively affect international collaborative efforts [33]. Additionally, the harmonization of diagnostic and clinical procedures in multi-country studies is frequently not sufficiently addressed and, particularly in low- and middle-income countries, training and adherence to GCP/GCLP guidelines is particularly challenging [34].…”