National ethics guidance in Sub Saharan Africa on the collection and use of human biological specimens: A systematic review

Ethical and regulatory guidance on the collection and use of human biospecimens (HBS) is an essential component of national health systems in Sub-Saharan Africa (SSA) where rapid advances in genetic- and genomic-based technologies are fueling the establishment of large-scale biobanks. Methods: In 2014, two systematic reviews were conducted to identify national guidance documents in SSA and to assess the volume of clinical research involving HBS in each country. Results: Of the 48 countries in SSA, 26 had some form of national ethics guidance, yet only 15 provided ethics language specific to HBS-related research. Ten countries accounted for 84% of the active clinical trials involving the collection of HBS in SSA.  All except one of these were found to have some national ethics guidance in the form of regulations, codes of ethics, and/or standard operating procedures; however, only seven countries offered language specific to HBS and of these most guidance was limited in scope.  Of the remaining 38 countries, fewer than 20% had HBS-specific language and, of those 7, less than 30% had any language related to consent, ownership, reuse, or  export. Conclusions: Despite substantial capacity-building efforts, many countries still lack ethical and regulatory guidance on the collection and use of HBS. Although those African countries most in demand currently as HBS-related clinical research sites are among those offering the most guidance, extensive health system strengthening will be needed to ensure that regulatory language is available to guide the ethical extension of HBS-related research into other countries in the region.