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

Francis Barchi,Madison T Little

doi:10.1186/s12910-016-0146-9

Abstract

BackgroundEthical and regulatory guidance on the collection and use of human biospecimens (HBS) for research forms an essential component of national health systems in Sub-Saharan Africa (SSA), where rapid advances in genetic- and genomic-based technologies are fueling clinical trials involving HBS and the establishment of large-scale biobanks.MethodsAn extensive multi-level search for publicly available ethics regulatory guidance was conducted for each SSA country. A second review documented active trials listed in the WHO International Clinical Trials Registry Platform as of January 2015 in which HBS collection was specified in the protocol. Findings were combined to determine the extent to which countries that are study sites for HBS-related research are supported by regulatory guidance language on the collection, use, ownership and storage of biospecimens.ResultsOf the 49 SSA countries, 29 had some form of national ethics guidance, yet only 17 provided language relating to HBS-related research, with specific guidance on consent (14), ownership (6), reuse (10), storage (9), and export/import/transfer (13). Ten countries accounted for 84 % of the active clinical trials involving the collection of HBS in SSA. All except one of these countries were found to have some national guidance in the form of regulations, codes of ethics, and/or standard operating procedures; however, only seven of the ten offered any language specific to HBS.ConclusionsDespite the fact that the bulk of registered clinical trials in SSA involving HBS, as well as existing and proposed sites for biorepositories under the H3Africa Initiative, are currently situated in countries with the most complete ethics and regulatory guidance, variability in the regulations themselves may create challenges for planned and future pan-African collaborations and may require legislative action at the national level to revise. Countries in SSA that still lack regulatory guidance on HBS will require extensive health system strengthening in ethics governance before they can be full participants in the modern research enterprise.

Highlights

Ethical and regulatory guidance on the collection and use of human biospecimens (HBS) for research forms an essential component of national health systems in Sub-Saharan Africa (SSA), where rapid advances in genetic- and genomic-based technologies are fueling clinical trials involving HBS and the establishment of large-scale biobanks
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
This study examined the availability of national ethics and regulatory guidance on biomedical research in SubSaharan African countries and identified the extent to which national regulatory systems provided ethics guidance on specific aspects of HBS collection and use to inform research design and ethics review

Summary

Introduction

Ethical and regulatory guidance on the collection and use of human biospecimens (HBS) for research forms an essential component of national health systems in Sub-Saharan Africa (SSA), where rapid advances in genetic- and genomic-based technologies are fueling clinical trials involving HBS and the establishment of large-scale biobanks. Biorepositories already exist in three SSA countries—The Gambia, South Africa, Zimbabwe [1,2,3]. Major expansion in this domain is occurring in Sub-Saharan Africa, largely. 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.

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