Abstract
BackgroundThe Institute of Human Virology Nigeria (IHVN) – Human Heredity and Health in Africa (H3Africa) Biorepository (I-HAB) seeks to provide high-quality biospecimens for research. This depends on the ability of clinical research sites (CRS) – who provide biospecimens – to operate according to well-established industry standards. Yet, standards are often neglected at CRSs located in Africa. Here, I-HAB reports on its four-pronged approach to empower CRSs to prepare high-quality biospecimens for research.ObjectivesI-HAB sought (1) to assess a four-pronged approach to improve biobanking practices and sample quality among CRSs, and (2) to build human capacity.MethodsI-HAB partnered with two H3Africa principal investigators located in Nigeria and Ghana from August 2013 through to May 2017 to debut its four-pronged approach (needs assessment, training and mentorship, pilot, and continuous quality improvement) to empower CRSs to attain high-quality biospecimens.ResultsClose collaborations were instrumental in establishing mutually beneficial and lasting relationships. Improvements during the 12 months of engagement with CRSs involved personnel, procedural, and supply upgrades. In total, 51 staff were trained in over 20 topics. During the pilot, CRSs extracted 50 DNA biospecimens from whole blood and performed quality control. The CRSs shipped extracted DNA to I-HAB and I-HAB that comparatively analysed the DNA. Remediation was achieved via recommendations, training, and mentorship. Preanalytical, analytical and post-analytical processes, standard operating procedures, and workflows were systematically developed.ConclusionPartnerships between I-HAB and H3Africa CRSs enabled research sites to produce high-quality biospecimens through needs assessment, training and mentorship, pilot, and continuous monitoring and improvement.
Highlights
Biobanking is underdeveloped in Africa.[1,2] Obvious obstacles include sparse financial resources, challenging operating environments, underdeveloped infrastructure, inferior logistics, and an unreliable electrical power supply.[2,3,4,5] preanalytical processes occurring at collection sites affect biospecimen quality.[3]
The United States National Institutes of Health (NIH) and the Wellcome Trust founded Human Heredity and Health in Africa (H3Africa) to promote genomic research in Africa through funding of African researchers, and provision of bioinformatics core and biorepositories located in Nigeria, South Africa, and Uganda.[6]
The NIH assigned in Africa (H3Africa) Biorepository (I-HAB) six research projects including Project A – a clinical research sites (CRS) located in Tanzania, Nigeria, and Ghana, with the project’s central laboratory hub in Ghana – and Project B, with a CRS and laboratory hub in Nigeria
Summary
Biobanking is underdeveloped in Africa.[1,2] Obvious obstacles include sparse financial resources, challenging operating environments, underdeveloped infrastructure, inferior logistics, and an unreliable electrical power supply.[2,3,4,5] preanalytical processes occurring at collection sites affect biospecimen quality.[3]. The United States National Institutes of Health (NIH) and the Wellcome Trust founded Human Heredity and Health in Africa (H3Africa) (www.h3Africa.org) to promote genomic research in Africa through funding of African researchers, and provision of bioinformatics core and biorepositories located in Nigeria, South Africa, and Uganda.[6] The NIH required biorepositories to complete a feasibility phase (Phase I) to qualify for the implementation phase (Phase II). The Institute of Human Virology Nigeria (IHVN) – Human Heredity and Health in Africa (H3Africa) Biorepository (I-HAB) seeks to provide high-quality biospecimens for research. This depends on the ability of clinical research sites (CRS) – who provide biospecimens – to operate according to well-established industry standards. I-HAB reports on its four-pronged approach to empower CRSs to prepare high-quality biospecimens for research
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