H3Africa partnerships to empower clinical research sites to generate high-quality biological samples

Abstract

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 Also, preanalytical processes occurring at collection sites affect biospecimen quality. 3 Past reports documented destitute laboratory systems, and the hope for advancements through international declarations, funding, networking, training, and mentorship. 6,7,8,9 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 NIH also assigned H3Africa research projects to a biorepository and required projects to deposit Background: 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. 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.Objectives: I-HAB sought (1) to assess a four-pronged approach to improve biobanking practices and sample quality among CRSs, and (2) to build human capacity.Methods: I-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.Results: Close 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. Conclusion:Partnerships 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.

Health research mentorship in low- and middle-income countries: a scoping review

“…8,17,18,24,[33][34][35]37,[41][42][43][44]46,48,50,51,53,57,59,61,62,65,66,68,[79][80][81]85 Others were from the Americas (n = 7), 29,49,[69][70][71][72]83 South East Asia (n = 4), 30,64,67,78 Eastern Mediterranean (n = 2), 56,82 and Western Pacific (n = 2) 58,88 regions according to the World Health Organization regional classification. 89 A total of 26 studies and reports were from LMICs 2,5,9,19,20,23,26,28,31,32,36,…”

“…Virtual platforms, emails, and establishment of an alumni network were considered to leverage opportunities for mentoring. 8,16,17,23,26,27,29,31,32,34,39,61,64,65,71,74,75,78,85,86 In addition, the included studies and reports described the following as non-regular and noninstitutionalized approaches to improve research capacity and development of fundable projects for junior researchers: developing mentorship training modules or syllabuses; training workshops on core elements of research, including publication; establishing research clubs with defined shared values; Funding source Mentorship program/s initiated and funded by institutions from HICs (n = 55) 2,5,8,9,16,17,19-24,26-29,31-36,38-41, 45-47,49,51-64,66-68,70,73-77,79,87 Mentorship program initiated and funded by institutions from both LMICs and HICs (n = 7) 18,25,30,44,48,84,88 Mentorship program/s initiated and funded by institutions from LMICs (n = 5) 37,50,65,78,80 Source of funding not reported (n = 10) 42,43,69,71,72,[81][82][83]85,86 Authorship status (first author) Primary authors from LMICs (n = 41) 5,...…”

“…Mentors were researchers or institutions affiliated from HICs while mentees were researchers in LMICs (n = 56) 2,5,8,9,16,[18][19][20][21][22][23][24][25][26][27][28][29]31,32,[34][35][36][38][39][40][41]44,45,[47][48][49][51][52][53][54][55][57][58][59][60][61][62][63][64]66,67,70,[73][74][75][76][77]79,84,87,88 Mentors were from both HICs and LMICs (n = 3) 18,…”

Overview of The Human Heredity and Health in Africa Kidney Disease Research Network (H3A-KDRN)

“…DNA from the H3A-KDRN has been deposited in the Institute of Human Virology of Nigeria Abuja biorepository. 11 In addition, an H3Africa data and biospecimen access committee was set up to ensure responsible access by scientists from out-with the consortium.…”

Framework de processos para a gestão de centros de pesquisa clínica

“…As tarefas relacionadas a este processo vão variar a depender do protocolo -que varia o tipo de amostra e a forma e local de processamento (local ou centralizado) -ou do centro -que pode estar ligado a um hospital, clínicas ou possuir um serviço parceiro. Todos os centros devem ter atenção aos procedimentos de coleta, processamento, armazenamento, envio e controle de qualidade, mas centros que possuem biobancos devem ter atenção especial a este processo com para atender a padrões internacionais de boas práticas como o International Society for Biological and Environmental Repositories (ISBER), SBER best practices, ISO 15189, e Strengthening Laboratory Management Toward Accreditation SLMTA (CROXTON et al, 2020). Cada centro deve então adaptar sua realidade às exigências de cada protocolo.…”