PRECISE pregnancy cohort: challenges and strategies in setting up a biorepository in sub-Saharan Africa

Abstract

Background and objective: PRECISE is a population-based, prospective pregnancy cohort study designed for deep phenotyping of pregnancies in women with placenta-related disorders, and in healthy controls. The PRECISE Network is recruiting~10,000 pregnant women in three countries (The Gambia, Kenya, and Mozambique) representing sub-Saharan Africa. The principal aim is to improve our understanding of pre-eclampsia, fetal growth restriction and stillbirth. This involves the creation of a highly curated biorepository for state of the art discovery science and a rich database of antenatal variables and maternal and neonatal outcomes. Our overarching aim is to provide large sample numbers with adequate power to address key scientific questions. Here we describe our experience of establishing a biorepository in the PRECISE Network and review the issues and challenges surrounding setup , management and scientific use. Methods: The feasibility of collecting and processing each sample type was assessed in each setting and plans made for establishing the necessary infrastructure. Quality control (QC) protocols were established to ensure that biological samples are 'fit-for-purpose'. The management structures required for standardised sample collection and processing were developed. This included the need for transport of samples between participating countries and to external academic/commercial institutions. Results: Numerous practical challenges were encountered in setting up the infrastructure including facilities, staffing, training, cultural barriers, procurement, shipping and sample storage. Whilst delaying the project, these were overcome by establishing good communication with the sites, training workshops and constant engagement with the necessary commercial suppliers. A Project Executive Committee and Biology Working Group together defined the biospecimens required to answer the research questions paying particular attention to harmonisation of protocols with other cohorts so as to enable cross-biorepository collaboration. Governance structures implemented include a Data and Sample Committee to ensure biospecimens and data will be used according to consent, and prioritisation by scientific excellence. A coordinated sample and data transfer agreement will prevent delay in sample sharing.

Early-life chemical exposome and gut microbiome development: African research perspectives within a global environmental health context

“…This is especially challenging for chemical exposome-microbiome research as repeated sampling of food and multiple biospecimens could be required from a single participant over a longer time period (e.g., in longitudinal sampling design). Cultural barriers may limit the collection of samples for research purposes [68]. In South Africa, 25 out of 200 participants expressed strong concerns and objection to export of their blood samples abroad, with some citing concerns about the use of their blood for rituals [69].…”

“…Moreover, the atmosphere of mistrust that exists in some African communities [72] could be linked to past research misconduct by a few western researchers [73], which further compounds the problem of biological sample collection. The situation becomes more complicated when samples are to be collected from NITs, or participants are to be recruited during pregnancy [68]. Pregnant women are sometimes very critical and may express superstitious fear of harm to the unborn child.…”

“…Educating prospective participants Continuous education is needed to enlighten prospective participants about the importance of participating in biospecimen-based research [68], such as holistic chemical exposomemicrobiome relationships. Researchers should consider consulting and involving prospective households and target communities during the planning phase of the study [79].…”

Harnessing the PRECISE network as a platform to strengthen global capacity for maternal and child health research in sub-Saharan Africa

“…A major legacy of the PRECISE programme will be the establishment of combined pregnancy multidimensional databases and biorepositories in Kenya, The Gambia and Mozambique [11,12]. The combination of biological samples and extensive phenotypic data will enable new research into the biological pathways and co-exposures that cause, confound and affect the impact of placental disease (i.e., pre-eclampsia, fetal growth restriction, preterm birth and stillbirth) in sub-Saharan Africa.…”

“…1) is funded by the UKRI GCRF GROW call which had the specific aim of developing "research capacity around the globe and to strengthen and broaden skills and expertise to address specific challenges of developing regions and countries" [1]. As is shown by the first four papers in this BMC Reproductive Health Supplement, An Introduction to The PRECISE Network [10][11][12][13], this programme of work aims to achieve capacity building through the development of an international team that will set-up a pregnancy biobank and develop a holistic data set to enable deep phenotyping of factors affecting placental disease in three sub-Saharan African settings. This is summarised in the first of the four PRECISE Network aims, "Build individual and institutional research capacity across Africa and the UK through a shared pregnancy research programme of work" [14].…”