Careful governance of African biobanks

The Sydney Statement is one of the first framing documents on the principles for guiding global health security. Framing matters because the funding pool for development assistance for health is finite and has plateaued over the past decade.2,3 Investments in global health security to prevent future catastrophes are subject to competing health priorities, such as scaling up the “most essential interventions” against ongoing epidemics of preventable morbidity and mortality in mothers, infants, and children in the Global South.4 Development assistance for health that prioritises global health security could overwhelm or detract attention from multiple competing health priorities.

The H3Africa policy framework: negotiating fairness in genomics

Human Heredity and Health in Africa (H3Africa) research seeks to promote fair collaboration between scientists in Africa and those from elsewhere. Here, we outline how concerns over inequality and exploitation led to a policy framework that places a firm focus on African leadership and capacity building as guiding principles for African genomics research

Challenges of biobanking in South Africa to facilitate indigenous research in an environment burdened with human immunodeficiency virus, tuberculosis, and emerging non-communicable diseases

The high burden of infectious diseases and the growing problem of noncommunicable and metabolic disease syndromes in South Africa (SA) forces a more focused research approach to facilitate cutting-edge scientific growth and public health development. Increased SA research on these diseases and syndromes and the collection of associated biospecimens has ensured a plethora of biobanks created by individuals, albeit without the foresight of prospective and collective use by other local and international researchers. As the need for access to high-quality specimens in statistically relevant numbers has increased, so has the necessity for the development of national human biobanks in SA and across the Continent. The prospects of achieving sustainable centralized biobanks are still an emerging and evolving concept, primarily and recently driven by the launch of the H3Africa consortium, which includes the development of harmonized and standardized biobanking operating procedures. This process is hindered by a myriad of complex societal considerations and ethico-legal challenges. Efforts to consolidate and standardize biological sample collections are further compromised by the lack of full appreciation by national stakeholders of the biological value inherent in these collections, and the availability of high quality human samples with well-annotated data for future scientific research and development. Inadequate or nonexistent legislative structures that specifically regulate the storage, use, dispersal, and disposal of human biological samples are common phenomena and pose further challenges. Furthermore, concerns relating to consent for unspecific future uses, as well as access to information and data protection, are all new paradigms that require further consideration and public engagement. This article reviews important fundamental issues such as governance, ethics, infrastructure, and bioinformatics that are important foundational prerequisites for the establishment and evolution of successful human biobanking in South Africa.Web of Scienc

A simple cost-effective high performance liquid chromatographic assay of sulphadoxine in whole blood spotted on filter paper for field studies

<p>Abstract</p> <p>Background</p> <p>Artesunate plus sulphadoxine-pyrimethamine is one of the four artemisinin-based combination therapies currently recommended by WHO as first-line treatment for falciparum malaria. Sulphadoxine-pyrimethamine is also used for intermittent preventive treatment for malaria in pregnancy. Drug use patterns and drug pharmacokinetics are important factors impacting the spread of drug resistant parasites hence it is imperative to monitor the effect of pharmacokinetic variability on therapeutic efficacy. Unfortunately, information on the pharmacokinetics of sulphadoxine in children and pregnant women with malaria is very limited. Methods for the assay of sulphadoxine-pyrimethamine have been previously reported, but they are not cost-effective and practicable in analytical laboratories in low resource areas where malaria is endemic. Efforts in this study were thus devoted to development and evaluation of a simple, cost-effective and sensitive method for quantification of sulphadoxine in small capillary samples of whole blood dried on filter paper.</p> <p>Methods</p> <p>Sulphadoxine was determined in whole blood by reversed-phase high performance liquid chromatography with UV detection at 340 nm. Sulisoxazole (SLX) was used as internal standard. Chromatographic separation was achieved using a Beckman Coulter ODS C₁₈and a mobile phase consisting of 0.05 M phosphate buffer-methanol-acetonitrile (70:17:13 V/V/V) containing 1% triethylamine solution.</p> <p>Results</p> <p>Standard curves from sulphadoxine-spiked blood added to filter paper were linear over the concentration range studied. Linear regression analysis yielded correlation coefficient r²> 0.99 (n = 6). Extraction recoveries were about 82-85%. The limit of quantification was 120 ng/ml while the within and between assay coefficient of variations were < 10%. The inter-day precision was < 5.8% and inter-day accuracy ranged from 4.1 to 5.3%. There was no interference from endogenous compounds or any of the commonly used anti-malarial, analgesic and anti-infective drugs with the peaks of SDX or the internal standard.</p> <p>Conclusion</p> <p>The recovery and accuracy of determination of SDX from whole blood filter paper samples using the method described in this study is satisfactory, thus making the method a valuable tool in epidemiological studies and therapeutic drug monitoring in developing endemic countries. Furthermore, the applicability of the method in studying the pharmacokinetic disposition of SDX in a patient suggests that the method is suitable in malaria endemic areas.</p

HIV/AIDS-related non-Hodgkin’s lymphomas and confounders: preliminary report of the Sub-Saharan Africa Lymphoma Consortium (SSALC)

CITATION: Ayers, L.W. et al. 2012. HIV/AIDS-related non-Hodgkin’s lymphomas and confounders : preliminary report of the Sub-Saharan Africa Lymphoma Consortium (SSALC). Infectious Agents and Cancer, 7(Suppl 1):P11, doi:10.1186/1750-9378-7-S1-P11.The original publication is available at http://infectagentscancer.biomedcentral.comSSALC was established to characterize HIV/AIDS-related lymphoma and the indigenous background of malignant lymphomas (ML) in sub-Saharan Africa. Because WHO classified lymphoma subgroups can vary in prevalence African, Asian or European ancestry, we surveyed lymphoma heterogeneity in geographically diverse East, South and West sub-Saharan populations, particularly for HIV/AIDS associated immunophenotypes.http://infectagentscancer.biomedcentral.com/articles/10.1186/1750-9378-7-S1-P11Publisher's versio

Addressing ethical issues in H3Africa research – the views of research ethics committee members

In June 2014, the H3Africa Working Group on Ethics organised a workshop with members of over 40 research ethics committees from across Africa to discuss the ethical challenges raised in H3Africa research, and to receive input on the proposed H3Africa governance framework. Prominent amongst a myriad of ethical issues raised by meeting participants were concerns over consent for future use of samples and data, the role of community engagement in large international collaborative projects, and particular features of the governance of sample sharing. This report describes these concerns in detail and will be informative to researchers wishing to conduct genomic research on diseases pertinent to the African research context

A perpetual source of DNA or something really different: ethical issues in the creation of cell lines for African genomics research

Background: The rise of genomic studies in Africa – not least due to projects funded under H3Africa – is associated with the development of a small number of biorepositories across Africa. For the ultimate success of these biorepositories, the creation of cell lines including those from selected H3Africa samples would be beneficial. In this paper, we map ethical challenges in the creation of cell lines. Discussion: The first challenge we identified relates to the moral status of cells living in culture. There is no doubt that cells in culture are alive, and the question is how this characteristic is relevant to ethical decision-making. The second challenge relates to the fact that cells in culture are a source of cell products and mitochondrial DNA. In combination with other technologies, cells in culture could also be used to grow human tissue. Whilst on the one hand, this feature increases the potential utility of the sample and promotes science, on the other it also enables further scientific work that may not have been specifically consented to or approved. The third challenge relates to ownership over samples, particularly in cases where cell lines are created by a biobank, and in a different country than where samples were collected. Relevant questions here concern the export of samples, approval of secondary use and the acceptability of commercialisation. A fourth challenge relates to perceptions of blood and bodily integrity, which may be particularly relevant for African research participants from certain cultures or backgrounds. Finally, we discuss challenges around informed consent and ethical review. Summary: In this paper, we sought to map the myriad of ethical challenges that need to be considered prior to making cell line creation a reality in the H3Africa project. Considering the relative novelty of this practice in Africa, such challenges will need to be considered, discussed and potentially be resolved before cell line creation in Africa becomes financially feasible and sustainable. We suggest that discussions need to be undertaken between stakeholders internationally, considering the international character of the H3Africa project. We also map out avenues for empirical research

Challenges in access and satisfaction with reproductive, maternal, newborn and child health services in Nigeria during the COVID-19 pandemic: A cross-sectional survey.

BACKGROUND: The presence of COVID-19 has led to the disruption of health systems globally, including essential reproductive, maternal, newborn and child health (RMNCH) services. This study aimed to assess the challenges faced by women who used RMNCH services in Nigeria's epicentre, their satisfaction with care received during the COVID-19 pandemic and the factors associated with their satisfaction. METHODS: This cross-sectional survey was conducted in Lagos, southwest Nigeria among 1,241 women of reproductive age who had just received RMNCH services at one of twenty-two health facilities across the primary, secondary and tertiary tiers of health care. The respondents were selected via multi-stage sampling and face to face exit interviews were conducted by trained interviewers. Client satisfaction was assessed across four sub-scales: health care delivery, health facility, interpersonal aspects of care and access to services. Bivariate and multivariate analyses were used to assess the relationship between personal characteristics and client satisfaction. RESULTS: About 43.51% of respondents had at least one challenge in accessing RMNCH services since the COVID-19 outbreak. Close to a third (31.91%) could not access service because they could not leave their houses during the lockdown and 18.13% could not access service because there was no transportation. The mean clients' satisfaction score among the respondents was 43.25 (SD: 6.28) out of a possible score of 57. Satisfaction scores for the interpersonal aspects of care were statistically significantly lower in the PHCs and general hospitals compared to teaching hospitals. Being over 30 years of age was significantly associated with an increased clients' satisfaction score (ß = 1.80, 95%CI: 1.10-2.50). CONCLUSION: The COVID-19 lockdown posed challenges to accessing RMNCH services for a significant proportion of women surveyed. Although overall satisfaction with care was fairly high, there is a need to provide tailored COVID-19 sensitive inter-personal care to clients at all levels of care