Secure specimen transfer from Ebola Biobank to the UK
Published 19 July 2019
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During the Ebola virus disease outbreak in 2013 to 2015 in Sierra Leone, Public Health England (PHE) established and operated 3 diagnostic laboratories: Freetown (Kerrytown), North West Sierra Leone (Port Loko Laboratory) and Central Sierra Leone (Makeni laboratory). They processed up to 300 clinical samples each day during the outbreak.
In 2015, most of the residual clinical specimens from routine diagnostic testing in the PHE-led laboratories were collected and transferred to PHE in the UK, leading to the establishment of the Ministry of Health and Sanitation in Sierra Leone (MOHS)-PHE Ebola Biobank with the approval of the Sierra Leone Government. The arrangements for their secure transfer to the UK are set out in the Pharmacy Board of Sierra Lione export permit
The remainder have been kept securely in Sierra Leone. The Ministry of Health and Sanitation in Sierra Leone (MOHS) retains ownership of the data and materials and is working with PHE and other researchers to develop and conduct a series of research projects that will inform future healthcare and public health strategies relating to Ebola.
The Biobank has been funded by a Wellcome Trust Bioresource grant and is a secure but accessible resource of biological samples that are essential for understanding human disease and the development of vaccines, diagnostics, and treatments. The MOHS-PHE Biobank samples are an especially valuable and finite resource, a legacy of the world’s largest ever outbreak of Ebola virus disease. Outbreaks of this disease continue in Africa, so it is evident that further biomedical research is required to more readily bring outbreaks under control.
The Ebola Biobank Governance Group (EBGG) was established to guarantee equality of access to the biobank for the most scientifically valuable research including by researchers from low and middle-income countries. It ensures that the resource is used for the global public good in accordance with the undertaking given by PHE to the MOHS and that the research will have relevance to the people of Sierra Leone.
The Group includes 3 members from Sierra Leone nominated by the Chief Medical Officer. Other members of the group represent the World Health Organisation, the Wellcome Trust, the UK Department for International Development and PHE with the Chair from the London School of Hygiene and Tropical Medicine.
The biobank is accessible to all researchers globally from academia, government other research organisations and commercial companies. Because the samples were collected during an outbreak, where the primary objectives were to deliver care and limit the outbreak, ethical approval for research was not collected from patients. So, in addition to EBGG approval, researchers wishing to use its samples need to obtain ethical approval from the Sierra Leone national ethics committee and from a local institutional ethics committee prior to receiving their samples.
Researchers can only access fully anonymised samples which are released with a material transfer agreement that guarantees the rights of the Sierra Leone government to any intellectual property developed during the research study and ensures the publication of all research results.
All samples are assumed to be highly infectious and will only be released, without further treatment, to researchers with documented access to Biosafety Level 4 facilities when all the appropriate permits are in place. Samples may be released when the risk of them containing live virus has been eliminated using a validated inactivation procedure. PHE’s work includes a commitment to support research into the effective management of future disease outbreaks.
The MOHS-PHE biobank is housed in facilities suitable for the storage and processing of high-risk biological samples that require specialist handling by highly trained competent staff in appropriate laboratories. Within these facilities, protocols are used for the inactivation of Ebola virus and other high-risk pathogens potentially contained in the samples, so they may be shared with researchers globally who lack access to such facilities.