by Balwir Matharoo-Ball
The Nottingham Health Science Biobank (NHSB) and related bioinformatics strategy as a platform for excellence in translational and clinical research is led by Dr Brian Thomson Director of Department of Research and Innovation (R&I) and the NHSB. This is a Trust led Biobank which is working closely with the Biomedical Research Units (BRUs), University of Nottingham and Nottingham NHS Treatment Centre on behalf of the wider scientific community. The aim is to provide a single, centralised, quality assured, biofluid and tissue resource to underpin translational studies in the Trust and University and to provide added value to clinical trials. Health research is one of the founding principles of the NHS; it is critical for improved quality of life and more effective healthcare delivery. The NHSB is a unique facility which will take advantage of our very large and diverse patient population, which is a key strength of Nottingham as a future centre for research excellence.
Dr Balwir Matharoo-Ball has been appointed as Operations Manager for the NHSB and heads a team based in the Department of Pathology which consists of 8 scientists, 2 data analysts and a consent nurse who are sited at the David Evans Medical Centre at the City campus and at QMC.
Ethical approval for generic consent for prospective collections and for the use of Pathology archival material has been granted by the Greater Manchester National Research Ethics Service. The NHSB ethical approval allows the collection of biomaterials from patients attending any inpatient or outpatient environment in the Trust. Tissue which is excess to diagnostic requirements, together with additional volume of blood or other body fluids collected during routine patient treatment, will be gathered prospectively and used for approved research projects.
Patient and Sample Clinical Pathways
The NHSB is currently piloting patient and sample pathways in Breast and Respiratory clinics at City campus, Liver clinics at QMC and GI/Liver at the Nottingham NHS Treatment Centre. Since the pilot started in February 2011, over 900 patients have been consented and over 1100 samples collected. NHSB consent alerts have been set up on NotIS to ensure that patient information and consent forms are not being sent to patients already consented or who have declined consent. The Trust consent committee has also approved the addition of the NHSB generic consent for ethically approved research as part of the consent to treat form.
Breast Cancer Campaign Tissue Bank (BCCTB)
Breast tissue collected by the Biobank is being donated to The Breast Cancer Campaign, a national initiative where tissue samples donated by patients from across the UK are available to scientists to study how and why breast cancer develops and spreads, and to devise the best possible treatments. There is currently no other large source of breast tissue available to scientists and doctors anywhere in the world. Nottingham is one of four core centres supporting this campaign.
Laboratory Information Management System (LIMS)
The Sapphire Biobank management system from LabVantage has been procured, configured, and installed on the Trust network to support the pilots. The Trust provides support, failover and backup facilities from their computer centre. This system provides a database resource with a browser access available across the Trust to hold details of: the consenting process; relevant clinicopathological data; tracking the samples; managing freezer storage; sample processing; research studies; and providing full reporting and analysis on all data. The system complies with all legal and regulatory requirements such as Caldecott recommendations, the Data Protection Act, and the Human Tissue Act. Design has commenced on providing messages from the hospital systems to Sapphire for patient demographics and test results. These interfaces will be developed by Trust ICT Services during the remainder of this year.
A full function Biobank management system is currently being procured for roll out under the guidelines of the Office Journal of the European Union (OJEU). This system will support the launch of the Biobank to other translational and clinical groups, including pharmaceutical companies.
Patient data is a key underpinning resource for any form of clinical research. Current NHS ICD-10 and SNOMED coding systems contain vast amounts of information but are difficult either to access or interrogate. The Trust has developed a novel patient informatics system (ORCHID) which permits linkage of stored biomaterial to carefully phenotyped patient data and the accumulating hospital record. ORCHID captures patient data generated in routine clinical practice and orders it in a manner which can be searched and interrogated for research purposes. Both NHSB and the patient informatics are managed by a common IT system which will be shared with the University of Nottingham. ORCHID is being implemented using an open source software platform and healthcare standards, which will allow it to be easily used by other organisations if required, and has been developed by Dr Ian Gaywood and Dr Ira Pande from NUH and Professor John Chelsom from the Department of Health Informatics, City University, London in collaboration with NUH Research and Innovation.
A Biobank web site is being developed. As well as content describing the Biobank and its services it is also planned to provide web access for researchers, located anywhere in the world, to have a unified view of samples held in the Biobank and the anomymised clinical data held in ORCHID.
Patient Public Involvement (PPI) approach
A new and innovative patient consent pathway is being piloted and further developed by the NHSB in the Breast Institute with the help of the Biobank PPI Advisory Group comprising volunteer patients, carers and the public.
We aim to ensure:
Members of the PPI Advisory Group will receive full Trust induction and NHSB training on consent and other governance issues. The NHSB PPI approach fulfils one the key initiatives as we move to becoming a Trust Foundation.