07/MRE09/23

REC for Wales

Institute of Life Science, School of Medicine, Swansea University

Wales Epilepsy BioBank (eBioBank)

Wales Epilepsy BioBank (eBioBank)

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Permission to publish contact details not yet received

Blood samples will be taken from all idiopathic, syndromic and acquired epilepsy patients in Wales (eBioBank) as part of a programme of sheduled research within the Wales Epilepsy Research Network (WERN). The blood sample will be used to create a DNA sample that will be banked for a wide range of biomedical and genetic investigations. In addition, a small amount of the blood will be used to create a lymphocyte cell pellet which will be banked to provide capacity to create immortal cell lines for research. No other tissue-type will be collected and the DNA and cell pellets have approximately 20-30 year viability under their storage conditions. Over a ten year period it is hoped that 20,000 samples will be collected for eBioBank at a rate of 2,000 per anum by regional WERN field-teams (funded by WORD and CRC-Cymru).

Demographic and clinical/medical data will be collected from patients and tertiary Neurology clinics and stored in WERN Databases. In addition data will be anonymised-linked to other health informatics databases as part of carefully-constructed collaborations. The data will be sourced from medical notes, patient information from clinic visits and the perceptions of the consultant physicians. This will be a consent driven process and patients will be approached by health professionals to explain the purposes of the sample and data collection. Data will be kept in one of 5 regional database hubs within Wales which are located within epilepsy/neurology units under the guidance of WERN, the local custodian (consultant epileptologist) and the data protection officer at each site.

Samples will be derived from the living only.

The existence of, and recruitment into, the eBioBank will be publicised from within tertiary NHS clinics specialising in epilepsy conditions. There will be no external public call or donation appeal.

The DNA samples have several sheduled purposes:

1) Gene-discovery experiments: using gene association studies, linkage analysis, and candidate gene screening.
2) Pharmacogenomics: the association of genetic constitution with response to drugs or susceptibility to side-effects.
3) Submission of specific DNA cohorts (epilepsy has over 50 clinical sub-types) to academic research facilities as part of formal collaborations (including material transfer agreements).
4) Submission of specific DNA cohorts to Pharmaceutical companies who require biological material to develop and test new anti-seizure drugs.

The lymphocyte cell pellet repository has two main shedules:
1) To provide a source of mRNA to test in gene expression studies, including microarray work.
2) Provide a resource to establish immortal cell lines for an inexhaustible supply of DNA, RNA and cellular fractions. In both cases, novel experimental results from the genetic studies (and novel literature) will trigger the utilisation of the cell pellet.

All sheduled purposes are aimed towards better understanding epilepsy and how to treat it, thus benefiting epilepsy patients and society in general.

There are two statements on the consent forms which we bring to your attention. The first is that we will request that the data collected be centralised and cross-referenced with other databases within the Health Informatics Research Unit (HIRU) at Swansea Medical School. The second is that data as well as samples can be anonymously passed on to academic collaborations and pharmaceutical companies for specific and focused studies. This maximises the use of the samples and data donated to the eBioBank and therefore maximises the benefits.

The eBioBank is a free resource for academic collaborations, however, pharmaceutical companies will be charged for samples. Our policy on financial gain is that it is diverted into WERN and the sustainability of the eBioBank costs.

The majority of returnables from the eBioBank collection will be in anonymised cohort-driven academic publications, grant applications and conference proceedings. Progress will also be reported to WERN executive committee and to CRC-Cymru / WORD / Welsh Assembly.

The research will be conducted on DNA samples or products from cell lines derived from all-types of epilepsy, including co-morbidity with paroxysmal movement disorders, neuronal migration disorders and psychiatric disorders. The aim is for the samples to be part of basic research, experimental medicine and clinical translation work in neurology. Specific types of research are Neurology, Human Molecular Genetics, Pharmacogenomics and Neuroscience / Neurobiology. General themes include biobanking, gene-hunting, and translational research.

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