08/H0304/85

Cambridgeshire 1 Research Ethics Committee

Norfolk and Norwich University Hospital NHS Foundation Trust

Partners in Cancer Research Human Tissue Bank

Partners in Cancer Research Human Tissue Bank

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The Partners in Cancer Research Human Tissue Bank was established primarily to support local biomedical research, particularly into the development, diagnosis and treatment of malignant disease ("cancer"). We collect samples of tumours and non-tumour tissue mainly from patients with various types of cancer, particularly of the breast, kidney, bladder, prostate, testis, female genital tract, large intestine, and head and neck region. There are smaller holdings of malignant lymphomas and other types of tumour.

The material retained within the Human Tissue Bank is predominantly fresh-frozen tissue, which is maintained at -80C. We also store blood samples from some patients. Once frozen, the material should remain useful for research indefinitely. Some specimens are acquired by the bank for physiological studies (for example, into intestinal muscle function). They are perishable and are immediately dispatched to the research laboratory by courier for research studies.

The number of donations varies considerably from year to year, depending on research activity and the enthusiasm of clinical colleagues for requesting donation. In good years, we received donations from several hundred patients. Each donation would provide several samples, amounting to a few thousand per annum.

As for accrual of tissue, its usage varies considerably according to research need. In good years, several hundred samples are disbursed to research workers for study.

The Tissue Bank has a dedicated database upon which we maintain records of donations. Most of the information we store is derived from either the request form that accompanies the specimen (tissue donation)to the laboratory or from the surgical histopathology report that follows the processing and reporting of the specimen. We do not question patients (donors) to obtain this information.

Details stored on the database include information about the donor (for example, name, date of birth, hospital number, Tissue Bank acquisition number, related laboratory report number, and so on) and about the specimen itself (for example, site and type of tumour, its grade and stage, and so on). Our database allows linkage, as required, to the patient record with acquisition by appropriate Trust employees of outcome data over the course of time, as required. The database is secure and very few people, including the biomedical scientist who maintains it and hisdeputies, have access. No patient-identifiable data are released when samples are sent for research.

If the research project demands follow up data, particularly of prognostic significance, that may be obtained from the donor's hospital record by an appropriately qualified person employed by the hospital trust. The current version of the Human Tissue Bank consent form allows for such scrutiny of the case records.

We do not normally collect samples from the dead, but do so on rare occasions for particular purposes (for example, to investigate the possibility of an inherited disease as part of a post mortem examination). If such samples are taken, it is with the agreement of HM Coroner for medico-legal post mortem examinations and with that of the next of kin for clinical (consented) post mortem examinations. In all cases acquisition conforms to the terms of the Human Tissue Act 2004.

We do not store samples from the dead routinely for the purposes of medical research. That possibility does exist for particularly rare or interesting cases. If such a situation arose, the collection, storage and release of tissue for research would be to the same standards as for donations from the living.

Samples from the dead are recorded on the Human Tissue Bank database as described above. Appropriate staff (for example, the pathologist undertaking the post mortem examination) would have access to the donor's hospital medical records and other relevant documentation.

The Partners in Cancer Research Human Tissue Bank exists for the benefit of society at large and was established primarily to foster biomedical research in Norwich.

We release donated samples to bona fide researchers (who are mainly university- or research institute-based), particularly those working in Norwich (mainly at the University of East Anglia - UEA - and Institute of Food Research - IFR), but also further afield, including the commercial sector (Asterand UK Ltd), to support appropriate projects aimed at a greater understanding of the development of disease (particularly "cancer"), with a view to improving diagnosis and treatment.

Applicants for tissue samples from the Partners in Cancer Research Human Tissue Bank must have appropriate approvals from a research governance committee and from a research ethics committee before applying. Our own supervising Tissue Bank Committee then critically assesses the request, particularly from the view of scientific validity and ethical considerations, before deciding whether to approve or reject the application. We take account of whether any donation will adversely affect our local research effort, by depleting our own holdings, as that is the primary purpose for the Bank. However, we are quite happy to develop research collaborations with colleagues elsewhere, if the proposed programme is congruent with our own research interests.

We do not, of course "sell" donations, but we do expect any commercial partners to support the work of the Human Tissue Bank by reimbursing our costs in obtaining, processing and maintaining the donations. Academic partners, particularly those in Norwich, are able to obtain samples at no cost. However, we do encourage them to include an element of Human Tissue Bank funding into their grant applications in order to provide additional funding to support our work.

The Partners in Cancer Research Human Tissue Bank Committee has decided, as a matter of policy, to restrict the use of tissue donations to countries that are bound by the Human Tissue Act 2004 or that have legislation in place that demands similar standards of handling, processing and use of human tissue donations. Such restrictions are enshrined in legally binding deeds, as necessary.

We permit a variety of different methods to be used with our donations, including genetic analysis (DNA and RNA). At present, cloning is expressly forbidden. The potential uses of donations are described in broad terms to donors and are inclued on the information sheet that they receive. When we release tissue for research projects, we take account of each donor's wishes, as indicated on the consent form.

Donations are sought from patients attending the Norfolk and Norwich University Hospitals NHS Foundation Trust and the James Paget University Hospitals NHS Foundation Trust. The request is usually made by a doctor in the clinical team or by a senior (and properly trained) nurse practitioner.


We undertake many collaborative projects, the results of which are published in peer-reviewed journals, so that others can make use of our new knowledge in their own work. Our first paper discussed, inter alia, ethical aspects of tissue donation to the bank. Please see: AC Riddick, C Barker, I Sheriffs, R Bass, V Ellis, KK Sethia, DR Edwards, RY Ball. Banking of fresh-frozen prostate tissue: methods, validation and use. B J Urol Int 2003; 91: 315-323.

We do not inform patients of the experimental results obtained from their individual donations. Occasional local endeavours, such as talks or poster presentations, are used to spread knowledge of the work of the Bank and to inform the public at large of the results we obtain from donations and how they might influence future research and patient care.

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