Autmn 2005
UK Children's Cancer Study Group (UKCCSG)/
UK Childhood Leukaemia Working Party (UKCLWP)
Childhood Tumour and Leukaemia Bank
The UKCCSG has operated a virtual tissue bank since 1998, giving researcher access to tissue from paediatric oncology patients. The tumour banking protocol describes the internal structures of the tumour bank and the method by which material can be made available to researchers. It doesn't however describe any research projects. These are detailed in specific biological study applications which require both scientific and ethical approval before material is released.
As with any trial, informed consent is the foundation of the protocol. Through standard patient information sheets, and discussion with a local investigator it is explained that the donation is of tissue surplus to diagnostic requirements for biological research and allowing access to anonymised clinical data. What is made very clear is that tumour samples will only be used for scientifically approved and ethically approved research projects. It is also explained that the work will be carried out completely anonymously by the researchers, with a coded link held at the UKCCSG Data Centre to provide clinical information. As the majority of the tissue in the bank is from patients under the legal age of consent, it is the parents or guardians that grant consent for the use of their children's tissue. Parents are therefore reminded that it is their responsibility to make their children aware of this donation and of their right to withdraw consent when legally old enough to make that decision.
More specifically, the Tumour Banking consent form requires the patient/parent to (a) confirm they have read and understood the information sheets provided and have had the opportunity to ask any questions, (b) understand that this is voluntary, and can withdraw at anytime, (c) agree to medical notes being held in the strictest confidence at the UKCCSG Data Centre or the UKCLWP Data Centres, (d) agree to data being sent to countries with different data protection laws, but that no patient identifiable information will be sent and (e) that they agree to blood, tumour, bone marrow and other tissue being stored and used for current and future research projects relating to childhood cancer locally, nationally and internationally.
A scientific review of research projects is co-ordinated by the UKCCSG Division of Biological Studies. Based on detailed reports of internationally renowned research scientists, both internal and external to the UKCCSG, along with the opinions of the other members of the Division, a project is either approved, approved subject to amendment/clarification or rejected. This scientific review ensures that only the very highest calibre research projects have access to material from the tissue bank, ensuring the careful use of this invaluable resource. It also allows both local and national research to be carried out. Once approved, studies still require ethical approval to obtain the material.
As the samples are from a virtual tissue bank from patients in many different NHS Trusts, ethical approval for the research is required from an MREC (usually Trent MREC). This is co-ordinated at the UKCCSG Data Centre in Leicester, in collaboration with Chief Investigator of the project. As gaining consent, releasing material etc already has ethical approval, this is not usually a complex process.
One of the safety mechanisms built into the UKCCSG/UKCLWP Childhood Tumour and Leukaemia Bank is an annual review of all research projects. By submitting an annual report to the Division of Biological Studies, the Division is able to evaluate progress made in each research project thus ensuring tissue is used in the most efficient manner.
For further details about the UKCCSG/UKCLWP Childhood Tumour & Leukaemia Tissue Bank please refer to www.ukccsg.org.uk or email gavin.whyman@leicester.ac.uk