Vasculitis and Inflammation Integrated Research Tissue Bank (VII RTB)

• Research type

  Research Tissue Bank

• IRAS ID

  265891

• Research summary

  Vasculitis and Inflammation Integrated Research Tissue Bank (VII RTB)

• REC name

  Wales REC 4

• REC reference

  20/WA/0195

• Date of REC Opinion

  6 Jul 2020

• REC opinion

  Favourable Opinion

• Data collection arrangements

  All samples will be stored at HTA licensed premises of the University of Leeds in compliance with the licensing provisions of the Human Tissue Act (2004) and in accordance with joint University/Trust policies which are fully compliant with the regulatory authorities for biobanking and information security. Governance of the RTB will be enforced by the RTB’s Research Management Committee which oversees all aspects of the tissue bank, ensuring full compliance with the law, regulatory constraints, and ethics committee approvals.

  Fluid and tissue samples will be collected and processed by appropriately trained research staff in dedicated sample processing labs, most of which are run in accordance with Good Clinical Laboratory Practice (GCLP). Samples from non-licensed collection centres will be transported to licensed premises within 7 days.

  Informed consent will be obtained by members of the healthcare team or appropriately trained staff with honorary NHS or honorary NHS contracts, in accordance with NHS procedures. Eligible participants will be approached with study specific information sheets and a consent form. Full explanations will be provided and the patient will be given as much time as they need to make an informed decision about whether or not they would like to participate. Associated clinical data will be stored in information governance compliant systems ensuring data security and confidentiality.

• Research programme

  The RTB will support research in a range of diseases associated with vasculitis, autoimmune or inflammatory disorders. The basic scientific and clinical areas supported include the field of vasculitis (in particular giant cell arteritis, Behçet’s syndrome and polymyalgia rheumatica), though data and samples from patients with other autoimmune and inflammatory disorders relating to our other research interests in FcƔ receptor biology (e.g. inflammatory arthritis and other autoantibody-mediated diseases) or glucocorticoid toxicity will also be included. Data and samples will be used in a variety of local, national and international research projects and programmes. Funding sources for these include the Medical Research Council, the NIHR, EU Horizon 2020, the Wellcome Trust, Vasculitis UK and Roche Products Ltd. Samples from healthy control patients have also been collected, genotyped, and subjects may be recalled for functional studies in the future.

• Storage license

  12352

• RTBTitle

  Vasculitis and Inflammation Integrated Research Tissue Bank (VII RTB)

• Establishment organisation

  University of Leeds/ Leeds Teaching Hospitals NHS Trust

• Establishment organisation address

  LIGHT Laboratories/St James's University Hospital

  Clarendon Way/Beckett Street

  Leeds/Leeds

  LS2 9DA/LS9 7TF