Quality in Organ Donation V2

• Research type

  Research Tissue Bank

• IRAS ID

  237964

• Research summary

  Quality in Organ Donation (QUOD)

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  18/NW/0187

• Date of REC Opinion

  23 Apr 2018

• REC opinion

  Favourable Opinion

• Data collection arrangements

  Biological samples (blood, urine and tissues) are obtained from organ donors. Tissue samples procured include kidney, ureter, liver, bile duct, pancreas, spleen, heart and lung. Biopsies taken will not affect the use of the organs for transplantation. Whole organs i.e. heart, lung and pancreas are only taken when organs are not able to be transplanted.

  Samples are anonymised and identified only with the ODT number and the month and year of birth of the donor. Consent/authorisation is obtained from relatives or those in a qualifying relationship as defined by the Human Tissue Act. Written information is provided by the Specialist Nurse in Organ Donation.

  Samples are collected from 62 hospitals across the UK, 41 of which are located in England, Wales and Northern Ireland where an HTA licence (NHSBT 12608) covering the removal of biological samples from deceased individuals has been established. The other 21 hospitals are located in Scotland where the Human Tissue Act Scotland does not require an HTA licence for these activities.

  Upon collection, samples are transferred to 1 of the 9 QUOD centres in the UK, where they are processed (bloods and urine are rendered acellular and aliquoted in 0.5ml and 0.9ml aliquots), tissue samples are transferred to Oxford for further processing within 7 days of being collected. Serum and plasma and urine aliquots (non relevant HTA material) stay in the region until a monthly frozen shipment is organised to Oxford.

  In Oxford, tissue samples (as well as urine and blood aliquots) are held under the University of Oxford HTA licence 12217 at the John Radcliffe Hospital NDS. They are periodically transferred to the long term storage facility in Osney Mead, part of the UK Biocentre and stored under HTA licence 12624.

  Whole organs are taken to Newcastle or Oxford to be processed. Once the tissue processing and basic protocol is done, remaining samples are transferred back to Oxford and stored under licences 12217 and 12624.

• Research programme

  This initiative is coordinated by the Quality in Organ Donation(QUOD) Consortium. Led by Professor Rutger Ploeg from the University of Oxford, the QUOD Consortium includes Principal Investigators and Expert Advisers from academic institutions across the UK including: Voting Members: - QUOD Coordinating PI - 4 Platform Coordinators (Pancreas; Heart and Lung; Omics Technologies; Islets) - 11 Legal representatives from the contributing academic centres (Birmingham, Cambridge, Cardiff, Edinburgh, King's, Manchester, Newcastle, Leeds, Oxford, Royal Free & Papworth) - 5 NHSBT Representative (ODT Associate Medical Director; ODT Principal Statistician, Statistics and Clinical Studies; NHSBT Assistant Director, Research and Development; NHSBT ODT Operations; NHSBT National Deputy Clinical Lead for Organ Donation) - 2 Lay Members (from a pool of 7 available Lay Members) Advisory Members (non-voting): Advisory members provide scientifique critique, feedback and advice. - 5 NHSBT Transplant Advisory Group Representative (Cardiothoracic Transplantation; Kidney Transplantation; Liver; Pancreas Transplantation) - NHSBT Representative (Associate Director of Quality) - 3 Charities Representatives (Diabetes UK; Kidney Research UK; British Heart Foundation) - 5 Advisory members (Pathology Liaison; Research & Diagnostics Research Clinical Liaison; Clinical Liaison; ODT Research Liaison; ODT Operational Liaison) Supported by an initial £1.6 million grant from NHS Blood and Transplant, renewed in 2017 until March 2020 and an MRC extension grant of £1.7 million, in place until March 2021, this unique initiative has established itself and been recognised as the National Bioresource for decesed donation and transplantation accross the UK.

• Storage license

  12624

• RTBTitle

  Quality in Organ Donation (QUOD)

• Establishment organisation

  Nuffield Department of Surgical Sciences

• Establishment organisation address

  Level 6

  John Radciffe Hospital

  Oxford, UK

  OX3 9DU