Human Tissue Research at UWE 1. The Quality Management System 1 Release Version 1.2 18 June 2018 Contents 1. Introduction to the Quality Management System ................................................................ 3 2. The UWE Human Tissue Operating Procedures and Guidance for Staff and Students ............. 4 3. The UWE Human Tissue Records Management Manual ....................................................... 5 4. The UWE Human Tissue Standard Operating Procedures..................................................... 5 5. Contact for further details ................................................................................................ 6 2 Release Version 1.2 18 June 2018 Introduction to the Quality Management System In line with Medical Research Council guidelines (www.mrc.ac.uk/news- events/publications/human-tissue-and-biological-samples-for-use-in-research/), UWE is developing a Quality Management System (QMS) for the management of human tissue research at UWE. The UWE Human Tissue Quality Management System is laid out in the documentation within the following three areas: The UWE Human Tissue Operating Procedures and Guidance for Staff and Students, The UWE Human Tissue Records Management Manual and the UWE Human Tissue Standard Operating Procedures. The relationship between these three areas is illustrated in the diagram below: 3 Release Version 1.2 18 June 2018 The QMS will define appropriate quality systems in the collection, processing, storage and disposal of human tissue at UWE. The QMS will use a combination of procedures and records to ensure that: Researchers know what is expected of them if they wish to undertake human tissue research at UWE Researchers understand how human tissue research projects at UWE should be managed Researchers understand how any human tissue samples being stored on UWE premises should be managed. The QMS will allow Research Managers to: quickly and easily identify what human tissue research is taking place at UWE quickly and easily identify any human tissue samples that are being stored on UWE premises demonstrate good practice in the management of Human Tissue research is taking place at UWE. Whilst we recognise that the NHS REC does not require this level of records management for human tissue research, we are moving towards the standards required to be a Human Tissue Authority licensable establishment, therefore once this Quality Management System is approved, this represents UWE’s view of best practice, and must be in place for all new and ongoing projects. The UWE Human Tissue Operating Procedures and Guidance for Staff and Students The UWE Human Tissue Operating Procedures and Guidance for Staff and Students set out the University’s requirements in relation to the ethical review, oversight and management of Human Tissue Research. They can be found at: http://www1.uwe.ac.uk/research/researchgovernance/resourcesforresearchers/humanti ssueresearch.aspx Background information about the Human Tissue Act (2004) and its Codes of Practice are also laid out in these procedures, along with further information about what is considered a ‘relevant material’ under the Act, and Human Tissue Authority (HTA) licencing requirements and exemptions. 4 Release Version 1.2 18 June 2018 UWE does not currently hold an HTA licence for storage of human tissue for research purposes (as defined by the Human Tissue Act). This means the licensable storage of relevant material for research at UWE must be covered by a valid, in date, NHS Research Ethics Committee favourable opinion for a specific research project, or covered by the NHS REC approval of a Research Tissue Bank, prior to human tissue being brought on to UWE premises. The UWE Human Tissue Records Management Manual The UWE Human Tissue Research Records Management Manual sets out expectations of the records that need to be kept by UWE Project Managers, by Laboratory Managers and by central Research Governance and Ethics teams, and by individual researchers working on Human Tissue projects in support of the Quality Management System. The Manual can be found at: http://www1.uwe.ac.uk/research/researchgovernance/resourcesforresearchers/humanti ssueresearch.aspx and includes: Procedures for recording Human Tissue research at UWE – The UWE Human Tissue Research Register Requirements for maintaining project level information by the UWE Project Manager – The Project File Procedures for managing and recording the locations where human tissue samples are stored at UWE – Individual Sample Labelling, Sample Location Notices, Sample Ledgers. The UWE Human Tissue Standard Operating Procedures The UWE Human Tissue Standard Operating Procedures set out detailed procedures for how certain standard processes related to human tissue research should be managed at UWE. The Standard Operating Procedures can be found at: http://www1.uwe.ac.uk/research/researchgovernance/resourcesforresearchers/humanti ssueresearch.aspx and cover: The Transport of Human Tissue onto UWE Premises Disposing of Human Tissue Samples at UWE The UWE Human Tissue Subcommittee Audit Policy and Guidelines 5 Release Version 1.2 18 June 2018 Contact for further details For further information and guidance on conducting research using human tissue at UWE, please contact the Officer of the Human Tissue Subcommittee: [email protected]. Document Owner: Ros Rouse (Research Governance Manager) 6 Release Version 1.2 18 June 2018 Human Tissue Research at UWE 2. Operating Procedures and Guidance for Staff and Students 7 Release Version 1.2 18 June 2018 Contents Key Messages ........................................................................................................................ 9 1. Introduction ................................................................................................................... 10 2. Scope ............................................................................................................................ 10 3. Expectations of UWE Researchers .................................................................................... 10 4. What is Good Practice in Human Tissue Research? ............................................................ 11 5. Governance and Formal Communication ........................................................................... 12 6. What is the Human Tissue Act? ........................................................................................ 13 7. What is human tissue and what is relevant material? ......................................................... 14 8. Consent ......................................................................................................................... 19 9. Storage of Human Tissue at UWE for research purposes: Legal Compliance and Exemptions. ................................................................................................................... 25 10. Requirements for UWE Researchers working with HTA relevant materials not on UWE premises… ..................................................................................................................... 33 11. Ethical Approval for research ........................................................................................... 35 12. Staff volunteers .............................................................................................................. 42 13. Contractual arrangements with funders and collaborators .................................................. 44 14. UWE Human Tissue Research Register ............................................................................. 45 15. Documentation and record keeping .................................................................................. 45 16. Transport of Relevant Materials........................................................................................ 46 17. Disposal of Relevant Material ........................................................................................... 46 18. Serious Adverse Events ................................................................................................... 47 19. UWE Human Tissue Sub-Committee Audit Policy and Guidelines ......................................... 49 20. Licence Quality Standards................................................................................................ 49 Annex 1 ............................................................................................................................... 50 Annex 2 ............................................................................................................................... 52 Annex 3 ............................................................................................................................... 54 Annex 4 ............................................................................................................................... 58 Annex 5 ............................................................................................................................... 66 NB: This guide does not cover the use of tissue in teaching or public display. These will be the subject of separate guidance. 8 Release Version 1.2 18 June 2018 Key Messages Ethical review is always necessary for human tissue research All research at UWE that involves human tissue (relevant or non-relevant materials) must be registered on the UWE Human Tissue Research Register The UWE Project Manager is responsible for the good conduct of their human tissue research