UNIVERSITY OF LEICESTER, UNIVERSITY OF LOUGHBOROUGH & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH & DEVELOPMENT SUPPORT OFFICE

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1 UNIVERSITY OF LEICESTER, UNIVERSITY OF LOUGHBOROUGH & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH & DEVELOPMENT SUPPORT OFFICE STANDARD OPERATING PROCEDURES University of Leicester (UoL) Governance Office SOP HTA-1004 UoL Coding and Tracking of Human Tissue Samples in Within the University of Leicester (UoL) OFFICE BASE Governance Office University of Leicester Academic Department Leicester General Hospital Gwendolen Road Leicester LE5 4PW Version 2 Effective Date: September 2018 SOP HTA-1004-UoL Version 2 July 2018 Page 1 of 5

2 Standard Operating Procedure: HTA-1004 UoL Coding and Tracking of Human Tissue Samples in Within the University of Leicester (UoL) Governance Office July Background This document has been produced in accordance with The Human Tissue Act 2004 (HT Act). It should be read in conjunction with the University s Policy on compliance with the Human Tissue Act in research, and the Human Tissue Authority s (HTA) Codes of Practice. The procedures represent good practice for the handling of all tissue samples and other types of relevant material as defined by the HTA. They must be followed by all researchers working under the University s Licence from the HTA and those transferring tissue as part of an ethically approved research project. The procedures outlined in this document represent best practice for the handling of all research tissue samples on university premises in accordance with the Human Tissue Act To comply with the HT Act it is necessary to ensure that there is a clear and robust audit trail from the collection of human material, through processing, storage, use and distribution, to final use/disposal. All human material acquired by university personnel for storage under a HTA licence must be recorded and its use, distribution and disposal accounted for. 2 Purpose This document aims to provide guidance for Persons Designate (PD), and staff working under their direction so that they are fully aware of the procedures needed to ensure that the requirements for coding and tracking of human material under the HT Act and HTA Codes of Practice are met. 3 Roles and Responsibilities 3.1 Designated Individual (DI) - Accountable to the Human Tissue Authority for research tissue stored under the authority of the University Licence and for making relevant University staff aware of this document. 3.2 Persons Designated (PD) - Accountable to the DI and responsible for ensuring that this document is observed in respect of human tissue for which they have responsibility and is stored under the authority of the university Licence. This includes making all staff that collect, store or use such tissue aware of this document. 3.3 All staff collecting, storing or using human tissue for research under the University HTA Licence are accountable to the relevant PD(s) and the DI for undertaking work in compliance with this document. In compliance with the SOP HTA-1004-UoL Version 2 July 2018 Page 2 of 5

3 4 Procedure Licence issued by the HTA, the University of Leicester expects all persons operating on the university sites to comply with the HT Act and its subsequent amendments, and to seek to comply with all Codes of Practice issued by the HTA and relevant university wide and/or local Standard Operating Procedures (SOPs). 4.1 Sample Tracking Software/Laboratory Databases Paper records, password protected databases and records systems must be used by individual labs to record all data related to the storage and use of human tissue samples. All sample tracking systems and laboratory databases must be available for audit by the DI and Governance Office All sample tracking systems and databases must provide a full audit trail of sample storage, use, transfer and disposal. Sample tracking software is a robust alternative to spreadsheets and paper records and would be encouraged be used wherever possible e.g. Open Specimen. An example paper sample tracking log is shown in Appendix Sample coding and tracking An audit trail must be maintained when tissue is collected. When samples enter the collection, the PD/researcher should record all aspects of their storage, use and fate. The sample should be anonymised by assigning a unique number/identifier that is linked to the original information kept securely in the licensed premises. All subdivisions of the sample should be identified with reference to the master sample Samples must be labelled appropriately for the storage conditions. Printed adhesive labels should be used wherever possible. Ensure to use a permanent pen/marker when completing handwritten labels i.e. loss though exposure to moisture and solvents etc Information recorded for each sample should include: Sample type Unique sample identifier Date of collection Custodian of the sample Consent type (project specific, generic, none) Collection centre / providing establishment or organisation Physical location within the bank/collection SOP HTA-1004-UoL Version 2 July 2018 Page 3 of 5

4 Details of any ethics approval for use No data that would allow the donor of the sample to be identified should be printed on the sample container When material is used, transferred or disposed of, this information must also be recorded either using paper records, sample tracking software or password protected laboratory databases A log of all material stored must be maintained by the PD or custodian of the collection. This data will be audited and checked against the stored material for accuracy Records of transportation and delivery should be kept including any agreements with courier or transport companies and recipients of relevant material. 5 Departmental Sample Log Audits It is recommend that departments audit their own sample logs on a regular basis to ensure all data is kept up to date and error free (refer to SOP HTA-1006). 6 Responsibilities Responsibility Undertaken by Activity All Individuals. 1. Designated Individual (DI) 2. Designated Individual (DI) Governance Office Ensure that there is a clear and robust audit trail from the collection of human material, through processing, storage, use and distribution, to final use/disposal. Notify PD, DI and Governance Office of any of a breaches of the HTA standards. Ensure HTA compliance by auditing sample logs regularly and keep records of such audits and develop audit schedule. Provide support in suitability of sample storage systems. Report critical errors to College of Life Sciences Human Tissue Governance Committee. SOP HTA-1004-UoL Version 2 July 2018 Page 4 of 5

5 7 Monitoring and Audit Criteria Key Performance Indicator All samples to be tracked and traced and records audited by local department. Method of Assessment Governance HTA Departmental audits. Frequency Annual HTA research governance audit Lead Governance Office This table is used to track the development and approval of the document and any changes made on revised / reviewed versions DEVELOPMENT AND APPROVAL RECORD FOR THIS DOCUMENT Author Tracey Edwards Job Title: HTA Governance Officer Reviewed College of Life Sciences Human Tissue Governance Committee by: Approved by: Designated Individual Professor Peter Bradding Date Approved: Date Issue Number Reviewed By July Diane Delahooke REVIEW RECORD Description Of Changes (If Any) Updated HTA Governance Officer to Governance Office, updated text to College of Life Sciences, correction of typographical errors. Change to DI. DISTRIBUTION RECORD: Date Name Dept Received SOP HTA-1004-UoL Version 2 July 2018 Page 5 of 5