Storage of Human Tissue Samples - Central Manchester University ...

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3.1.1 Designated Individual (DI) - Accountable to the Human Tissue Authority for Research Tissue Stored under the authority of the Trust Licence and for making relevant Trust staff aware of this document. 3.1.2 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 Trust Licence. This includes making all staff that collect, store or use such tissue aware of this document. 3.1.3 All staff collecting, storing or using human tissue for research under the Trust Research Tissue Licence are accountable to the relevant PD(s) and the DI for undertaking work in compliance with this document. In compliance with the Research Licence issued by the HTA, CMFT expects all persons operating on the CMFT 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 Trust Wide and/ or local Standard Operating Procedures (SOPs). 4 Procedure 4.1 Premises, staff and safety 4.1.1 Access to the licensed premises/collection must be restricted to authorised persons to preserve the integrity of the collection and its records. 4.1.2 Storage sites (freezers etc) must be clearly labelled as containing human tissue samples being held under the HTA licence. 4.1.3 Equipment used for storage should be covered by an annual maintenance contract. As a minimum this should include -80 °C freezers and cryogenic storage tanks. 4.1.4 All staff handling human tissue must be appropriately trained. They will need to be aware of the risks of handling human tissue and measures in place to reduce any risk. 4.1.5 All staff handling human tissue should be immunised against Hepatitis B (and other infectious diseases as applicable) and their immune titre monitored at regular intervals by Occupational Health, as advised. 4.1.6 Laboratory attire e.g. lab coat and latex\nitrile gloves and other applicable protective wear, must always be worn when handling human tissue and specimen containers which hold human tissue. Care must be taken to examine specimen containers. Where there are problems e.g. with leakage or broken containers, these incidents must be logged as an adverse event or incident and follow-up action taken. 4.1.7 Storage and handling of tissue must be done in compliance with the Trust Health and Safety Policies available at: http://intranet.xcmmc.nhs.uk/directorates/depthumanres/HealthandSafety/ draft.asp HTA009 - Storage of human tissue samples (research). Page 4 of 8 See the Intranet for the latest version. Version Number:- 1: 02/10/2009
4.1.8 Adverse events must be reported directly to the DI or Human Tissue Project Manager. (See HTA SOP HTA012: Adverse event/incident reporting and Trust document RM002: Incident reporting policy). Adverse events and corrective action plans are discussed at HTA Persons Designated Meetings. 4.1.9 Risk assessments must be carried out for all processes covered by the licence. As a minimum this must include collection, handling, storage, transfer and disposal of relevant material. (Trust document RM003: Risk Identification and Analysis Policy). Risk assessments must be performed annually and are reviewed periodically by the DI or HT Project Manager. 4.1.10 All data should be recorded on an electronic system that is restricted and backed-up centrally. 4.2 HTA Master File Documentation 4.2.1 Any department / laboratory storing relevant material under the HTA Licence must maintain a HTA Master File. 4.2.2 Any department / laboratory intending to store material under the licence in the future (e.g. material for which ethics approval is due to expire) must prepare a HTA Mater File 6 months in advance. This is to enable the DI to assess the suitability of the laboratory prior to any material being stored and ensure compliance with the terms of the licence. 4.2.3 Contents of the HTA Master File are given in Appendix A. 4.2.4 The Human Tissue Project Manager will produce standard templates for data required and these will be controlled according to SOP HTA007: Human Tissue Act Document Control (Research). 5 Equality Impact Assessment 5.1 This document has been equality impact assessed by the author using the Trust’s Equality Impact Assessment (EqIA), which has been submitted to the Equality and Diversity Department for ‘Service Equality Team Sign Off’. 5.2 The EqIA score fell into low priority (0 – 9); no significant issues in relation to equality, diversity, gender, colour, race or religion are identified as raising a concern. 6 Consultation, Approval and Ratification Process 6.1 Consultation and Communication with Stakeholders 6.1.1 All Trust-wide Human Tissue Act documents are written by a member of staff with relevant expertise and experience. Additional advice is sought from members of the research community within the Trust or external advisors, as necessary. HTA009 - Storage of human tissue samples (research). Page 5 of 8 See the Intranet for the latest version. Version Number:- 1: 02/10/2009
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