Procedure For Training In Use Of Human Tissue Obtained For Research Purposes

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1 Reference Number: UHB 137 Version Number: 2 Date of Next Review: 11 TH Oct 2019 Previous Trust/LHB Reference Number: Procedure For Training In Use Introduction and Aim The Human Tissue Act 2004 (HT Act) came fully in to force on 1 September The aim of the HT Act is to provide a legal framework regulating the storage and use of human tissue from the living and the removal storage and use of tissue from the deceased. It introduces regulation of other activities like post mortem examinations, and the storage of human material for education, training and research. It is intended to achieve a balance between the rights and expectations of individuals and families, and broader considerations, such as the importance of research, education, training, pathology and public health surveillance to the population as a whole. Cardiff and Vale University Health Board (the UHB), accepts its responsibility under the Human Tissue Act 2004 and the Codes of Practice of the Human Tissue Authority (HTA) to comply with the standards and guidance. This document supports the Human Tissue In Clinical Research Management Policy UHB 097. The purpose of this Standard Operating Procedure (SOP) is to ensure that all staff involved in human tissue activities (both current and new) who are acting under the licence are fully aware of the UHB s induction, training and development system and of the required training that must be completed to ensure compliance with the HTA legislation and Codes of Practice. Objectives Adherence to this procedure will ensure that a level of quality is achieved through adoption of a system of procedures that reflect the regulatory standards and guidelines and underpin this procedure. This procedure has been developed to ensure: That all individuals involved in undertaking clinical research involving human tissue within the UHB, are aware of the requirements of the Human Tissue Act 2004 and the relevant Codes of Practice set by the Human Tissue Authority. all staff who work with human tissue in a clinical research environment understand their individual responsibilities for the quality of their work which should result in a continually improving working environment for all training will be provided to support this policy. A level of quality is achieved and maintained which enhances the UHB s reputation with stakeholders. Scope This procedure applies to all of our staff in all locations including those with honorary contracts. Equality and Health An Equality and Health Impact Assessment (EHIA) has not

2 Document Title: Procedure For Training In Use 2 of 6 Approval Date: 11 th Oct 2016 Impact Assessment Documents to read alongside this Procedure Approved by been completed as this procedure supports the Human Tissue In Clinical Research Management Policy UHB 097. An EQIA was completed for this policy and, we found no evidence of any impact since the policy is consistent and applies to everyone involved in research involving human tissue, within Cardiff and Vale University Health Board and the policy is consistent with those in other NHS organisations. Human Tissue In Clinical Research Management Policy UHB 097 Human Tissue Authority Code of Practice 9- Research. Good Clinical Practice For Personnel Undertaking Clinical Research Policy Conducting Personal Appraisal Development Reviews (PADRs) Policy (UHB079) Research Governance Group Accountable Executive or Clinical Board Director Medical Director Author(s) Research Governance Officer Human Tissue Disclaimer If the review date of this document has passed please ensure that the version you are using is the most up to date either by contacting the document author or the Governance Directorate. Summary of reviews/amendments Version Number Date of Review Approved Date Published Summary of Amendments 2 11/10/16 18/10/2016 Revised document. Updated to new UHB format and incorporate new titles 1. PROCEDURE

3 Document Title: Procedure For Training In Use 3 of 6 Approval Date: 11 th Oct 2016 Identification of Training Needs The NHS Knowledge Skills Framework (KSF) and associated Personal Appraisal Development Review (PADR) lie at the core of the career and pay progression strand of Agenda for Change. The KSF is designed to provide a consistent and comprehensive framework of NHS-wide knowledge and skills on which to base the development planning and review of all staff. It defines the knowledge and skills which NHS staff need to apply in their work in order to deliver quality services. It provides a single, consistent, comprehensive and explicit framework on which to base review and development of staff. Who Requires Training? Designated Individual - The DI is required to complete accredited training provided by the HTA. This is available as an e-learning package or in a face-to-face setting. Person Designated - The PD must be fully compliant with the HT Act and the terms of the HTA Licence. It is therefore essential that the PD is familiar with the human tissue legislation and all Codes of Practice. NB this role is sometimes referred to as Human Tissue Officer for Cardiff University employees Staff -The UHB s Induction policy is designed to ensure that all new members of staff are provided with the necessary information and support to aid the smooth transition into their role. Training will be identified and discussed at the initial and ongoing meetings with the line manager/pi and staff training developed in line with the UHB Conducting Personal Appraisal Development Reviews (PADRs) Policy. Before any work involving human tissue is undertaken, new staff involved in HTA activities must have HTA training. Medical & Dental Staff - Separate procedures apply in respect of the reviewing of Medical and Dental staff but it is expected that all staff using human tissue for research purposes will be trained and be familiar with the human tissue legislation and relevant Codes of Practice and records of training kept. Methods of Delivering Training There are several ways in which training can be delivered; with all methods a record of the successful completion will need to be recorded in the personal development plan. Self Taught - Staff can self teach so they are familiar with HTA legislation and to ensure compliance with the HT Act. Self teaching can cover online courses and reading relevant documents. A list of useful web pages is available in the reference section. Records of completion of on-line courses should be kept by the relevant PD; any additional reading should be signed off by the PI.

4 Document Title: Procedure For Training In Use 4 of 6 Approval Date: 11 th Oct 2016 School/Unit/Local Training - Individual Schools/Units may organise their own local training sessions each year or as and when required, to distribute all current and new information that staff and students need to be familiar with. These sessions can be co-ordinated and delivered by the relevant school PD or by the HTA Co-ordinator. An attendance list should be kept by the relevant school PD. Central Training - the HTA Co-ordinators for the University & the UHB run an introductory course on the use of human tissue and ad hoc HTA awareness raising sessions are also provided. External Training - This can be provided where necessary and is usually identified during the probation or appraisal process. HTA and Consent Training All staff involved in human tissue activities should undertake training on the HTA legislation including training on informed consent. This is to ensure that all staff have the necessary knowledge and skills to carry out their roles and responsibilities in compliance with the HT Act and HTA Codes of Practice. Training covering HTA and the process of taking consent (see Good Clinical Practice below) can be found at the following locations: UHB and Cardiff University, lunchtime training programme UHB EIDO consent module, available on the clinical portal; Medical Research Council e-learning Research and Human Tissue Legislation ; HTA e-learning for Designated Individuals. General Training It is recommended that staff and, if applicable, students have the following essential skills and knowledge as may be necessary to ensure that they are equipped to perform their role. This list of general training below is intended to be indicative and not exhaustive: Health and Safety training Research Governance procedures Adverse Event/ incident Reporting Record Management and Archiving Risk assessment and management of risk Data Protection and Confidentiality Awareness of Material Transfer Agreements (MTA) and contracts Research Ethics Good Clinical Practice (GCP) training Record Keeping All staff should maintain an up-to-date training log. A record of all training should be kept locally and a copy sent to the relevant PD. All certificates

5 Document Title: Procedure For Training In Use 5 of 6 Approval Date: 11 th Oct 2016 issued following successful completion of on-line courses should be kept as proof of course completion. 2 RESOURCES The policy of the UHB is to ensure that all personnel are trained and experienced to the extent necessary to undertake their assigned activities and responsibilities effectively. This procedure provides a framework for training for the use of tissue in research. 3 TRAINING Line managers are responsible for identifying and making recommendations on the training needs of their staff and for ensuring that all employees allocated specific tasks are suitably qualified and experienced to execute those tasks. Full records should be maintained of all training undertaken by employees. The existence of the Procedure and its implications for researchers will be covered during UHB Research and Development training events e.g. Good Clinical Practice Training Day, Getting Started in Research Study Day, Senior Medical Staff Induction. Ongoing appropriate support of research staff will be provided via the UHB Research and Development Department.

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