Governance & Compliance Audit Of Human Tissue For Research Purposes Procedure

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1 Version Number: 2 Date of Next Review: 11 TH Oct 2019 Previous Trust/LHB N/A Governance & Compliance Audit Of Human Tissue For Research Purposes Procedure 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. The purpose of this Standard Operating Procedure (SOP) is to set out the procedure for the UHB, who, together with Cardiff University s Governance and Compliance Division and a PD (also known as Human Tissue Officer), will be conducting a governance and compliance audit. 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 activities related to human tissue, including consent, transportation, storage and disposal are conducted in accordance with the HTA Codes of Practice and that internal systems for compliance are effectively in place. Objectives The objectives of the internal audit are to ensure that: Appropriate and valid consent has been taken (or a legitimate consent exemption applies) and that the material is being used in accordance with the consent Appropriate governance arrangements are in place for the collection, use, storage and disposal or future use of the material The premises and equipment used for the storage of relevant material is compliant with HTA guidance and requirements Appropriate disposal methods are being used and full records are kept Essential documentation relating to all aspects of the relevant material is held by the Chief/Principal Investigator (CI/PI) SOPs are being followed during the handling/processing of material An audit trail is in place from receipt of sample to disposal The CI/PI and all other staff involved with the samples have received HTA training and, if relevant, consent training Scope

2 2 of 5 Approval Date: 11 Oct 2016 This procedure applies to all of our staff in all locations including those with honorary contracts holding relevant material under the Cardiff University HTA Licence.. Equality and Health An Equality and Health Impact Assessment (EHIA) has not Impact Assessment 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 Documents to read alongside this Procedure Approved by 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 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 3 of 5 Approval Date: 11 Oct 2016 Governance and compliance audits of research projects are undertaken to confirm that the area concerned is adhering to the UHB s Procedures and is compliant with HTA requirements and regulations. Face to Face Audit The face to face audit schedule comprises a records audit, to ensure records are accurate, complete and legible; a process audit to ensure staff are adhering to SOPs; and a traceability audit to ensure that the establishment can trace specimens from donors consent, or point of receipt if supplied by a third party, to storage, use or disposal. Prior to the governance and compliance face-to-face audit, the HTA Coordinator will: check documentation at the Research and Development Office to ensure familiarity with the project and identify if anything is missing; review any local SOPs that should be followed during the process audit; identify a selection of projects for which compliance will be audited including samples stored under the university licence and a random sample of those stored under NRES approval; if applicable, review report of the last visit and look at recent telephone/ conversations; check availability of PD and School/Unit to be inspected and also a PD from another school; schedule a visit stating time, date, venue, expected duration of visit and outlining purpose of visit, items for discussion, which samples will be looked at, any storage facilities that will want to be seen and if any other personnel including the PI s need to be present; send confirmation of this to PD and those who are being audited; send the HTA Audit Checklist to PD and those who are being audited so that staff are fully aware of what will be covered; gather documentation needed for visit- including own audit checklist. During the visit the HTA Co-ordinator and PD will: review site file of documentation as set out in the HTA Audit Checklist; work through the HTA Audit Checklist of documentation to establish what is held and where there are gaps that could be filled; discuss adverse event reporting system and any adverse events that have occurred, including remedial action taken; inspect storage facilities;

4 4 of 5 Approval Date: 11 Oct 2016 ask a member of staff to demonstrate how the tissue is handled/processed, ensuring that all relevant SOPs are followed; conduct a trial of traceability system/record keeping to ensure that tissue samples can be traced from receipt to disposal and vice versa; discuss training needs; interview the PI if necessary to establish: whether staff involved in human tissue activities have the appropriate experience and training and whether they are familiar with HT Act and HTA Codes of Practice; if informed consent procedures are followed and records held; the record management and retention process; whether risk assessments have been carried out; if there are any issues/ queries that they would like guidance on. have a final meeting to discuss findings of audit. Following the audit, the HTA Co-ordinator will: complete the Audit Report within one week of the audit visit and send a copy to the PD; provide follow up information and suggest a timescale for implementation of any recommendations arising from the audit visit. 7.2 Paper Based Audit: Once a School/Unit has had a face to face audit, the second year can be a done via a paper based audit return. The procedure will be as follows: the HTA Co-ordinator will contact the Department/ Unit to inform them that a paper based inspection is required; the HTA Co-ordinator will send the HTA Audit Checklist to the School PD to be completed; the School PD will fill in the Audit Checklist and send it back to the HTA-Coordinator. This may involve individual units within the School providing specific information in relation to their unit; the School PD should report specifically on implementation of any recommendations made in the previous inspection visit; the HTA Co-ordinator and the PD will meet to discuss the paper based audit return. If there are any issues arising from the return that cannot be resolved otherwise, a face to face audit will take place; the face to face audit will take the same format as above.

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