Standard Operating Procedure for the Use and Storage of Human Tissue for the purposes of Research and Teaching

Transcription

1 Standard Operating Procedure for the Use and Storage of Human Tissue for the purposes of Research and Teaching Version Number : 2 Review Date: September 2015 Authors: Lucy Ghali Graham Shennan Position Designated Individual Deputy Technical Manager Approved by: Celia Bell Head of Department Licence No: Page 1 of 10

2 CONTENTS 1. Background 2. Purpose 3. Responsible Personnel 4. Definitions 5. Procedure 5.1 Risk Assessments 5.2 Monitoring Risks 5.3 Contingency Planning 5.4 Adverse Events 6. References 7. Referenced SOPs 8. Contacts Appendix A Middlesex University HTA Risk Assessment Form Appendix B Middlesex University HTA Risk Assessment Guidance Notes 9. Declaration Page 2 of 10

3 1. Background The Human Tissue Act 2004 (HT Act 2004) is a framework for regulating the storage and use of human organs and tissue from the living, and the removal, storage and use of tissue and organs from the deceased, for specified health-related purposes including medical research. The HT Act 2004 replaces the Human Tissue Act 1961, the Anatomy Act 1984 and the Human Organ Transplants Act The Human Tissue Act 2004 (HT Act 2004) is applicable in full to England, Wales and Northern Ireland; there is a separate legislation for Scotland. The Act was fully implemented on 1st September The HT Act set up the Human Tissue Authority (HTA) which issues licences for a number of licensable activities under the HT Act. Middlesex University is the Licence Holder for Research, Education and Training. To comply with the conditions of the Licence the University is required to ensure that risk assessments of practices and processes in relation to licensable activities are completed regularly, and that the assessments are recorded and monitored appropriately by trained staff. 2. Purpose The purpose of this Standard Operating Procedure (SOP) is to set out the processes and procedures for carrying out a HTA Risk Assessment for damage to / loss of human tissue, including risk monitoring and contingency planning. (NB there is a parallel system for health and safety risk assessment of laboratory procedures. The LabRAT form (downloadable from the Lab Wiki) is for risk assessing all laboratory activities and establishing suitable controls to protect all staff, students and others who may be exposed. This Lab RAT must be completed by the relevant lab-person before the activity is undertaken and, where appropriate, considered and endorsed by the relevant supervisor. 3. Responsible personnel This HTA SOP applies to all Middlesex University staff and students who are responsible for collecting, using or storing human tissue for research or teaching purposes. It also applies to employees of other organisations holding relevant material under the Middlesex University HTA Licence. This SOP must be used in conjunction with the Human Tissue Authority Codes of Practice and all other relevant University and, where appropriate, local University Health and Safety policies and SOPs. Page 3 of 10

4 All staff involved with the transportation, use, storage or disposal of human tissue must be aware of the potential risks to the tissue. A copy of the risk assessment must be given to every individual carrying out the activity and each copy must be countersigned by the holder. Middlesex University HTA Governance Team is responsible for ensuring that the SOP remains fit for purpose. 4. Definitions Human Tissue Authority (HTA) The governing body set up to regulate activities that come under the HT Act. The HTA is a watchdog that supports public confidence by licensing organisations that store and use human tissue for scheduled purposes. HTA Risk Assessment (HTA-RA) A risk assessment conducted specifically for reviewing all aspects involved in the collection, testing, processing, storage and distribution of human tissue and cells that might lead to loss or damage of such material and specifying all controls that may be necessary to minimise / ameliorate such loss or damage. Human Tissue Any and all constituent parts of the human body formed by cells. Relevant Material Any material, other than gametes, removed from the body which consists of or includes human cells. In the HT Act references to relevant material from a human body do not include: embryos outside the human body, hair and nail from the body of a living person, cell lines or any other human material created outside the human body, serum, plasma, DNA and RNA, See the Human Tissue Authority website1 for the HTA Supplementary List of Materials (appendix A). HTA Designated Individual (DI) The lead person who is authorised and who supervises activities under a licence issued by the Human Tissue Authority. Please refer to the Contacts list for the name of the current DI. Page 4 of 10

5 HTA Person Designate (PD) A person to whom the licence applies and to whom the authority conferred by the licence extends. Each School operating under an HTA Licence should have at least one Person Designate. The activity of each PD is overseen by a senior PD and the DI. Please refer to the Contacts list for the name of the current PDs and senior PDs. HTA Principal Investigator (PI) is the appropriately qualified individual for each project who has responsibility for the conduct of projects under their control. The activity of each PI is overseen by a PD HTA Licence Holder (LH) Nominally this is Middlesex University but represented by a named individual. Please refer to the Contacts list for the name of the current LH. Standard Operating Procedure (SOP) Detailed, written instructions to achieve uniformity of performance of a specific function 5. Procedures Risk management is a process to measure and assess risk and specify appropriate controls to minimise risks through the use of risk assessments, risk monitoring and contingency planning. This SOP considers the risks to the usability of human tissue as might arise from fridge/freezer failure or damage during transport / theft, misplacement or unauthorised use / or from documentation failure or mislabelling. A risk assessment must be completed by the PI for each practice and process involving human tissue, including transportation, use, storage and disposal, before the activity begins. The completed risk assessment must be made available to all relevant persons to read and understand and should form part of the internal audit procedure. For risk assessment form and guidance notes see Appendix A and B respectively. Record Keeping A copy of the risk assessment must be given to every individual carrying out the activity and each copy must be countersigned by the holder. The PI must keep records of all risk assessments, updates and countersigned distributions. See the Middlesex University HTA Standard Operating Procedure for the Management of Records. Page 5 of 10

6 Reviewing HTA Risk Assessments All completed HTA risk assessments must be reviewed annually and old copies must be replaced with new ones (if there are no changes, the form should record the date of review and that no amendments required). If any serious adverse event occurs, the risk assessment must be revisited and reassessed as soon as possible and required measures / controls incorporated, to reduce any further potential hazards. Relevant staff must be notified and must countersign and follow the updated version. Monitoring Risks and Contingency Planning This SOP outlines how risks can be identified and contingency plan will be drone up when significant risks deem it necessary. Records of samples receipt, storage, use and disposal will be audited on regular basis and records will be updated. PDs and PIs will audit these records on biannual basis. Tissue holdings including tissue transferred on/off site. Storage conditions of freezers will be electronically monitored and recorded. Other storage facilities will be periodically assessed for its suitability. Adverse events will be reported, monitored and addressed as below. HTA Adverse Events Any adverse events involving human tissue must be reported to Middlesex University Designated Individual and to the Person Designate in charge immediately. The Middlesex University Adverse Event SOP must be followed and the form must be completed. Following an HTA Adverse Event, the relevant risk assessments must be reviewed and updated accordingly and as soon as possible. Page 6 of 10

7 Human Tissue Risk Assessment Form School / Building: Department: Version No: 1 Name of Assessor: Room No: Date: Brief Description of Procedure/Activity and its Location (Please include details of samples, associated risks, activities and location and equipments to be used) Page 7 of 10

8 Risks to Human Tissue Samples Risk to HTA Samples Persons Risk Controls Risk Rating Future Requirements affected (outline the controls in place) Severity (1-3) Likelihood Risk Acce Y/ N (with timescales) Page 8 of 10

9 Date of Name of Reviewer Review: Date of Next Review Signature: 8. Contacts LH Middlesex University represented by Jan Williams DI Lucy Ghali Lead PDs Hemda Garelick Frank Hills Lygeri Demetriou Health & Safety Graham Shennan Page 9 of 10

10 9. Declaration I have read and understood fully Middlesex the University HTA Standard Operating Procedure for Risk Management and Contingency Planning and agree to follow the procedures laid out in this document. Print Name Sign Name Date Page 10 of 10