HTA and Biobank Lecture PDF
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This lecture covers the Human Tissue Act (HTA) and biobanks. It details tissue retention regulation, relevant material types, and ethical considerations for research involving human tissue. It also highlights HTA compliance and governance issues.
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Using Human Tissue In Research & MCRC Biobank Jane Rogan:- MCRC Biobank Business Manager & HTA DI for Research Introduction Tissue retention regulation Lax before the late nineties Alder Hey Organ Retention Scandal Bristol Royal Infirmary Hearts Scandal Decreased public confidence in resea...
Using Human Tissue In Research & MCRC Biobank Jane Rogan:- MCRC Biobank Business Manager & HTA DI for Research Introduction Tissue retention regulation Lax before the late nineties Alder Hey Organ Retention Scandal Bristol Royal Infirmary Hearts Scandal Decreased public confidence in research Human Implemented 01/09/2006 Tissue Removal, storage and use of Act human tissue Makes consent a fundamental 2004 principle Scheduled purposes Regulated by the Human Tissue Authority Licences DIs and PDs Inspections Defined by the HT Act as material other than gametes, which consists of, or includes, human cells. In the HT Act, references to relevant material from a human body do not include: (a) embryos outside the human body, or Relevant (b) hair and nail from the body of a living person. material Not limited in number of cells Relevant material or not? Fresh tissue Sections on slides Cultured cells Serum Urine DNA Saliva Types of Relevant Material Specifically Processed Bodily waste Cell deposits and Xenografts: identified material: products: tissue sections on relevant material If the intention is to Sometimes difficult to slides: Yes as intended to be or As long as primary cells collect plasma or serum categorise. represent whole cells are present in some form, (which is considered non the specimen will be relevant material) even classed as relevant though a whole blood material. sample is collected first a Most xenografts are no researcher can assume longer considered “normal expectations” primary human material can be exercised that the relevant to the act at the sample will be spun down end of passage 1 within 5 days Licences Held Storage of tissue samples for research purposes Storage of tissue samples from post- mortem examinations Storage of tissue samples for human transplantation Managing Governance The Christie Human Tissue Licence for Research The Christie Paterson Building MCRC Building Biobank Coordinat or Managin g Biobank Bioban Persons Designated Quality Manager k Governa Busine ss nce Human Tissue Manag er (Continu Coordinat or Designated Individual ed) Human Tissue Coordinat or Ethics Approval All research using Ethics approval is samples from NHS project-specific or a patients must have ‘research tissue bank’. ethics approval. Previous ‘generic’ Project specific ethics ethics approvals approval relates to acting as ‘tissue one protocol with banks’ are no longer defined endpoints. permitted. HTA Compliance Regulates “scheduled purpose” use and storage of human tissue. Not covered by a current recognised ethics approval Trust systems ensure HTA compliance once ethics approvals expire All research tissue banks Imported Material HTA Compliance (Continued) CONSENT GOVERNANCE PREMISES, TRACEABILITY AND QUALITY FACILITIES AND SYSTEMS EQUIPMENT The Trust has the responsibility to demonstrate compliance with these standards upon inspection by the Discussion Point Is consent always required to use tissue for research? Existing holdings If you have any samples collected for research before the HT Act came into play (1st September 2006), they are classed as existing holdings and they are exempt from the consent stipulations of the Human Tissue Act. Existing holdings may be used The research is ethically approved for research without consent as There is no potential harm to the donor long as: Appropriate cataloguing Stored directly under the license: Appropriate storage Discussion Point Do you think the HT Act damages medical research? Manchester Cancer “Making quality tissue collection Research Centre Biobank and retrieval easy for the researcher” Governan ce & Legislati on Established in 3 NHS Trusts 2007 Logistics Sample Quality Informati cs Blood Solid tumours disorders Efficient Access Structure and Partners Building a Successful Biobank Regulatory Logistics Quality Informatics Framework HTA Licence Biobank Technician Role Oversee whole process Sample Tracking System Research Tissue Bank Histology Facility SOPs for all aspects – STARLIMS Ethics “Buy-in” from Trusts Assess quality of Barcoding Samples Robust Consent Process Surgeons & Pathologists samples Standardising Data Section 251 Support Collection Discussion point Biobank Information Sheets and Consent Forms Sample Acquisition Sample collection over 15+ years Comprehensive Biobank across all tumour types Linked clinical data – sample and patient level Haematologi Solid Tumour Arm MCRC Biobank Overview cal Malignancy Arm FFPE Tumour & Patients Recruited: Blood Bone Normal Frozen 100 QC/Method Development Active Projects by Project Type Projects Slide Collection and 1 Scanning Banked Samples >25 Block Requests 1 Prospective Collection Secondary Biobank Projects Mixed 4 Mixed Block Requests Prospective Collection 26 Slide Collection and Scanning ~60 Banked Samples 26 Active projects 0 5 10 15 20 25 30 >90 Supported publications Managing Complexity Weekly plan but Multiple workflows Work with IPU/Daily changes daily Communication– Differing processing Call Multiple projects Huddles/Whatsapp/Teams requirements Competition for Project specific Haematological samples criteria samples Use of – PBMCs Microsoft Fresh delivery across 365 Tools to plan Competition for Fresh workload requirements in real time delivery across the UK samples the UK Fresh delivery across Information is key– project summary the UK Surgical sheets / priority lists – update in real Bloods time Drain Fluids Collections Sharing samples with multiple projects – large tumours Review of path Identifying Clear prioritisation suitable – responsive reports - suitable decision making samples samples Frozen sample Pulling slides and shipping worldwide blocks Pathology involvement and input External sample requests Sectioning of Logistics for supply samples Banked FFPE SlideSamples scanning Samples SECONDARY BIOBANKING Sample Sample CAPRA LOCALLY LEAD Storage Collection HYPROG EXTERNALLY 100,000 Genomes EN Project STAMPED CRUK E LEAD Stratified Labelling TARGET Block Medicine and CUP- Program requests COMP me tracking PM – SCT TRACER AMMO X Processin g Key Success Drivers ESTABLISHED EXCELLENT ROBUST PROVEN RESEARCH NETWORK CLINICAL GOVERNAN TRACK NEEDS MODEL WITH ENGAGEME CE RECORD OF DRIVE THE EXISTING INFRASTRUCT NT ACROSS FRAMEWOR PROVIDING SAMPLE URE AND ALL K FOR QUALITY COLLECTIO PATHWAYS CANCER TISSUE SAMPLES N, NOT THE FOR SAMPLE DISEASE AND DATA OTHER WAY COLLECTION TYPES ROUND THANK YOU