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Published byLinda Coward Modified over 10 years ago
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“Gifting Tissue for Research: An NHS Organisational Challenge”
Jane Hair Deputy Director, NHS GGC Bio-repository
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Modern Tissue Banking Legal and Ethical Framework NHS GGC’s Policy and Procedures to help facilitate access.
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Modern Tissue Banking Not project specific Range of Sample Types: Snap Frozen, Formalin Fixed & Derivatives Fresh Clinical / Outcome data
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Gifting of Surplus Surgical Tissues A Vital Research Resource
Stand Alone Research Tissue Bank Pathology Archival Material
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New Legislation: Science, Society, and the Law
Restore public confidence in the scientific community Promoting the enormous benefits of human tissue research Protecting the rights of society and individuals better Refining our legislation to better provide support for science and the protection of the individual
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Human Tissue Act (2004) Consent Human Tissue Authority Regulation & Licensing of “approved purposes” 9 Codes of Practice
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Human Tissue Act (2004) Consent is a positive act Do not need to obtain consent personally but need to be confident of procedures and review them regularly Can be specific and / or general (‘broad and enduring’)
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Human Tissue Act 2004 (Consent Required)
Research on identifiable samples Storage
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Human Tissue Act 2004 ( No Consent Required)
Research on anonymous samples with REC approval Storage and use of “existing holdings” (pre Sept 2006)
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Human Tissue Act 2004 ( No Consent Required)
Living Persons Only Clinical audit Education or training related to health Performance assessment Public health monitoring Quality assurance
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Human Tissue (Scotland) Act (2006)
Consistent with legislation in England and Wales Based on ‘authorisation’ instead of ‘consent’ Health Improvement Scotland: Standards for Tissue Banks
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Ethical Principles Accountability: Transparency in Policy & Systems. Human Samples Treated as Gifts Rather Than Commodities. Traceability: Donor to Research End User Accessibility: Science – Led Fair Access Policy
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Ethical Review of Research Tissue Banks
National Research Ethics Service (NRES) Research Ethics Committees (REC)
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Why ethical review? Approval for specific research project without consent / authorisation Tissue Bank Status: This will allow for generic ethical approval to be given for research using banked tissue, addressing the ethical issues upfront without unnecessary repetition. Submission of annual report
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Issues for Ethical Review
Quality/content of informed consent / authorisation arrangements Arrangements for collection of tissue Information about prospective research purposes Feedback of clinically significant information Policy for researcher access to tissue, any exclusions Return of research data to link with banked samples
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The Practical Implications: Organisational Challenge for the NHS
Guardians of tissue and data Responsibility to ensure: governance structure, policies, systems and protocols NHSGGC largest HB in Scotland. Provide Health Care for more than a third of population in Scotland.
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Main Organisational Challenge Patient’s Authorisation Ensuring all patients have the opportunity to gift their surplus tissues
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Key Points to Establish
Patient Information. Who should seek authorisation When should patients be asked Where should be recoded
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First Point- How To Inform Patients
Information Develop one standard information sheet. A4 Comply with Health Board’s Equality & Diversity Standards Medical Records to issue with every appointment letter
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Who Asks the Question ? Research Nurse patients are extremely well informed very limited numbers stand alone consent form
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Who Asks the Question ? The Surgeon Recoded on the “consent to anaesthesia” form. Potential for increased number NHSGGC recent audit 5% patient have been asked.
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When Should Patients be Asked ?
Ward Prior to Surgery Lots of demands on patient Main focus on proposed surgery, risks, post surgical care
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Where Should Wishes be Recorded ?
Recorded on “Consent to Anaesthesia form”. Information then has to be manually transferred to “Pathology Request” form by theatre staff.
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NHSGGC System Redesign: Use of IT to enable process
Stand alone screen to record patient wishes and withdrawal: electronic – Surplus Tissue Authorisation Form (e-STA) Information held centrally in SCI store This information can be accessed by Pathology and Bio-repository to confirm patients wishes
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e- Surplus Tissue Authorisation (eSTA)
Audit of New Process 28
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Patient Pathway: Pre Operative Assessment (POA) Clinic
OP visit with Surgeon Surgery proposed & agreed OP visit with Surgeon Surgery proposed & agreed POA appointment letter posted PI included Patient referred directly to POA clinic or Patient attends POA clinic e-STA form completed PI given to patient by OP staff before leaving for POA clinic PI given to patient by POA staff on arrival at POA clinic. Patient attends POA clinic e-STA form completed
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Analysis of Raw Data: 783 patients
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97.4% Patients Who Gave Authorisation
Questions ? Reassurance that taking surplus tissue for research would not effect diagnosis and treatment Reassurance that no additional tissue would be taken
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1.8% Patients Who Did Not Give Authorisation
Patients do not need to provide a reason.
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1.8% Patients Who Were Undecided
Reasons Received PI at the POA clinic Needed more time to consider Wished to discuss with husband
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Patient’s Directly Contacting Bio-repository
2 Calls More Information: Patient had been under hospital care for some time and first time had received a PI. Wondered why. Patient wished to give authorisation before attending POA
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NHSGGC System Redesign
Patient Information Posters
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The Organisational Challenge
NHS R&D activity not immediate priority for staff at clinical “coal face”. “Who pays for the Patient Information Sheet”
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Tissue Banking Supporting Policy
“Better Cancer Care: An Action Plan” (2008) Gradual role out of e-STA Ayrshire & Arran & Lanarkshire, GJ National collections Renal (SCOTRRCC Study) Colorectal
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Gifting Tissues for Research A Vital Research Resource
Critical for research -molecular & genetic epidemiology -molecular pathology -pharmacogenetics Health Improvements / Stratified Medicine - better diagnostics, better drugs, better outcomes.
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