Presentation on theme: "Gifting Tissue for Research: An NHS Organisational Challenge Jane Hair Deputy Director, NHS GGC Bio-repository."— Presentation transcript:
Gifting Tissue for Research: An NHS Organisational Challenge Jane Hair Deputy Director, NHS GGC Bio-repository
Modern Tissue Banking Legal and Ethical Framework NHS GGCs Policy and Procedures to help facilitate access.
Modern Tissue Banking Not project specific Range of Sample Types: Snap Frozen, Formalin Fixed & Derivatives Fresh Clinical / Outcome data
Gifting of Surplus Surgical Tissues A Vital Research Resource Stand Alone Research Tissue Bank Pathology Archival Material
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
Human Tissue Act (2004) Consent Human Tissue Authority Regulation & Licensing of approved purposes 9 Codes of Practice
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)
Research on identifiable samples Storage Human Tissue Act 2004 (Consent Required)
Research on anonymous samples with REC approval Storage and use of existing holdings (pre Sept 2006) 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
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
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
National Research Ethics Service (NRES) Research Ethics Committees (REC) Ethical Review of Research Tissue Banks
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
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
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.
Main Organisational Challenge Patients Authorisation Ensuring all patients have the opportunity to gift their surplus tissues
Key Points to Establish Patient Information. Who should seek authorisation When should patients be asked Where should be recoded
First Point- How To Inform Patients Information Develop one standard information sheet. A4 Comply with Health Boards Equality & Diversity Standards Medical Records to issue with every appointment letter
Who Asks the Question ? Research Nurse patients are extremely well informed very limited numbers stand alone consent form
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.
When Should Patients be Asked ? Ward Prior to Surgery Lots of demands on patient Main focus on proposed surgery, risks, post surgical care
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.
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
e- Surplus Tissue Authorisation (eSTA) Audit of New Process
Patient Pathway: Pre Operative Assessment (POA) Clinic OP visit with Surgeon Surgery proposed & agreed POA appointment letter posted PI included Patient attends POA clinic e-STA form completed OP visit with Surgeon Surgery proposed & agreed Patient referred directly to POA clinic 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. or
Analysis of Raw Data: 783 patients
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
1.8% Patients Who Did Not Give Authorisation Patients do not need to provide a reason.
1.8% Patients Who Were Undecided Reasons Received PI at the POA clinic Needed more time to consider Wished to discuss with husband
Patients 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
NHSGGC System Redesign Patient Information Posters
The Organisational Challenge NHS R&D activity not immediate priority for staff at clinical coal face. Who pays for the Patient Information Sheet
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
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.