Presentation on theme: "“Gifting Tissue for Research: An NHS Organisational Challenge”"— Presentation transcript:
1 “Gifting Tissue for Research: An NHS Organisational Challenge” Jane HairDeputy Director, NHS GGC Bio-repository
2 Modern Tissue BankingLegal and Ethical FrameworkNHS GGC’s Policy and Procedures to help facilitate access.
3 Modern Tissue BankingNot project specificRange of Sample Types: Snap Frozen, Formalin Fixed & Derivatives FreshClinical / Outcome data
4 Gifting of Surplus Surgical Tissues A Vital Research Resource Stand Alone Research Tissue BankPathology Archival Material
5 New Legislation: Science, Society, and the Law Restore public confidence in the scientific communityPromoting the enormous benefits of human tissue researchProtecting the rights of society and individuals betterRefining our legislation to better provide support for science and the protection of the individual
6 Human Tissue Act (2004)ConsentHuman Tissue AuthorityRegulation & Licensing of “approved purposes”9 Codes of Practice
7 Human Tissue Act (2004)Consent is a positive actDo not need to obtain consent personally but need to be confident of procedures and review them regularlyCan be specific and / or general (‘broad and enduring’)
8 Human Tissue Act 2004 (Consent Required) Research on identifiable samplesStorage
9 Human Tissue Act 2004 ( No Consent Required) Research on anonymous samples with REC approvalStorage and use of “existing holdings” (pre Sept 2006)
10 Human Tissue Act 2004 ( No Consent Required) Living Persons OnlyClinical auditEducation or training related to healthPerformance assessmentPublic health monitoringQuality assurance
11 Human Tissue (Scotland) Act (2006) Consistent with legislation in England and WalesBased on ‘authorisation’ instead of ‘consent’Health Improvement Scotland: Standards for Tissue Banks
12 Ethical PrinciplesAccountability: Transparency in Policy & Systems. Human Samples Treated as Gifts Rather Than Commodities.Traceability: Donor to Research End UserAccessibility: Science – Led Fair Access Policy
13 Ethical Review of Research Tissue Banks National Research Ethics Service (NRES)Research Ethics Committees (REC)
14 Why ethical review?Approval for specific research project without consent / authorisationTissue 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
15 Issues for Ethical Review Quality/content of informed consent / authorisation arrangementsArrangements for collection of tissueInformation about prospective research purposesFeedback of clinically significant informationPolicy for researcher access to tissue, any exclusionsReturn of research data to link with banked samples
16 The Practical Implications: Organisational Challenge for the NHS Guardians of tissue and dataResponsibility to ensure: governance structure, policies, systems and protocolsNHSGGC largest HB in Scotland. Provide Health Care for more than a third of population in Scotland.
17 Main Organisational Challenge Patient’s Authorisation Ensuring all patients have the opportunity to gift their surplus tissues
18 Key Points to Establish Patient Information.Who should seek authorisationWhen should patients be askedWhere should be recoded
19 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
24 When Should Patients be Asked ? Ward Prior to Surgery Lots of demands on patient Main focus on proposed surgery, risks, post surgical care
25 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.
26 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
28 e- Surplus Tissue Authorisation (eSTA) Audit of New Process28
29 Patient Pathway: Pre Operative Assessment (POA) Clinic OP visit with SurgeonSurgery proposed & agreedOP visit with SurgeonSurgery proposed & agreedPOA appointment letter postedPI includedPatient referred directly to POA clinicorPatient attends POA clinice-STA form completedPI given to patient by OP staff before leaving for POA clinicPI given to patient by POA staff on arrival at POA clinic.Patient attends POA clinice-STA form completed
31 97.4% Patients Who Gave Authorisation Questions ?Reassurance that taking surplus tissue for research would not effect diagnosis and treatmentReassurance that no additional tissue would be taken
32 1.8% Patients Who Did Not Give Authorisation Patients do not need to provide a reason.
33 1.8% Patients Who Were Undecided ReasonsReceived PI at the POA clinicNeeded more time to considerWished to discuss with husband
34 Patient’s Directly Contacting Bio-repository 2 CallsMore 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
35 NHSGGC System Redesign Patient Information Posters
36 The Organisational Challenge NHS R&D activity not immediate priority for staff at clinical “coal face”.“Who pays for the Patient Information Sheet”
37 Tissue Banking Supporting Policy “Better Cancer Care: An Action Plan” (2008)Gradual role out of e-STAAyrshire & Arran & Lanarkshire, GJNational collectionsRenal (SCOTRRCC Study)Colorectal
38 Gifting Tissues for Research A Vital Research Resource Critical for research -molecular & genetic epidemiology -molecular pathology -pharmacogeneticsHealth Improvements / Stratified Medicine - better diagnostics, better drugs, better outcomes.