1. “Gifting Tissue for Research: An NHS Organisational Challenge”
Jane Hair
Deputy Director, NHS GGC Bio-repository

2. Modern Tissue Banking
Legal and Ethical Framework
NHS GGC’s Policy and Procedures to help facilitate access.

3. Modern Tissue Banking
Not project specific
Range of Sample Types: Snap Frozen, Formalin Fixed & Derivatives Fresh
Clinical / Outcome data

4. Gifting of Surplus Surgical Tissues A Vital Research Resource
Stand Alone Research Tissue Bank
Pathology Archival Material

5. 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

6. Human Tissue Act (2004)
Consent
Human Tissue Authority
Regulation & Licensing of “approved purposes”
9 Codes of Practice

7. 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’)

8. Human Tissue Act 2004 (Consent Required)
Research on identifiable samples
Storage

9. Human Tissue Act 2004 ( No Consent Required)
Research on anonymous samples with REC approval
Storage and use of “existing holdings” (pre Sept 2006)

10. 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

11. 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

12. 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

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 / 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

15. 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

16. 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.

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 authorisation
When should patients be asked
Where 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

21. Who Asks the Question ?
Research Nurse patients are extremely well informed very limited numbers stand alone consent form

22. 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.

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 Process 28

29. 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

30. Analysis of Raw Data: 783 patients

31. 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

32. 1.8% Patients Who Did Not Give Authorisation
Patients do not need to provide a reason.

33. 1.8% Patients Who Were Undecided
Reasons
Received PI at the POA clinic
Needed more time to consider
Wished to discuss with husband

34. 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

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-STA
Ayrshire & Arran & Lanarkshire, GJ
National collections
Renal (SCOTRRCC Study)
Colorectal

38. 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.