gifting tissue for research: an nhs organisational challenge jane hair deputy director, nhs ggc...
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“Gifting Tissue for Research: An NHS Organisational Challenge”
Jane Hair
Deputy Director, NHS GGC Bio-repository
• Modern Tissue Banking
• Legal and Ethical Framework
• NHS GGC’s 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)
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 Patient’s 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
• InformationDevelop one standard information sheet. A4
Comply with Health Board’s Equality & Diversity Standards
Medical Records to issue with every appointment letter
Who Asks the Question ?
• Research Nursepatients are extremely well informedvery limited numbersstand alone consent form
Who Asks the Question ?
• The SurgeonRecoded 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 SurgeryLots 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 storeThis 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 SurgeonSurgery proposed & agreed
POA appointment letter postedPI included
Patient attends POA clinice-STA form completed
OP visit with SurgeonSurgery proposed & agreed
Patient referred directly to POA clinic
Patient attends POA clinice-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
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
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.