“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.