The Human Tissue Act and YouSteve Hopkins

Designated Individual for Research Tissue

http://www.hope-academic.org.uk/irr/hta/

Aims

Brief introduction to the HTA To explain the role of the Designated

Individual, Licence Holder and Persons Designated

To summarise what is regulated To explain how this affects you

Review of the Law 2000-2004What Influenced this?

Bristol / Alder Hey / Isaacs Reports CMO recommendations - January 2001 Retained Organs Commission Consultation on review of the law

Human Tissue Act

The Human Tissue Act 2004 (HT Act) repeals and replaces the Human Tissue Act 1961, the Anatomy Act 1984 and the Human Organ Transplants Act 1989 as they relate to England and Wales, and the corresponding Orders in Northern Ireland.

Human Tissue Act

The HT Act makes consent the fundamental principle Storage and use of body parts, organs

and tissue from the living or deceased for specified purposes

Removal of material from the deceased

Two HTAs

Human Tissue Act (HT Act): Legislation underpinning lawful storage and use of tissue from the living or the deceased and removal of such material from the deceased.

Human Tissue Authority (HTA): Established to regulate activities under the Act

The Human Tissue Authority’s Regulatory Aim

To create an effective regulatory framework for the removal, retention, use and disposal of human tissue and organs in which the public and professionals have confidence

Licensed Sectors

Tissue for human application Post Mortem services Anatomy Public display Research

Licensing under the HT Act 2004

One activity per licence

A licence must specify the premises where the activity is to be carried out

A licence cannot authorise licensed activity on premises at different places

One person (Designated Individual) supervises the activities under a licence

HTA Governance Framework

Designated Individual

Licence applicant (if different to DI)

Person Designated: a person authorised by the DI and notified to the HTA, to whom the Licence applies

Persons acting under the direction of a DI or a Person Designated

HTA Governance Framework

Licence

The Role of the Designated Individual (DI)

Specific responsibilities as set out in section 18 of the Human Tissue Act

The DI is the person under whose supervision the licensed activity/ies are authorised to be carried on

Must be in a position to secure that activities are conducted properly by people who are suitable to carry out those activities

Person Designated

Person designated as a person to whom the licence applies Must be named in a notice given by the DI

to the Authority Other people can work under the direction

of this person

Licence Holder

Licence holder (if different to DI) Must have consent of DI for application Can be a corporate body: e.g. NHS Trust Can apply to vary licence to remove DI

without his/her consent

Human Tissue Act

The HT Act makes consent the fundamental principle Storage and use of body parts, organs

and tissue from the living or deceased for specified purposes

Removal of material from the deceased

Ethics and HTA

Human Tissue Act – Statutory

Ethical Approval – Is not

Research Tissue Storage: Does it Require a Licence?

Tissue removal Tissue removed and stored for the primary purpose of

diagnosis or treatment - No Licence Tissue removed and stored to determine the cause of

death – Post Mortem Licence

Tissue removed and stored for the primary purpose of research

A specific research project with ethical approval – No Licence

Distribution to other researchers (tissue bank) – Licence A possible project in the future – Licence

PRIMARY PURPOSE:Research

Yes, unless material is obtained

from a living person and is anonymised

Is it stored for a specific ethically

approved research project?

Yes No

Is a licence required?

Is a licence required?

Yes

Is consent required?

Yes

Is consent required?

No

Specific Ethically Approved Project

Is use of tissue if defined clearly within an ethically approved project

Is not research on a specified disease (e.g. ‘Research to prevent growth of brain tumours’) where the specific project (e.g. Evaluation of growth factor production by pituitary tumours) has not been clearly outlined

Is not research where the tissue collection is specified in an ethics application but the specific use is not.

Relevant Material

Consists of / includes cells – except gametes, embryos, hair or nails

Processed material, unless acellular

‘Waste products’, unless acellular

Isolated cells – except cell lines

NRES & TissueExamples from Applications

NRES & Tissue Examples from Applications

NRES & Tissue Examples from Applications

NRES & Tissue Examples from Applications

Ethically Approved Tissue Bank

Voluntary

2 Types

1) Ethical approval for storage

Or

2) Ethical approval for storage and use

Tissue Scenario 1

Ethically approved study collects blood from patient group

Store plasma for specified hormone measurement

Whole blood sample sent to another site for DNA extraction and storage

Keep remainder of plasma for later research without current approval

No Licence issue: blood may be an issue for the other site, if stored, but plasma is not regulated

Tissue Scenario 2

Ethically approved study collects blood from patient group

Store plasma for specified hormone measurement

DNA extracted immediately for storage and subsequent studies

Keep remainder of plasma for later research without current approval

No Licence issue: plasma and DNA storage are not regulated

Tissue Scenario 3

Skin samples collected from patients and volunteers for evaluation of structural proteins in and ethically approved study

Blood stored for later extraction of DNA to analyse genes for these proteins

No Licence issue: both tissues stored for specified research

Tissue Scenario 4

Muscle biopsies collected from patients for evaluation of defined muscle proteins for an ethically approved study of myaesthenia

Blood stored for later studies of the genetics of muscle disease

There is a Licence issue: the research use of the blood is not specifically defined

Tissue Scenario 5

Clinical trial collects blood and plasma samples for analysis of drug levels, defined metabolites and genes identifying susceptibility to the trial drug

Stored in trials unit to be sent to drug company at 3 month intervals

No Licence issue: the blood is stored for a specific research project

Tissue Scenario 6

Clinical trial collects blood and plasma and urine samples for analysis of drug levels, defined metabolites and to establish bank of tissue for future identification of drug targets.

Stored in trials unit to be sent to drug company at 3 month intervals

There is a Licence issue: blood is stored for more than 7 days before transport and not for a specific project

Tissue Scenario 7

Kidney biopsies collected for diagnosis and stored in the Histopathology Department

Ethically approved project requests release to a research group to analyse tubule proteins

No Licence issue: the tissue has been stored for diagnosisand the specific project is ethically approved

Tissue Scenario 8

Lung tissue collected by ethically approved tissue bank with authority to approve projects using tissue

Sends tissue for a research project at another site with no HTA Licence and no NRES/IRAS approval

There is a Licence issue but storage is under License(or the bank would not have been ethically approved) and can grant approval for subsequent projects

Tissue Scenario 9

Consent obtained from patients for storing tumours removed at surgery, for future research on brain tumours

No Ethical Approval applied for No current research study being

undertaken

What approvals needed?

An HTA Licence and approval of the DI

Designated Individual for Research TissueSteve Hopkins: Ext - 64269

http://www.hope-academic.org.uk/biomed/HumanTissue.htm