the human tissue act and you steve hopkins designated individual for research tissue

The Human Tissue Act The Human Tissue Act and Youand YouSteve HopkinsSteve Hopkins

Designated Individual for Research TissueDesignated Individual for Research Tissue

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

Aims Aims

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

Individual, Licence Holder and Persons Individual, Licence Holder and Persons DesignatedDesignated

To summarise what is regulatedTo summarise what is regulated To explain how this affects youTo explain how this affects you

Review of the Law 2000-2004 Review of the Law 2000-2004

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

Human Tissue ActHuman Tissue Act

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

Human Tissue Act Human Tissue Act

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

and tissue from the living or deceased and tissue from the living or deceased for specified purposesfor specified purposes

Removal of material from the Removal of material from the deceaseddeceased

Two HTAsTwo HTAs

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

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

The HTA’s Regulatory AimThe HTA’s Regulatory Aim

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

Licensed SectorsLicensed Sectors

Tissue for human application Tissue for human application Post Mortem servicesPost Mortem services AnatomyAnatomy Public displayPublic display ResearchResearch

Licensing under the HT Act Licensing under the HT Act 20042004

One activity per licenceOne activity per licence

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

A licence cannot authorise licensed activity on A licence cannot authorise licensed activity on premises at different placespremises at different places

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

HTA Governance FrameworkHTA Governance Framework

Designated IndividualDesignated Individual

Licence applicant (if different to DI)Licence applicant (if different to DI)

Person Designated: a person to whom the Person Designated: a person to whom the Licence appliesLicence applies

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

HTA Governance FrameworkHTA Governance Framework

DI

Persons Designated

Persons working under the licence

Persons working under the licence

Licence

Licence HolderLicence Holder

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

without his/her consent without his/her consent

The Role of the Designated The Role of the Designated Individual (DI)Individual (DI)

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

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

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

Person DesignatedPerson Designated

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

to the Authorityto the Authority Other people can work under the Other people can work under the directiondirection

of this personof this person

GovernanceGovernance

Persons acting under the direction of a DI Persons acting under the direction of a DI or Person Designatedor Person Designated Any personAny person

Responsible Person under the EUTCDResponsible Person under the EUTCD Must have scientific or medical experienceMust have scientific or medical experience

Human Tissue Act Human Tissue Act

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

and tissue from the living or deceased and tissue from the living or deceased for specified purposesfor specified purposes

Removal of material from the Removal of material from the deceaseddeceased

Ethics and HTAEthics and HTA

Human Tissue Act – StatutoryHuman Tissue Act – Statutory

Ethical Approval – Is notEthical Approval – Is not

Research Tissue Storage: Research Tissue Storage: Does it Require a Licence?Does it Require a Licence?

Tissue removalTissue removal Tissue removed and stored for the primary purpose of Tissue removed and stored for the primary purpose of

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

death – Post Mortem Licencedeath – Post Mortem Licence

Tissue removed and stored for the primary purpose of Tissue removed and stored for the primary purpose of researchresearch A specific research project with ethical approval – No A specific research project with ethical approval – No

LicenceLicence Distribution to other researchers (tissue bank) – LicenceDistribution to other researchers (tissue bank) – Licence A possible project in the future – 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 ProjectSpecific Ethically Approved Project

IsIs use of tissue if defined clearly within an use of tissue if defined clearly within an ethically approved projectethically approved project

Is notIs not unspecified research on a specified unspecified research on a specified disease (e.g. ‘For research to prevent disease (e.g. ‘For research to prevent growth of brain tumours’growth of brain tumours’

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

Relevant MaterialRelevant Material

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

Processed material, unless acellularProcessed material, unless acellular

‘‘Waste products’, unless acellularWaste products’, unless acellular

Isolated cells – except cell linesIsolated cells – except cell lines

NRES & TissueNRES & Tissue

Ethically Approved Tissue BankEthically Approved Tissue Bank

VoluntaryVoluntary

2 Types2 Types

1) Ethical approval for storage1) Ethical approval for storage

OrOr

2) Ethical approval for storage and 2) Ethical approval for storage and useuse

Tissue Scenario 1Tissue Scenario 1

Study collects blood from patient groupStudy collects blood from patient group Store plasma for specified hormone Store plasma for specified hormone

measurementmeasurement Whole blood sample sent to a university Whole blood sample sent to a university

for DNA extraction and storagefor DNA extraction and storage Keep remainder of plasma for later Keep remainder of plasma for later

research without current approvalresearch without current approval

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


Study collects blood from patient groupStudy collects blood from patient group Store plasma for specified hormone Store plasma for specified hormone

measurementmeasurement DNA extracted immediately for storage DNA extracted immediately for storage

and subsequent studiesand subsequent studies Keep remainder of plasma for later Keep remainder of plasma for later

research without current approvalresearch without current approvalNo Licence issue: plasma and DNA storage are not regulated


Skin samples collected from patients and Skin samples collected from patients and volunteers for evaluation of structural volunteers for evaluation of structural proteinsproteins

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

No Licence issue: both tissues stored for specified research


Muscle biopsies collected from patients for Muscle biopsies collected from patients for evaluation of defined muscle proteins for a evaluation of defined muscle proteins for a study of myaestheniastudy of myaesthenia

Blood stored for later studies of the Blood stored for later studies of the genetics of muscle diseasegenetics of muscle disease

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


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

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

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


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

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


Kidney biopsies collected for diagnosis Kidney biopsies collected for diagnosis and stored in the Histopathology and stored in the Histopathology DepartmentDepartment

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

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


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

Sends tissue for a research project at a Sends tissue for a research project at a University with no HTA Licence and no University with no HTA Licence and no NRES/IRAS approvalNRES/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


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

No Ethical Approval applied forNo Ethical Approval applied for No current research study being undertakenNo current research study being undertaken

What approvals needed?What approvals needed?

An HTA Licence and approval of the DI

Designated Individual for Research TissueDesignated Individual for Research TissueSteve Hopkins: Ext - 64269Steve Hopkins: Ext - 64269

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

the human tissue act and you steve hopkins designated individual for research tissue

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