The Human Tissue Act and You

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The Human Tissue Act and You

• Steve Hopkins
• Designated Individual for Research Tissue

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

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Review of the Law 2000-2004

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

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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.

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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

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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

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The HTAs 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

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Licensed Sectors

• Tissue for human application
• Post Mortem services
• Anatomy
• Public display
• Research

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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

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HTA Governance Framework

• Designated Individual
• Licence applicant (if different to DI)
• Person Designated a person to whom the Licence
  applies
• Persons acting under the direction of a DI or
  Person Designated by DI

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HTA Governance Framework
Licence
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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

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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

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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

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Governance

• Persons acting under the direction of a DI or
  Person Designated
• Any person
• Responsible Person under the EUTCD
• Must have scientific or medical experience

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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

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Ethics and HTA

• Human Tissue Act Statutory
• Ethical Approval Is not

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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

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PRIMARY PURPOSEResearch
Is it stored for a specific ethically approved
research project?
No
Yes
Is a licence required?
Is a licence required?
Is consent required?
Is consent required?
Yes, unless material is obtained from a living
person and is anonymised
Yes
Yes
No
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Specific Ethically Approved Project

• Is use of tissue if defined clearly within an
  ethically approved project
• Is not unspecified research on a specified
  disease (e.g. For research to prevent growth of
  brain tumours
• Is not research where the tissue collection is
  specified in an ethics application but the
  specific use is not.

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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

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NRES Tissue
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NRES Tissue
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NRES Tissue
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NRES Tissue
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Ethically Approved Tissue Bank

• Voluntary
• 2 Types
• 1) Ethical approval for storage
• Or
• 2) Ethical approval for storage and use

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Tissue Scenario 1

• Study collects blood from patient group
• Store plasma for specified hormone measurement
• Whole blood sample sent to a university 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
university, if stored, but plasma is not
regulated
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Tissue Scenario 2

• 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
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Tissue Scenario 3

• Skin samples collected from patients and
  volunteers for evaluation of structural proteins
• Blood stored for later extraction of DNA to
  analyse genes for these proteins

No Licence issue both tissues stored for
specified research
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Tissue Scenario 4

• Muscle biopsies collected from patients for
  evaluation of defined muscle proteins for a 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
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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
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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
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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
diagnosis and the specific project is ethically
approved
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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 a
  University 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
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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
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http//www.hope-academic.org.uk/irr/hta/

• Designated Individual for Research Tissue
• Steve Hopkins Ext - 64269