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HTA Update
Andy Hall
Children’s Cancer and Leukaemia Group‘Caring for children – curing their cancer’
6/7/2011
Roles (Research Licence)
Children’s Cancer and Leukaemia Group‘Caring for children – curing their cancer’
Licence holder
Quality Assurance Manager (optional)
Designated Individual
Person Designate
Lab staff
Person Designate
Lab staff
Person Designate
Designated Individuals
Children’s Cancer and Leukaemia Group‘Caring for children – curing their cancer’
• Locally nominated “suitable” individuals• Responsible for overseeing licensed activity• Failure may lead to fine or imprisonment or both
Andy Hall – DI for University Research Licence
Scope of the HTA
Children’s Cancer and Leukaemia Group‘Caring for children – curing their cancer’
• Covers material collected for generic purposes• Material collected for a specific purpose need
not be registered- but – MUST be destroyed at the end of the project and
the project – MUST have current LREC approval
“Relevant material”
Children’s Cancer and Leukaemia Group‘Caring for children – curing their cancer’
• The HT Act regulates removal, storage and use of human tissue – defined as material that has come from a human body and consists of, or includes, human cells. It is unlawful to carry out these activities without a licence
• The HT Act creates a new offence of DNA ‘theft’. Having human tissue with the intention of its DNA being analysed, without the consent of the person from whom the tissue came, is unlawful. However, extracted DNA need not be registered under the Act
“Relevant material”Exclusions
Children’s Cancer and Leukaemia Group‘Caring for children – curing their cancer’
• Gametes (HFEA)• Embryos outside the human body (HFEA)• Hair and nail from the body of a living person• Plasma and serum• Cultured cells which have divided outside the
body• Cell lines
Slides
Blocks
INCLUDED
Current advice
Children’s Cancer and Leukaemia Group‘Caring for children – curing their cancer’
• Plasma and serum are out, • Urine and faeces are in (unless rendered
acellular)• Bones are in (unless ground up and irradiated)
(See HTA web site for updates, 2 lists)
Codes of Practice Applicable for Research
Children’s Cancer and Leukaemia Group‘Caring for children – curing their cancer’
• Code of Practice 1 – Consent• Code of Practice 5 – Disposal• Code of Practice 8 – Import and Export of
Human Bodies, Body parts or Tissues• Code of Practice 9 – Research
– Codes all available on HTA website http://www.hta.gov.uk/
HTA inspection
Children’s Cancer and Leukaemia Group‘Caring for children – curing their cancer’
• Risk based; Research collections are low risk but some will be selected at random
• Ask for consent form at random and trace sample through collection, storage and use
• Good documentation is vital
Newcastle HTA inspection19-20th 2011
Children’s Cancer and Leukaemia Group‘Caring for children – curing their cancer’
Notification of inspection- January 2011
Request for summary of collections held under research licence
Selection of sites to be inspected
On-site inspection
Inspection Process
Children’s Cancer and Leukaemia Group‘Caring for children – curing their cancer’
Two inspectors- sometimes working independently1:1 interviews with DI, Quality Assurance Manager and selected PDsSite inspection
Audit trail of samples- backwards and forwards, 3-4 samples
Discussion of facilities Consent arrangements
Wrap-up sessionWritten report- published on HTA web site (coming soon!)
Inspection Outcomes
Children’s Cancer and Leukaemia Group‘Caring for children – curing their cancer’
No conditions or major findingsRecommended Improved audit for consent Preparation of a “Quality Manual” System for ensuring collections for specific
purposes are destroyed or transferred at end of projects
January 2001
Children’s Cancer and Leukaemia Group‘Caring for children – curing their cancer’
• “Ann and Tony Darracott, whose five year old son Phillip died 12 years ago were devastated to be told that the hospital had kept his heart, brain and abdominal organs.
• "It didn't seem right a heart belonging to my child could be part of a collection like butterflies, or insects, something to be visited and looked at," …..
• But some said that if asked they would have donated some organs for research or transplantation if it was to help other sick children.”
CCLG Coordinating Centre (Tissue Bank Coordination)3rd Floor, Hearts of Oak House9 Princess Road WestLeicester, LE1 6TH
Tel: 0116 249 4460
Fax: 0116 254 9504
website: www.cclg.org.uk
Children’s Cancer and Leukaemia Group‘Caring for children – curing their cancer’
CCLG Central Tissue Bank (Tissue Storage Location)Newcastle Biomedicine BiobankFaculty of Medical Sciences4th Floor Leech BuildingNewcastle Upon Tyne, NE2 4HH
Tel: 01912464442
Fax: 0191 246 4301 website: www.ncl.ac.uk/nbb/
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