hta update andy hall 6/7/2011. roles (research licence) licence holder designated individual person...

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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Any Qustions