1. HTA Update Andy Hall 6/7/2011

2. Roles (Research Licence) Licence holder Designated Individual Person Designate Lab staff Person Designate Lab staff Person Designate Quality Assurance Manager (optional)

3. Designated Individuals 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

4. Scope of the HTA 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

5. “Relevant material” 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

6. “Relevant material” Exclusions 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

7. Slides Blocks INCLUDED

8. Current advice 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)

9. Codes of Practice Applicable for Research 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/ http://www.hta.gov.uk/

10. HTA inspection 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

11. Newcastle HTA inspection 19-20 th 2011  Notification of inspection- January 2011  Request for summary of collections held under research licence  Selection of sites to be inspected  On-site inspection

12. Inspection Process  Two inspectors- sometimes working independently  1:1 interviews with DI, Quality Assurance Manager and selected PDs  Site inspection  Audit trail of samples- backwards and forwards, 3-4 samples  Discussion of facilities  Consent arrangements  Wrap-up session  Written report- published on HTA web site (coming soon!)

13. Inspection Outcomes  No conditions or major findings  Recommended  Improved audit for consent  Preparation of a “Quality Manual”  System for ensuring collections for specific purposes are destroyed or transferred at end of projects

14. January 2001 “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.”

15. CCLG Coordinating Centre (Tissue Bank Coordination) 3rd Floor, Hearts of Oak House 9 Princess Road West Leicester, LE1 6TH Tel: 0116 249 4460 Fax: 0116 254 9504 website: www.cclg.org.uk CCLG Central Tissue Bank (Tissue Storage Location) Newcastle Biomedicine Biobank Faculty of Medical Sciences 4th Floor Leech Building Newcastle Upon Tyne, NE2 4HH Tel: 01912464442 Fax: 0191 246 4301 website: www.ncl.ac.uk/nbb/ Supported by

16. Any Qustions