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Consent Update

Consent Update. Gail Jenner CCLG Tissue Bank Support and Education. Human Tissue Act. Became law in Sept 2006 Detailed statutory framework, codes of practice (UK Human Tissue Authority) Storage and use of tissue predominantly regulated by HTA

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Consent Update

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  1. Consent Update Gail Jenner CCLG Tissue Bank Support and Education

  2. Human Tissue Act • Became law in Sept 2006 • Detailed statutory framework, codes of practice (UK Human Tissue Authority) • Storage and use of tissue predominantly regulated by HTA • Tissue stored for research must have a HTA licence

  3. Human Tissue Authority • Codes of Practice • Practical guidance for professionals • ‘Consent’ & ‘Research’ (September 2009)

  4. Surgical removal and pathology handling of tissue • Surgical consent covers storage of samples for diagnostic purposes • Tissue can be held indefinitely as part of the consent to treatment/procedure • Scheduled purposes (Schedule 1 HTA)

  5. Consent Exception • Clinical audit • Education and training • Performance Assessment • Public Health Monitoring • Quality Assurance

  6. Research without Consent • Researcher must not obtain information that identifies the patient • The material is used for a specific project with ethical approval

  7. Consent and the Law • Treatment and examination covered by ‘common law’ • Consent for ‘scheduled purposes’ under HT Act • Consent can be combined, principles the same

  8. HTA and provision for ‘competent’ children • Child defined as under 18 years old,16 in Scotland (HTA) • The child’s consent is sufficient to make lawful removal of tissue for scheduled purposes • Age and level of understanding must be taken into account • Discuss with family

  9. Who may seek consent • Healthcare professional • Procedures in place outlining responsibilities • Training and support • Good understanding of processes. • Enduring consent • recommended

  10. Withdrawal of consent • Right to withdraw at any time • Cannot be effective where tissue has already been used • Samples do not need to be destroyed • Information and research data remain for existing projects.

  11. Existing Holdings • HT Act not retrospective (1 Sept 2006) • Ethical consideration • Licensing requirements remain

  12. Consent Forms • To remain in banking centre • Signed confirmation at CCLG • Regular audit to comply with HTA inspections

  13. Supported by CCLG Central Tissue Bank (Tissue Storage Location) Newcastle Biomedicine Biobank Faculty of Medical Sciences4th Floor Leech BuildingNewcastle Upon Tyne, NE2 4HH Tel: 01912464442 Fax: 0191 246 4301 website: www.ncl.ac.uk/nbb/ 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

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