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There are 12 scheduled purposes described in Schedule 1 of the HT Act. The scheduled purpose which relates to research is ‘Research in connection with disorders, or the functioning, of the human body’.
An existing holding is material from the living or deceased that was already held for use for scheduled purposes when the HT Act came into force on 1 September 2006.
‘Relevant material’ is material other than gametes, which consists of, or includes, human cells. Relevant material does not include: (a) embryos outside the human body, or (b) hair and nail from the body of a living person.
A research tissue bank can store different types of biological material, including DNA, serum, cell lines and/or ‘relevant material’. ‘Relevant material’ is defined by the Human Tissue Act 2004 (HT Act).
A ‘research tissue bank’ (‘biobank’) is defined under the Governance Arrangements for Research Ethics Committees (GAfREC) as:
We were asked to provide original documentation submitted as part of King's Health Partners Cancer Biobank's application for an HTA licence.
Last summer, the Health Research Authority (HRA) and the Human Tissue Authority (HTA) - in partnership with the Department for Business, Enterprise, Innovation and Skills’ (BEIS) Sciencewise programme and Ipsos MORI - published the report ‘
The HTA was asked to provide information on whether the company ‘Celixir’ had an HTA licence from 2010-13, for importing blood from patients at the Morriston Hospital and deriving mesenchymal stromal cells for research purposes.