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If practicable, the consent of a research donor should be sought wherever possible and the views of the relatives of a deceased person must be respected.
Yes, unless the exceptions under the HT Act and associated legislation apply. These are:
Some research tissue banks act as co-ordinating bodies for organisations, facilitating access of tissue, including tissue which can be imported for use. These can include commercial organisations and pathology ‘networks’.
Research tissue banks storing relevant material ordinarily require a storage licence from the HTA. Those storing other material (e.g. serum, DNA, cell lines) do not. As the HT Act, and the remit of the HTA, applies only to England, Wales and Northern Ireland, research tissue banks based in...
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.