Licensing and pathology archives

In England, Wales and Northern Ireland
Diagnostic archives of human tissue do not require to be held under an HTA Licence. However, in the following circumstance a licence would be required:

  • If the primary purpose of the collection changes from diagnosis to supporting research, the tissue held within the collection (provided it falls under the definition of relevant material) will then require to be held under an HTA licence or a project specific ethics approval, given by an NHS REC (see HTA Licence for further detail).
  • If blocks or sections cut from blocks are released for research, either to Pathologists working with the same department or to other researchers based in England, Wales or Northern Ireland, these researchers must hold the released blocks either under an HTA Licence or must obtain project specific ethics approval from an NHS REC (see HTA Licence).
  • The requirement for a licence is in addition to the requirement for consent or fulfilment of the consent exemptions (see Using diagnostic archives without consent).

In Scotland
There is no licence scheme in Scotland for establishments that hold human tissue for research or for diagnostic purposes.  The Scottish Government has developed an accreditation scheme which assures that the main research tissue resources held within NHS Scotland are managed appropriately. For more information please see the Scottish Health Department letter SGHD/CMO(2011)7.

This accreditation scheme is not open to diagnostic collections and should not be confused with UKAS Accreditation scheme (which is replacing the Clinical Pathology Accreditation scheme). The UKAS accreditation is a voluntary, government recognised scheme which applies UK wide and provides a means to accredit Clinical Pathology Services and External Quality Assessment Schemes (EQA). For further information on this scheme please visit the UKAS website.