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Ethical review of research tissue banks ('biobanks')

Organisations responsible for the management of research tissue banks (RTB, or 'biobank') anywhere in the UK may apply for ethical review of their arrangements for collection, storage, use and distribution of tissue.

Applications should be made using the appropriate form in IRAS.

 

An RTB is defined as:

A collection of human tissue or other biological material, which is stored for potential research use beyond the life of a specific project with ethical approval or for which ethical approval is pending.

Applications are not restricted to collections of human tissue within the definition of 'relevant material' under the Human Tissue Act 2004.

 

There is no formal requirement for RTBs to obtain ethical approval under the Human Tissue Act or NHS research governance systems. Applications for ethical review will therefore be made on a voluntary basis.

 

However, ethical approval for an RTB may have benefits by facilitating programmes of research without a need for individual project-based ethical approval. The RTB application form has an option for the applicant to seek generic ethical approval prospectively for a range of research to be carried out by the establishment responsible for the bank and/or by other researchers to whom tissue is released by the bank within the conditions of the ethical approval. Such approval may be given for a period of up to five years and will be renewable. 

 

Human Tissue Authority Licensing

Under the Human Tissue Act, RTBs in England, Wales and Northern Ireland storing relevant material for use in as yet unspecified research must obtain a licence from the Human Tissue Authority (HTA).

 

It is strongly recommended that any application for ethical review is made to a flagged REC for research tissue banks.  Flagged RECs can be identified using the advanced search tool in our Find your local REC section.


Applicants for ethical review of RTBs will be expected to provide the REC with a copy of the licence as a condition of ethical approval except where:

 

  • The RTB is established in Scotland.

  • The biological material to be stored for use in research is outside the definition of 'relevant material' under the Human Tissue Act, for example DNA, plasma, serum, cell lines.

Further Guidance

Detailed guidance on licensing is available from the HTA.



Further guidance on RTB applications is available in:

 


NRES and the Human Tissue Authority have issued a joint statement on the release of tissue for research by diagnostic archives.