Position statement on diagnostic archives
Joint statement from the HTA and National Research Ethics Service (NRES)
Issued 29 July 2009
Licensing
Tissue that is taken from the living for diagnosis and subsequently stored in a diagnostic archive can be a valuable research resource.
Purely diagnostic archives do not need to be stored on HTA-licensed premises. However, the Human Tissue Act 2004 (HT Act) clearly provides that the storage of tissue for a ‘scheduled purpose' must be on licensed premises. Where a diagnostic archive functions as a resource for researchers as it invites applications for the release of samples, and / or in any way advertises the archive as a research resource, it is functioning as a research tissue bank. It must therefore be encompassed within the HTA's licensing framework. This legal requirement stands, even where tissue released from the archive will only ever be used as part of a specific project approved by a NHS research ethics committee (REC).
Where the archive is on premises already licensed by the HTA for storage, providing the Designated Individual (DI) is willing to take responsibility for the governance of the archive, the licence can be extended in anticipation of the archive operating as a research tissue bank.
Where the archive is on premises not licensed by the HTA for storage, a new licence application will need to be submitted prior to the archive operating as a research tissue bank.
If you require a new licence you need to complete a new research compliance report application via the HTA website at /_db/_documents/2006-06-28_Designed_Research_Compliance_Report_on_the_website_amended.pdf
If the archive is on a site that can be linked to existing HTA-licensed premises you can apply for a satellite licence at /_db/_documents/2006-07-03_Satellite_Establishment_Information_on_website_v0_200806030415.doc
If you require an HTA licence e.g. a post mortem licence, to be extended to cover a diagnostic archive that is not yet functioning as a research tissue bank, you need to email enquiries@hta.gov.uk quoting the existing HTA licence number and provide a brief narrative about where on the premises the archive is held (attaching a site map if possible) and how the DI is going to ensure the archive functions within the establishment's existing governance and quality system.
You should allow three months from submission of a new application to the grant of a licence and one month following the submission of a satellite application or a licence extension request.
If you are inviting applications for the release of samples, and / or in any way advertising an archive as a research resource and it is not on HTA-licensed premises, you must stop doing so immediately and contact the HTA at the enquiries email address above. You must not re-commence releasing tissue until you have been granted an extension to an existing HTA licence or a new HTA licence. If you are aware of any other establishment that this applies to, please contact the HTA.
Ethical approval
The HTA and National Research Ethics Service (NRES) have agreed a position whereby NHS research ethics committees (RECs) can give generic ethical approval for a research tissue bank's arrangements for collection, storage and release of tissue, providing the tissue in the bank is stored on HTA-licensed premises. This approval can extend to specific projects receiving non-identifiable tissue from the bank. The tissue does not then need to be stored on HTA-licensed premises; nor does it need project specific ethical approval.
Applications for ethical review of research tissue banks are voluntary.
Applications for ethical review may be made by diagnostic archives planning to operate as research tissue banks. Generic ethical approval will be subject to licensing by the HTA in the same way as for other approved banks.
If the archive does not gain generic research tissue bank approval the tissue can only be released as follows:
- to another HTA-licensed establishment, or
- for use in a specific project with ethical approval by a REC; therefore negating the need for it to be stored under the authority of an HTA storage licence.
For further information about ethical review of research tissue banks, see http://www.nres.npsa.nhs.uk/applications/apply/ethical-review-requirements/#RequirementsRTBs
Applications for ethical review of research tissue banks can be prepared using the Integrated Research Application System (IRAS), available at https://www.myresearchproject.org.uk/. Detailed guidance for applicants is available within IRAS. Applications should be booked for ethical review through the NRES Central Allocation System (0845 270 4400). NRES has designated particular RECs ("flagged RECs") to review applications from research tissue banks.
Consent
Whenever identifiable tissue is released for research from a diagnostic archive, it must only be released in accordance with the donor's consent; unless it was stored prior to implementation of the HTA Act on 1 September 2006, in which case consent is not required, as it is regarded as an "existing holding".
Tissue that has not been consented for research (other than existing holdings) can only be released if it is from a living person, and
- the researcher is not in possession, and not likely to come into possession of information that identifies the person from whom it has come;
AND
- where the material is released by a research tissue bank with generic ethical approval from a REC for research within the terms of the approval
OR
- it is to be used for a specific research project approved by a REC.
There may be occasions when a clinician involved in research has access to a secure database that would permit identification of a sample and the identity of the patient whose material is being used. Providing the research material is not identifiable to the researcher (e.g. coded by a laboratory accession number) and the researcher does not seek to link the tissue to the patient, the sample will still be regarded as non-identifiable and the research will be permissible without consent if it is given ethical approval by a REC.