Under the Human Tissue Act 2004, the HTA is required to license the storage of relevant material for ‘research in connection with disorders, or the functioning, of the human body’. This requirement applies to the storage of all relevant material, whether it has come from a living or a deceased person, and applies across all of England, Wales and Northern Ireland. There is an exception to this licensing requirement in cases where relevant material is being stored for ’qualifying research’ which is research that has received approval from a recognised research ethics committee (REC) or is a specific research project for which such ethical approval is pending . This means that although much storage of research material is exempt from HTA licensing, the requirement to be licensed is relevant to many collections of research material, including those considered to be tissue banks.
The HTA and the HRA’s Research Ethics Service (HRA RES) have agreed a position whereby NHS 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. Such research tissue banks need to be licensed because at least some of the tissue being stored is not for specific projects holding REC approval. The banks are also required to work under HRA RES Standard Operating Procedures (SOPs). Applications for ethical review of research tissue banks are voluntary.
Subject to conditions, the bank’s ethical approval extends to specific projects receiving non-identifiable tissue from the bank. The tissue does not then need to be stored on HTA-licensed premises for the duration of the project; nor does it need project specific ethical approval. If the research is not carried out in accordance with these requirements, specific project approval by a recognised REC will be required or, alternatively, the samples will need to be stored under a HTA licence.
The RECs are also a source of ethical advice to the bank on its arrangements for collecting, managing and distributing tissue. In particular, the RECs can advise on informed consent and procedures for providing feedback to participants. Ethical approval for a research tissue bank offers additional assurance to end user researchers, donors and the public that its operations meet the highest ethical standards.
When applying for REC review, applicants are advised by the HRA to request review by a REC ‘flagged’ to review research tissue banks (RTBs).
Some research banks hold material which is not considered ‘relevant material’ under the Human Tissue Act 2004. Examples of these would be banks which store only DNA or serum. There is no requirement for such banks to hold a HTA licence.
For further information about ethical review of RTBs, see:
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 as no licensable activity would be taking place. However, the Human Tissue Act 2004 clearly provides that the storage of tissue for a ‘scheduled purpose' must be on licensed premises. The HTA’s position is that if a diagnostic archive releases tissue for research occasionally upon request, its status as a diagnostic archive is clear. However, if there is an expectation that tissue will be released on a regular basis, then it ceases to be a purely diagnostic archive, particularly where there are developed governance / decision-making structures and procedures for applying for tissue.
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 RTB. 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 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 RTB.
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 RTB.
If you require a new licence, you need to complete an application via the HTA website.
If the archive is on a site that can be linked to existing HTA-licensed premises, you can apply for a satellite licence via the HTA website.
If you require an existing HTA licence e.g. a post mortem licence, to be extended to cover a diagnostic archive that is not yet functioning as a RTB, you need to email Licensing.Enquiries@hta.gov.uk quoting the HTA licensing 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.
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 a new HTA licence or sought an extension to an existing HTA licence. If you are aware of any other establishment that this applies to, please contact the HTA.
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 the material 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,
- the researcher is not in possession, and not likely to come into possession of information that identifies the person from whom it has come;
- where the material is released by a RTB with generic ethical approval from a REC for research within the terms of the approval
- 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.
As outlined above, applications for ethical review may be made by diagnostic archives planning to operate as RTBs. If the archive does not gain generic RTB 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 a HTA storage licence.
Updated July 2015