Research tissue bank FAQs

A ‘research tissue bank’ (‘biobank’) is defined under the Governance Arrangements for Research Ethics Committees (GAfREC) 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’.

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). 

‘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. There is a list of relevant material on the Human Tissue Authority’s (HTA’s) website. 

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.

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’.

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 Scotland do not need a HTA licence.

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’.

Yes, unless the exceptions under the HT Act and associated legislation apply. These are:

• Storing and providing relevant material which is an ‘existing holding’. 
• Storing and providing relevant material which has been obtained from living donors, the researcher is not in possession, and not likely to come into possession, of information that identifies the donor (‘non-identifiable information’) and the material is released by a research tissue bank with generic approval by a ‘recognised Research Ethics Committee (REC)’ for research within the terms of the approval or it is to be used for a specific research project approved by such a REC.
• Storing and providing ‘imported’ material (import into England, Wales or Northern Ireland from a place outside England, Wales and Northern Ireland).
• Storing and providing relevant material which has been donated for research and more than 100 years have elapsed since the person’s death.

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. 

For imported material, there should be mechanisms in place to provide assurance that the tissue has been obtained in the source country with valid consent. The importer should have in place, policies and/or standard operating procedures which clearly set out the evidence indicating how informed consent was obtained, including safeguarding the confidentiality of all information relating to consent. If a separate organisation is importing the material, a documented agreement should be in place demonstrating that there is a record of consent in a suitable format.

Specific consent is given in relation to a defined project, treatment and/or use. 

Broad (generic) refers to consent given to allow the storage and use of tissue for an as yet unknown research project or as part of a research tissue bank. 

Specific and broad consent may be sought at the same time, to derive the greatest benefit from valuable human tissue donated for research.

The types of research for which the tissue will be used should be explained, along with the circumstances under which the tissue will be disposed of.

If the tissue donated will be identifiable, the donor should be informed if they will be contacted by researchers, given feedback, or be asked for access to their medical records.

If a research tissue bank intends to charge for providing human tissue samples to researchers (including those working for private companies) this should be made clear to donors. The research tissue bank should also provide information about how and why they charge, and to whom they will supply the human tissue samples.

If a donor expresses objections to specific types of research, these must be respected.  
The criteria for obtaining valid broad consent from research tissue bank donors can be considered in light of the six ‘key tests’ set out in the joint HRA/HTA report, ‘Consent to use human tissue and linked health data in health research: A Public Dialogue for Health Research Authority and Human Tissue Authority’. 

Not always but broad consent may avoid the need to seek further consent and this avoids a situation where a valuable tissue resource cannot be used for research in the future.

What records should research tissue banks hold to demonstrate consent is in place?
They should hold:
•    Documents used within the research consent process (i.e. participant information sheets and/or consent forms); and/or
•    A legal agreement with another party which confirms that appropriate consent is in place (a copy of a blank participant information sheet and/or consent form could also be provided with the agreement). Signed consent forms should remain with the other party and be retained in line with its local policies.

No, applications are voluntary but REC approval may facilitate programmes of research without a need for individual project-specific REC approval. The RECs: (i) are a source of ethical advice to the research tissue bank on its arrangements for collecting, managing and distributing tissue; and (ii) can advise on informed consent and procedures for providing feedback to donors.

Ethical approval for a research tissue bank also offers additional assurance to end user researchers, donors and the public that its operations meet the highest ethical standards.

For researchers working in NHS Scotland, it is expected that one of the four Healthcare Improvement Scotland-accredited Scottish Health Board research tissue banks will be used. 
The HTA’s remit does not cover REC-approved research tissue banks in Scotland.  

RECs will normally only review research tissue bank applications from organisations within the UK. Applications from outside the UK are only accepted for review if the research tissue bank plans to collect biological samples relating to UK donors. 

The application is made through the Integrated Research Application System (IRAS) by selecting the research tissue bank category. If the research tissue bank will be storing relevant material then the details of the Designated Individual (DI) are required, along with a copy of the licence certificate. The research tissue bank needs to be licensed as some of the human tissue being stored will not be for use in specific REC-approved projects.

An HTA licence, when required, can be applied for at the same time as applying for ethical review or afterwards. However, if relevant material is being stored in the research tissue bank, the bank will not be allowed to operate until the required HTA licence arrangements have been confirmed.

The ethical review applies to the management of the research tissue bank as a whole, including arrangements made with collaborators. There is no requirement for individual research sites involved in human tissue collection (‘Tissue Collection Centres’) or storage to apply for ethical approval. There are, however, licensing implications for Tissue Collection Centres (see below).

The research tissue bank’s ethical approval also 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 and does not need project-specific REC approval. 

If the research is not carried out in accordance with these requirements, a project-specific REC application will be required or the samples will need to be stored under a separate HTA licence.

Approval is given for a period of five years, which may be renewed (for further periods of five years) following submission and review of a renewal application to the REC. 

Yes, an annual report must be provided to the REC. The annual report summarises the research work of the research tissue bank, publications, updated protocols, applications to the research tissue bank and traceability of tissue being distributed from the research tissue bank.

Yes. The application should include information about each collection, including policies for access to tissue in each collection and distribution to external researchers. 
Alternatively, the applicant can submit a separate application for each research tissue bank. 

No. A separate application should be made for each licensed research tissue bank, even if the DI is the same on both licences.  

The management arrangements should ensure that each research application is subject to scientific critique, is appropriately designed in relation to its objectives and is likely to add something useful to existing knowledge. 

Applications to the research tissue bank and decisions on release of tissue to researchers may be considered by an ‘access committee’, usually of senior academics and lay people. This ensures that release of tissue is in line with the terms of the consent given (see below).

Where samples have been donated with broad consent, the research tissue bank must be satisfied that the use of the samples complies with the terms of donor consent. 

Samples and any associated clinical information must be non-identifiable to the researcher at the point of release. 

A supply agreement must be in place with the researcher to ensure storage, use and disposal (or return) of the human tissue samples in accordance with the terms of the research tissue bank’s ethical approval. 

If the researcher wishes to use identifiable clinical information on the samples they have received, they must apply have project-specific REC approval. The research tissue bank’s consent form and participant information leaflet must meet the requirements of the General Data Protection Regulation (GDPR) and the Data Protection Act (2018).

The research application should be submitted to the REC which approved the research tissue bank application.

Yes. The research tissue bank should make this clear to the donor and should also provide information about how it charges, and to whom they will supply the human tissue samples.

No, in some research tissue banks the human tissue is taken out by multiple users almost immediately because of the nature of their work (e.g. fresh tissue is required). There are other research tissue banks which are accessible only to the staff of the company.

No.

Yes, unless the storage at each centre is only for up to seven days before transportation. 

Yes, but the samples must be stored on HTA-licensed premises unless a storage licensing exemption applies (e.g. the research will be carried out under project-specific REC approval).

On completion of such research, the researcher must choose the most appropriate option:

• transfer the human tissue back to the research tissue bank.
• transfer the human tissue to an alternative HTA-licensed establishment.
• apply for their own HTA licence (unless the further storage can be covered by an existing local licence).
• apply for specific project approval by a REC.
• dispose of the human tissue.

Samples used for diagnosis may be stored in an archive to benefit the person’s medical care. These samples can also be valuable resources for health research. Purely diagnostic archives do not need to be stored on HTA-licensed premises as no licensable activity would be taking place. However, the HT Act clearly provides that the storage of tissue for a ‘scheduled purpose' must be on licensed premises. 

The material is usually in the form of formalin-fixed, paraffin-wax embedded (FFPWE) blocks and sections cut from these blocks on glass slides. The archive may also contain frozen tissue and frozen tissue sections.

If a diagnostic archive releases tissue for research occasionally upon request, its status as a diagnostic archive remains clear and it doesn’t need to be covered by a HTA storage licence. If there is an expectation that tissue will be released on a regular basis, then it may cease to be a purely diagnostic archive, particularly where there are developed governance / decision-making structures and procedures for applying for tissue.

If the archive functions as a resource for researchers (by inviting applications for the release of samples or advertising the archive as a research resource), it is functioning as a research tissue bank and needs to be covered by a HTA storage licence. 

Not necessarily. If the diagnostic archive is based on premises already licensed by the HTA for storage (e.g. under an Anatomy, Human Application or Post-Mortem licence), providing the DI is willing to take responsibility for the governance of the archive, the existing 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.