Research FAQs

Schedule 1 of the Human Tissue Act 2004 (the Act) sets out ‘performance assessment’ as a ‘scheduled purpose’.

An HTA licence is required if the human cellular material (‘relevant material’) to be stored for performance assessment has been removed from the deceased.

The Act also sets the requirement that consent must be obtained to store and use relevant material from deceased persons for the purpose of performance assessment.

These consent and licensing requirements do not apply if the relevant material has been removed from the living. However, this does not mean that consent to store and use relevant material for this purpose should not be sought where it appropriate and reasonable to do so.

In Vitro Diagnostic Medical Devices
Some companies store and use relevant material to evaluate ‘in vitro diagnostic medical devices’ (IVDs), such as pregnancy test kits, which are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA).

The regulation of IVDs mandates certain types of testing to ensure that they are safe and effective. Where relevant material is stored and used to carry out the mandatory testing of IVDs, this activity is regarded by the HTA as ‘performance assessment’ as set out in the Act.

The activity is therefore exempt from the consent and licensing requirements under the Act, provided that the material has been removed from the living. If the relevant material is obtained from the deceased, then advice from the HTA should be sought.

If an establishment intends to store relevant material for research informing the development of new IVDs, advice from the HTA about consent and licensing requirements should also be sought.

Information on the regulation of human tissue research, including exemptions from HTA licensing, can be found in our Code of Practice on Research.

If information on the regulation of IVDs is required, please contact the MHRA.

No. Importantly, an HTA licence is for the storage for use in research, not the use itself. Specific research projects undertaken with approval from recognised Research Ethics Committee (REC) committees (or for which approval by such a committee is pending), do not require an HTA storage licence. (This is discussed further below in the question ‘‘Do I need a licence to store tissue or cells for a specific research project if it has ethical approval?’’) In addition, researchers storing tissue samples received from a REC-approved tissue bank do not require a HTA storage licence. Finally, storage that is incidental to transportation or with the intent to render material acellular does not require an HTA licence. More information on the requirements for consent and ethical approval is included in flowcharts within the Code of Practice on Research.

No. There is no research that has been conducted in the past, or is currently being conducted, that would be prevented by the HT Act. It simply requires consent or, in the case of tissue from the living (including surplus tissue left over after diagnosis or surgery), ethical approval by a research ethics authority and anonymisation. This is wholly in line with current good practice.

No. The HT Act does not apply to tissue or cells from living people used for diagnosis or blood used for treatment. (So screening for cervical cancer for example is excluded; and an HTA licence is not needed for storage of blood for transfusion.)

Yes. They are particularly well-placed to ask for their patients' consent. If they wish to do research without asking their patients' consent, the research project will need to be approved by a recognised Research Ethics Committee (REC) which is either:

• a REC established under and operating to the standards set out in the governance arrangements issued by the UK Health Departments, or
• an ethics committee recognised by the United Kingdom Ethics Committee Authority (UKECA), to review clinical trials of investigational medicinal products under the Medicines for Human Use (Clinical Trials) Regulations 2004.

Further details are given in the code of practice on Research at. In addition, the researcher must arrange the research so that they do not have access to information identifying the person from whom the tissue came. This does not mean that the records and tissue must be permanently unlinked.

Yes, consent can be generic and enduring. The HT Act sets the baseline that, for lawful storage and use of tissue for Scheduled Purposes, consent must be obtained from the appropriate person. The scope of that consent is not limited by the HT Act. Guidance for obtaining consent is provided in the HTA’s codes of practice and other documents. It can be whatever is agreed in different circumstances. Anticipating and explaining the purpose for which tissue could be used will avoid the need for seeking repeated consents – for example for research after the patient has had surgery or giving tissue which may be stored for use in a future, unspecified, project.

No, it doesn’t. The linked data would need to be anonymised so that the researcher could not know the identity of the person whose tissue was involved, but it does not need to be permanently unlinked.

According to the HT Act, consent from the deceased person, a person nominated by them, or a person in a ‘qualifying relationship’ (usually a family member) will be needed to carry out any research on tissue from the deceased. After coroners have completed their work, the body and tissue must either be:

• Disposed of sensitively
• Returned to the family
• Consented for use for another Scheduled Purpose such as research, clinical audit or public health monitoring.

‘Residual’ blood or tissue from the living can be used without consent only if the research is ethically approved by a recognised Research Ethics Committee (REC; see above and the Code of Practice on Research) and the researcher cannot link the blood or tissue to the patient. Consent is needed for any of the HT Act’s Scheduled Purposes where the tissue is from a deceased person.

No. Research can take place without patients' consent if the tissue has been anonymised and the project has been approved by a recognised Research Ethics Committee (REC) which is either:

• a REC established under and operating to the standards set out in the governance arrangements issued by the UK Health Departments; or
• an ethics committee recognised by United Kingdom Ethics Committee Authority (UKECA), to review clinical trials of investigational medicinal products under the Medicines for Human Use (Clinical Trials) Regulations 2004, (further details are given in the code of practice on Research at,) or is pending such approval.

Use of existing tissue holdings (material from the living or deceased that was already held at the time the HT Act come into force on 1 September 2006) does not need legally require consent. However, if practical, the consent of the participant should be sought and the views of the deceased person or of their family (if known) must be respected. In addition, the potential benefits of the research should outweigh any potential harm to donors of the samples. Further details are given in the Code of Practice on Research. Of interest, although the work on Helicobacter pylori and stomach ulcers was often cited as an example of what could be lost to UK science as a result of the HT Act, this ground-breaking research into the cause of such ulcers actually took place in Australia.

No. An HTA licence is not needed for storage of tissue for certain ethically approved research or a specific research project for which ethical approval is pending from a recognised Research Ethics Committee (REC), which is either:

• a REC established under and operating to the standards set out in the governance arrangements issued by the UK Health Departments, or
• an ethics committee recognised by the United Kingdom Ethics Committee Authority (UKECA), to review clinical trials of investigational medicinal products under the Medicines for Human Use (Clinical Trials) Regulations 2004.

The HTA and National Research Ethics Service (NRES) 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. 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. However, a licence is required for material stored (e.g. in large biobanks) for which there is no ethical approval.

Whether the storage of tissue requires a licence under the Human Tissue Act (HT Act) depends on the primary purpose for which the tissue is taken and stored. If the primary purpose for taking the tissue is for diagnostic purposes, then storage of that tissue is not licensable under the HT Act. If the primary purpose for taking and storing tissue is for research, then an HTA licence is required for storage of the tissue unless a licensing exemption applies. Tissue stored for research that does not have recognised Research Ethics Committee (REC) approval (see above) must be stored under a licence granted by the HTA.

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.

Both consent and a licence are needed to store any tissue or cells for the purpose of genetic testing. A licence is not required to store DNA if it is not associated with cells.

Tissues and cells removed directly from a person are relevant material under the HT Act. Cell lines are not relevant material as all the original cells from the person have been replaced by cells that have divided and therefore have been created outside the human body. The storage of cell lines for research under the HT Act does not require an HTA licence.  Primary cell cultures that have divided to an extent that all the original cells have been replaced by new cells created within the culture are also not considered to be relevant material, and so also do not require an HTA licence for storage for research under the HT Act.

The HTA considers research to be a study which addresses clearly defined questions, aims and objectives in order to discover and interpret new information or reach new understanding of the structure, function and disorders of the human body. Research attempts to derive new knowledge and includes studies that aim to generate hypotheses, as well as studies that aim to test them or develop practical applications or new knowledge. In addition, the HTA endorses the definition provided by the Department of Health and the Welsh Assembly Government, which is as follows: ‘‘Research can be defined as the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods.’’
However, human tissue might be stored and used for another scheduled purpose that might first be thought of as research, for example:

Performance assessment

This term is intended to encompass use of material in the evaluation and assessment of in-vitro diagnostic kits. This is to make it quite clear, for example, that surplus diagnostic tissue can continue to be used to calibrate and assess the comparative performance of medical devices without specific consent.

Quality assurance

A programme for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met.

This includes separate examination or testing of tissue in order to ensure a high quality service and effective clinical procedures and diagnostic tests. In practice, this term could cover a review of the whole diagnostic process, including checking how information relating to tissue is recorded. The review is not, for example, limited to checking the accuracy of apparatus.

Clinical audit

A process to review explicit criteria, and the implementation of change, to continuously improve patient care and outcomes.
This is a means of finding out whether what is being done is appropriate and is being done correctly. For example, are guidelines being followed? Is best practice being applied? Tissue stored in diagnostic archives may need to be reviewed as part of the clinical audit process.