Frequently Asked Questions

How many HTA licences does Imperial College have? Who are the designated individuals for the College's HTA licences?

HTA licences and contact details
HTA licence type	Designated individual	Licence Holder	Sector	Premises
12275	Iain McNeish	Ruth Nicholson	Research	Imperial College London
12235	Rachael Waddington		Anatomy	Imperial College London
12388	John Pepper		Research	Imperial College School of Medicine
12608	Ian Bateman		Research	Imperial College Healthcare NHS Trust

What are licensed premises?

Premises are where the licensable activities will take place. The HT Act restricts licensable activities to the premises named on a licence. (https://mrc.ukri.org/documents/pdf/licensing-summary/)

Licensed premises for 12275 HTA licence
University licensed premises	HTA licence type
Charing Cross Hospital campus	Research 12275	Main
Hammersmith Campus	Research 12275	Satellite
St Marys Hospital	Research 12275	Satellite
White City Campus	Research 12275	Satellite
St Marks	Research 12275	Satellite
Chelsea and Westminster	Research 12275	Satellite
South Kensington	Research 12275	Satellite

What consist HTA relevant material?

You can find a list of Relevant and non relevant material in the HTA website: List of materials considered to be ‘relevant material’ under the Human Tissue Act 2004 | Human Tissue Authority

Where can I find more information about the Human Tissue Act and research?

For more information relevant to the research sector, please visit the Human Tissue Authority (HTA)’s website . It includes a frequently asked questions section.

Do all human tissue samples of relevant material need to be stored on HTA licensed premises?

No, there are several exemptions to HTA licensing, which are detailed in the HTA’s Code of Practice E from paragraph 80 and on the HTA’s website. The most common exemption is if the samples are under a current and valid ethical approval from a recognised REC (including samples released under a Research Tissue Bank’s ethical approval).

Do I need to register my samples under an HTA licence if I have ethical approval from the Imperial College Research Ethics Committee (ICREC)?

Yes, because ICREC are not recognised by the HTA for the purpose of licensing exemption.

Recognised RECs are either RECs established under and operating to the standards set out in the governance arrangements issued by the UK health departments, or ethics committees 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. NHS RECs and NRES RECs also refer to recognised RECs.

A list of recognised RECs can be found on the Health Research Authority's website.

My collaborator from abroad is sending samples to analyse at Imperial. There is ethical approval in the country of origin, but not in the UK.

Ethical approval from another country is not a valid exemption from the licensing requirements of the Human Tissue Act. The samples must be registered under an HTA licence, or approval must be sought from a recognised REC to analyse the samples in the UK.

An appropriate research agreement (such as a material transfer agreement or tissue transfer agreement) must be put in place between the institution the samples are being sent from and Imperial College before the samples are transferred to Imperial.

For information on research agreements, please contact your research contracts specialist https://www.imperial.ac.uk/research-and-innovation/research-office/contracts/types-of-contract/ To register samples under the College HTA licence, please contact the Tissue Bank team.

My research project has ended but the samples collected in my Sub-Collection are valuable and I would like to keep them for future research projects.

Provided there is consent to store and use the samples for research beyond the original research project (generic and enduring consent), the designated individual will allow the registration of the samples under a College HTA research licence if the collection complies with HTA standards and the conditions of the applicable licence. Once registered under a licence, the samples may be stored for scheduled purposes including future research.

Please refer to our Sub-collections webpage for more information.

Note that ethical approval is still required for the use of the samples in research.

Samples without any evidence of generic and enduring consent beyond the original research project must not be held.

My samples are non HTA relevant, does it mean I don’t need to track them?

Non HTA relevant samples still need to be fully tracked to comply with REC regulations. The REC Annual Report requires researchers to provide specific information such as: the number of samples collected in the period, the number of samples allocated and used for research projects as well as specific details regarding the research projects which have received samples.

Please see Progress reports - Health Research Authority (hra.nhs.uk) for more details. The template provided for “Annual Report form for Research Tissue Banks” needs to be completed by all sub collections using the REC to collect samples. The Imperial College Healthcare Tissue Bank sends a Microsoft Form to all sub collection PIs to complete and we collate all the information to submit the REC annual report to our Tissue Bank REC. Sub Collection PIs are responsible to provide this report (but this can be delegated to members of their team).

My samples are stored on licensed premises. Is there anything else I need to do to be compliant with the Human Tissue Act?

Unless a valid exemption is in place, the samples must be placed under the governance of the HTA licence. This means that they must be registered under an HTA licence and the collection must be audited against the HTA standards for research. This ensures that the Designated Individual for the licence has oversight of all the samples under the licence and can ensure compliance with the legislation.

If you have a query about HTA licensing requirements at the College, please contact us.

Using samples from living healthy volunteers. What are the requirements in terms of ethical approval and HTA licensing?

Guidance from the Imperial College Research Ethics Committee (ICREC) is available to determine which type of ethical approval, if any, is required for work involving samples from healthy volunteers:

HTA licensing is required if the samples are relevant material, are stored for a scheduled purpose, and there is no ethical approval from a recognised REC (NHS/HRA). For tissue obtained from the living, scheduled purposes do not include:

performance assessment: use of material in the evaluation and assessment of in-vitro diagnostic kits, calibration of devices

education or training related to human health, for example, demonstration of a technique or training to take blood

quality assurance: use of material as part of systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met

Therefore, samples used for performance assessment, education, or quality do not need to be registered under an HTA licence.
The HTA’s Code of Practice E on Research details licensing requirements in paragraph 84.