General 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  

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. 

Licencing and Ethical Approval Requirement Questions

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 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: 

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

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

  1. 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.