Last updated on 22 Feb 2021
Extending licences to cover the removal of tissue from the deceased for research
The Human Tissue Act 2004 requires that the removal of tissue from the deceased for research within the scope of the Act must always be licensed, on specified premises, and that specific minimum requirements are met.
This means that if, for example, a person wishes to remove relevant material from a deceased organ donor for research ‘in connection with disorders, or the functioning, of the human body’, the removal must always take place on premises licensed by the HTA for that purpose.
Nine out of every 10 post mortem establishments hold this type of removal licence within their suite of HTA licences. Following a request from the relevant Designated Individual (DI), the HTA can extend an existing licence on the same premises in an NHS Trust to cover areas outside the mortuary, such as operating theatres. Where the removal takes place on other premises, for example in an operating theatre located in a different hospital, then a satellite licence arrangement may be required.
The DI named on the HTA licence has statutory responsibility for ensuring that the premises are ‘suitable’ and that ‘suitable practices’ take place on them, as well as for meeting the conditions of the licence. Therefore, the Licence Holder will need to ensure that the DI is content for their remit to be extended to any new areas of responsibility and that the DI will oversee compliance with relevant HTA standards. For HTA to be satisfied about the suitability of the new arrangements, we ask DIs requesting an extension to a licence to confirm they have assured themselves that necessary systems and documentation are in place govern the activity of removal. In particular, the HTA advises that a ‘Person Designated’ is nominated to assure the DI, on an ongoing basis, that suitable practices are being undertaken by suitable people.
DIs who wish to extend their existing licence to cover the removal of tissue from the deceased for research can find out further information by emailing firstname.lastname@example.org.
Supplementary guidance on the HTA’s broader policy framework on ‘relevant material’ can be found on our website, with a non-exhaustive list of human body parts, tissues and cells which are defined as ‘relevant materials’ for the purposes of the Human Tissue Act 2004. Where a material is not included within the list, stakeholders should refer to the policy framework to formulate their own assessment of the material’s status, in line with the guidance provided in the framework.
Updated 18/12/2015 to suggest contacting licensing enquiries, rather than applying for removal licence.