Position statement on extending existing 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 the “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.

We have been working with individual establishments to extend existing removal licences where there is a local need. We have worked with transplant professionals, the Department of Health and partner organisations to identify and evaluate possible options within the legal framework. Extending existing licences is the swiftest and most light touch approach we can take while we explore options, which include the possible introduction of a new type of licence specifically for the removal of tissue from the deceased.

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.

Designated Individuals (DIs) who wish to extend their removal licence can request an extension by writing to the HTA, via licensing.enquiries@hta.gov.uk

More information about licensing is available on our website.