The HTA regulates establishments in England, Wales and Northern Ireland that conduct licensed activities under the Human Tissue Act 2004 (HT Act). This includes establishments that remove samples from the deceased for certain purposes in the HT Act – called scheduled purposes. Read more information about the scheduled purposes.
Removing samples from the deceased for a scheduled purpose can only take place with appropriate consent (or coronial or police authority) and on HTA licensed premises.
If a sample is known to contain a single cell from a human body, then the sample is relevant material and is covered by the legislative requirements of the HT Act. This includes samples such as nose and throat swabs, muscle and skin biopsies, blood samples, tissues and organs. Read more information about relevant material.
Our guidance document provides information about the consent and licensing requirements for removing samples from the deceased for testing or analysis:
You must have consent from an appropriate person (or coronial or police authority) to obtain a sample from the body of a deceased person, and to store and use the sample for a scheduled purpose.
The HT Act sets out who may give consent – our guidance document provides further information about this.
Where consent or authority from an appropriate person has not been given, the activities cannot proceed.
You must only remove a sample from the body of a deceased person (for a scheduled purpose) on premises that are licensed by the HTA, unless it is authorised by the police.
HTA licences are premises specific. Licences for removing samples from the deceased for testing are for a fixed term of 12 months. The relevant licence must be in place before the activity is undertaken.
Contact us for information on licensing fees.
As part of the licence application, we require documented risk assessments of the licensed activities planned to be undertaken at the establishment. These can be in any appropriate format. We have produced an example risk assessment template to assist establishments with documenting risk assessments of proposed licensed activities, which you can find below.
There is a statutory duty to notify the proper officer (usually the local Health Protection Team) of certain infectious diseases. Information about this is available online.
Refer to the HTA guidance below for further information about the consent and licensing requirements for this activity and how to apply for an HTA licence.