Human Tissue Act 2004

Background

The Human Tissue Act 2004 (HT Act) came in to force on 1 September 2006.  The aim of the HT Act is to provide a legal framework regulating the storage and use of human tissue from the living and the removal, storage and use of tissue from the deceased. 

The Human Tissue Authority (HTA) is the governing body set up to regulate activities that come under the HT Act. The HTA is a watchdog that supports public confidence by licensing organisations that store and use human tissue for purposes such as research, patient treatment, post-mortem examination, teaching, and public exhibitions. The HTA have developed nine Codes of Practice, which provide guidance and lay down expected standards for each of the sectors regulated. A link to the HTA Codes of Practice can be found at the top right of this page. 

In order to comply with the HT Act, all establishments that store or use human tissue have to be licensed. A Designated Individual (DI) is appointed to each licence and they are legally responsible for ensuring compliance with the conditions of the licence, with assistance from a number of Persons Designated (PD). The PDs are appointed from Schools storing human tissue and act at a local level to support the DI in providing advice about the procedures and systems that ensure compliance with the HT Act and the terms of the University's Licence. A governance structure listing the University staff involved in the two HTA Licences can be downloaded at the top right of this page.

Research Licences

The University has been granted two research licences, which cover Cathays Park [Licence No. 12457] and Heath Park [Licence No. 12422]. The latter is held jointly with the Cardiff & Vale University Health Board. Any research projects that involve human tissue at either of these locations will be covered by the existing Licence. However all projects that come under the Licence will need to comply with the terms of the Licence. A copy of each of the Licences can be downloaded from the top right of this page.

Each Licence authorises the storage of relevant material for the following scheduled purposes:

• Determining the cause of death
• Establishing after a person’s death the efficacy of any drug or other treatment administered to him
• Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person)
• Public display
• Research in connection with disorders, or the functioning of the human body
• Clinical audit
• Education or training relating to human health
• Performance assessment
• Public health monitoring
• Quality assurance

Other Licences

The University also holds an Anatomy Licence [Licence No. 12065] for which Professor Bernard Moxham is the Designated Individual.