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 issues licences to 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. 

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 HTA Licences. The Human Tissue Act Compliance Team, based in Governance and Compliance Division, ensures University-wide compliance with the HTA Licence and offers advice and training to researchers working with human tissue. Contact information for the DI, PDs and Human Tissue Act Compliance Team can be found at the top right of this page.

Research Licences

The University has been granted one Hub and one Satellite Research Licence by the HTA: the Hub (Licence No. 12422) covers research projects from both Cardiff University and Cardiff and Vale UHB on the Heath Park site; and the Satellite (also Licence No. 12422) covers the Cathays Campus. A governance structure for each licence can be downloaded at the top right of this page. All research projects that involve human tissue at either of these locations will potentially be covered by one of the existing licences, subject to a satisfactory demonstration of compliance with HTA requirements. 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 Dr Tracey Wilkinson is the Designated Individual and a Human Application Licence (Licence No. 22639) for which Professor Steve Dunnett is the Designated Individual.