Arrangements for Complying with The Human Tissue Act 2004
About the Act
The Human Tissue Act 2004 (HT Act) repealed and replaced the Human Tissue Act 1961, the Anatomy Act 1984 and the Human Organ Transplants Act 1989 (in England and Wales). The Act makes it unlawful to remove, store or use human tissue from the living or deceased without consent to do so for specified health-related purposes or public display and is punishable by a fine and/or 3 years imprisonment. There are also a number of activities in the Act that require a license from the Human Tissue Authority before they can be lawfully undertaken.
The Human Tissue Authority (HTA) was set up to regulate the removal, storage, use and disposal of human bodies, organs and tissue for a number of Scheduled Purposes (such as research, transplantation, and education and training) set out in the HT Act. In order to carry out research that leads to the human benefit and for teaching purposes the University of Bristol uses and stores tissue that falls within the remit of the HTA. The University therefore has obligations under the HT Act.
Further information is available from our key facts page and the Human Tissue Authority website, including information on what needs licensing, and codes of practice on use of tissue and on appropriate consent.
License arrangements at the University of Bristol
The corporate license holder for all licenses is the University of Bristol. The University Deputy Secretary is the corporate point of contact for the Regulator and other interested parties and all licences must be submitted under the Deputy Secretary's authority. The University has established the Human Tissue Working Group to oversee the development of a university code of practice, the licensing process and auditing of licensed activities.
Human Tissue Working Group
Meeting Minutes
- Chaired by Prof. John Armitage, Director and DI, Bristol Eye Tissue Bank
- Dean of Medical & Veterinary Sciences
- University Deputy Secretary
- Head of Research Governance, RED
- Designated Individuals
- University Biological Safety Officer
- Representative from the Department of Archaeology & Anthropology
- Sustainability Manager (Waste and EMS)
If you did not declare your holding of human tissue at the time of the 2006 audit, undertaken by the Human Tissue Working Group, it is vital that you contact the Chair of the Working Group immediately.
The Working Group has developed an internal audit programme and a code of practice for working with human tissue.
Health and Safety Requirements
When working with human tissue it is necessary to consider the types of pathogens that may be present in the material taking into account the distribution of specific pathogens within the body, and the likelihood that they will be present given the source (be it a donor, patient group, or general population). A risk assessment of the proposed work with human tissue must be undertaken and depending on the risks identified approval from the Biological and Genetic Modification Safety Committee may be required before work can commence. Please take a look at the Biological Safety webpages for further guidance on procedures, appropriate precautions and risk assessment forms. The University Biological Safety Officer may also be contacted for further advice on health and safety requirements.
HTA Regulatory Alerts
Regulatory alerts received by the Licence Holder from the Human Tissue Authority will be sent to the Research Governance Manager who will circulate to all DIs. These alerts can be found on the Human Tissue Authority webpages.
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