University arrangements

License arrangements at the University of Bristol

The University of Bristol is the corporate license holder for all licences in the University. The PVC Health is the corporate point of contact for the Human Tissue Authority and other interested parties. The University has established the Human Tissue Working Group to oversee the University Code of Practice, the licencing process and auditing of licenced activities.

Premises where tissue collections are stored will be licenced, not the collections themselves. All collections stored at these premises must be collected and held in accordance with the quality manual for that licence, even when they are stored for third parties.

A separate licence will be required for each site with a different address (defined as the post code), and for sites at the same address that are not under the same governance and operational control.

Human Tissue Working Group

The Human Tissue Working Group was established as an expert advisory group to share best practice in all aspects of the HTA licensing requirements. In addition it functions as a forum for Human Tissue Act related consultations on behalf of the University. The Working Group meets not less than four times a year. The terms of reference and membership of the Working Group are available.

The Working Group has developed an internal audit programme, Code of Practice for working with human tissue and Disposal Policy.

Minutes are available for internal access.

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 refer to 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 Head of Research Governance who will circulate to all DIs. These alerts can be found on the Human Tissue Authority website.

Licence exemptions

According to the latest guidance from the HTA, tissue stored for research purposes is exempt from the licencing requirement if the tissue is:

However, consent is the fundamental principle of the Human Tissue Act and must be obtained for the removal, storage and use of human tissue for certain scheduled purposes, including research (unless a consent exemption applies).