The University of Bristol is the corporate license holder for all licences in the University. The Registrar and University Secretary 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.
The Human Tissue Working Group (HTWG) was established as an expert advisory group to share best practice in all aspects of the HTA licensing requirements and general HT Act compliance across the University. The HTWG supports compliance with the HTA licensing standards by facilitating annual internal audits of each licence, in readiness for HTA inspections. In addition, it functions as a forum for HT Act related consultations on behalf of the University.
The Working Group meets not less than three times a year. Read terms of reference and membership of the Working Group.
The Working Group has developed:
Read minutes (internal access only)
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 University's Biological Safety information 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.
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.
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).
