Human Tissue Working Group terms of reference

The storage and use of human tissue for research, education and anatomical examination are scheduled activities specified in the Human Tissue Act 2004 (HT Act) and must be licensed by the Human Tissue Authority (HTA). For the purposes of the HT Act, the University is the Licence Holder (LH) and each licence has a named Designated Individual (DI) who is legally responsible for ensuring compliance with the HT Act.

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 HTWG meets not less than three times a year and a member of the Research Governance Team (RGT) in the Division of Research, Enterprise and Innovation provides administrative support to the HTWG. The HTWG reports to the University Ethics of Research Committee (UERC).

Members (voting):

Invited attendees (non-voting):

There will be no quorum but the Chair may adjourn any meeting where it is considered that there are too few members present for meaningful discussion of agenda items. In the absence of the Chair another DI or the Research Governance Team will chair the meeting.

Chairmanship of the HTWG will be on the nomination of the Group, initially for a three-year term. Normally the Chair will be a DI or a senior member of the University management. The Chair may serve successive terms of office with the approval of the HTWG.

The Chair will support the LH and the Research Governance team with expertise to help them ensure compliance of the University with the HT Act. The role holder will act as the tissue storage expert for the internal audit programme, the risk review, incident and adverse event management and the review of the University Code of Practice.

The Chair will approve and present the HTWG annual report to the UERC with the support of the Research Governance Team.

The HTWG will:

Appendix: The role of the LH

The LH has institutional responsibility for the HTA Licences. Oversight of the activity is provided by the UERC (a joint committee of the Board of Trustees and Senate). Operational support is provided by the RGT in Division of Research, Enterprise and Innovation, the Secretary’s Office (legal advice) and the HTWG.

Read HTA guidance.

The LH will: