Human Tissue Working Group terms of reference

The storage and use of human tissue for research, education and human application 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. 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 Research and Enterprise Development 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 Head of Research Governance 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 Head of Research Governance 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, Serious 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 Head of Research Governance. 

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 Research and Enterprise Development, the Secretary’s Office and the HTWG. 

HTA guidance: https://www.hta.gov.uk/sites/default/files/2006-03-01_Guide_to_licensing_for_DIs_and_LHs_final_PDF.pdf 

The LH will: