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 Division provides administrative support to the HTWG. The HTWG reports to the University Ethics of Research Committee (UERC).

Members (voting):

• Licence Holder’s Representative or delegated attendee (role of LH detailed in Appendix)
• All Designated Individuals under University-held HTA licences or delegated attendee
• Biological Safety Officer
• Head of Research Governance
• Research and Human Tissue Manager

Invited attendees (non-voting):

• Representative from Sustainability
• Representative from local NHS Trusts
• Representative from the University of the West of England

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, 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 Head of Research Governance.

The HTWG will:

• provide expert advice in relation to the use of human tissue at the University;
• advise on the development of policies and procedures to ensure institutional compliance with the requirements of the HT Act, including the provision of guidance through a code of practice. This will be reviewed at least bi-annually and, where necessary, revised for implementation by the University via appropriate processes;
• disseminate to the HTWG and, as necessary, within the University, national and local information in relation to human tissue, for example, HTA or Health Research Authority communications and regulatory alerts;
• guide the internal auditing of University licences, including review of audit reports (for the sharing of best practice and expertise) and the making of recommendations to the LH, the relevant DI, other DIs, Deans and Heads of School, and the UERC;
• advise on the need for new licences, for licence variations and for consolidating tissue storage in order to manage effectively the number of licences held by the University;
• provide advice to the RGT, DIs and/or LH in respect of studies that are not conducted under Licence exemption e.g. with a favourable opinion from a NHS Research Ethics Committee and where these are conducted under Licence with the explicit agreement of the DI;
• receive reports of incidents and adverse events for the purpose of sharing best practice in relation to the use of human tissue in the University and highlighting University wide issues for consideration by the LH;
• at least annually, review risk evaluations carried out by each DI in relation to the Licences they administer and escalate any changes in identified risks to the PVC-Research via the HTA Licence Holder representative;
• approve the annual report prior to presentation to the UERC with the aim of providing assurance to the UERC.

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 Division, the Secretary’s Office and the HTWG.

Read HTA guidance (PDF, 101kB)

The LH will:

• attend or identify a nominee for the HTWG;
• represent the University in HTA inspections;
• receive internal audit reports;
• receive exception reporting in relation to incidents or adverse events from the HTWG via the Head of Research Governance;
• will approve the annual report to the UERC;
• will issue direction to ensure and improve compliance based on guidance and advice received from the HTWG via the Head of Research Governance.