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University's HTA Licence

The University holds a licence from the HTA for research (Licence number 12297).

The University is licensed to store human tissue (Relevant Material) at the following sites (Licensed Premises):

 

Hub site:
Clinical Sciences Research Laboratories
Warwick Medical School
University of Warwick
University Hospitals Coventry and Warwickshire NHS Trust
Clifford Bridge Road
Coventry
CV2 2DX
   
Satellite site: Department of Life Sciences
University of Warwick
Gibbet Hill
Coventry

CV4 7A

   
Licence Holder: University Registrar
   
Designated Individual: John Davey, Professor of Biomedical Cell Biology
Warwick Medical School
   
Deputy Designated Individual: TBC
   
Person Designated Cathy Parry
   
Person Designated

Rebecca Allen


The licence authorises the storage of relevant material that has come from a human body for use for the following scheduled purposes:

  • Determining the cause of death;
  • Establishing after a person’s death the efficacy of any drug or other treatment administered to him/her;
  • Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person);
  • Public display;
  • Research in connection with disorders, or the functioning, of the human body;
  • Clinical audit;
  • Education or training relating to human health;
  • Performance assessment;
  • Public health monitoring;
  • Quality assurance.

The licensed activity should be carried out only at the licensed premises specified above, and under the supervision of the Designated Individual. A copy of the licence is displayed at each site i.e. at the licensed premises.

HTA Inspection, July 2010

In July 2010, the University underwent a Phase 2 inspection by the HTA. Over two days, HTA officials inspected the University’s HTA licensed premises, procedures, documentation and key individuals at the CSRL and at Gibbet Hill.

Overall, the inspection went well. It was recognised that a good governance system for the licence is in place, with a very good quality manual and proportionate set of standard operating procedures (SOPs), following a full overhaul of current policies and procedures under the licence undertaken since September 2009. The final Inspection Report was received on 12 October 2010.

A condition was placed on the licence to ensure that all aspects of the draft quality manual, SOPs and planned training programmes are fully implemented by 1 March 2011. As a result of further work following the inspection, prior to the receipt of the final report, the HTA have acknowledged that this condition has now been met. The condition on the licence will now be recorded as “proposed but not applied” by the HTA.

Six other items of advice and guidance were also recommended by the inspectors which are currently being progressed by the University’s Designated Individual under the licence, Professor John Davey, with support from the Human Samples Steering Group, to ensure the University’s full compliance. The full report will be considered at the next meeting of the University Audit Committee.