Working with the Human Tissue in the NDMRB
The Human Tissue Authority (HTA) was set up to regulate the removal, storage, use and disposal of human bodies, organs and tissue for a number of Scheduled Purposes - such as research, transplantation, and education and training - set out in the Human Tissue Act 2004 (HT Act). The HT Act covers England, Wales and Northern Ireland and came into force on 1 September 2006.
The NDMRB is currently registered under HTA licence number 12217. This satellite licence covers the storage of human tissue for research purposes under the Act.
The NDMRB management policy is to ensure compliance with the Human Tissue Act and with the standards and guidance set by the Human Tissue Authority. The level of quality required is achieved through adoption of a system of procedures that reflect the regulatory standards and guidelines and the documents contained within this webpage.
All staff who work with human tissue are involved in achieving compliance with these procedures and are individually responsible for the quality of their work, which should result in a continually improving working environment for all.
The NDMRB Person Designated (PD) acts as a local representative for the Human Tissue Authority. The NDMRB PD is to liaise closely with the Designated Individual (DI), Brian Shine, who is responsible for implementing the requirements of the Human Tissue Act. Together they are the people under whose supervision the licensed activity is authorised to be carried out. They have the primary (legal) responsibility under Section 18 of the Human Tissue Act to secure:
- that suitable practices are used in undertaking the licensed activity;
- that other persons working under the licence are suitable and;
- that the conditions of the licence are complied with.
For any queries relating to licensable activities under the HTA, please contact the NDMRB Person Designated: Jane McKeating