Designated Individuals have a key role to play in implementing the requirements of the Human Tissue Act. They are the person 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.
The DI might be a head of department, clinician, scientist or manager. What is important is that it is a person who is in a position to ensure that activities are conducted properly, by people who are suitable to carry out those activities, and that all the necessary requirements are complied with.
For those establishments storing tissue under the terms of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) there are further requirements a DI must satisfy to be qualified to take up such a post within such an establishment.
In all cases the Licence Holder must have the prior consent of the DI to make the application. Whilst the DI must be an individual, the HTA has a preference for the licence holder to be a corporate body where possible (e.g. an NHS Trust).
The role of Licence Holder does not impose the duties that are expected of the DI; however, it is important to note that they have the right to apply to the HTA to vary the licence. This enables them to substitute another person as the DI and allows the establishment to cover circumstances where the DI is unable to oversee the licensable activitie(s). Consequently, the HTA prefers individual licence holders to be more senior than the DI (i.e. Medical Director / Chief Executive).
Establishments applying as a corporate body should provide the contact name of an individual who will act as a representative for the corporate body. This individual should also be more senior than the DI in order to substitute the DI where necessary.
The HTA is required to provide all notices of licence decisions to both the LH and the DI.