Human Tissue Authority

The regulator for human tissue and organs

Roles and Responsibilities

There are four primary roles under HTA licences. The list below gives a short definition of each role. You can find more details on the responsibilities that come with each role under the sector-specific information.

Designated Individuals (DIs)

  • DIs have a legal duty to ensure that statutory and regulatory requirements are met. They are responsible for supervising licensed activities and ensuring suitable practices are taking place. ¬†An establishment licensed under the HT Act or Q&S Regulations must have a DI.

Named Contacts (ODT sector only)

  • For licences under The Quality and Safety of Organs Intended for Transplantation Regulations 2012, there must be a Named Contact for each clinical area of specialty.

Persons Designated (PDs)

  • PDs assist DIs in ensuring compliance with HTA standards. PDs can assist with developing procedures, as well as reporting incidents. If you have satellite sites, there should be at least one PD for each site.

Licence Holders

  • A licence holder can be an individual or a corporate body. We recommend that a licence holder is a senior manager from a corporate body, acting as the representative on its behalf.

Last updated on: 8 Aug 2019