The Human Tissue Act 2004 (HT Act) established the Human Tissue Authority (HTA) to regulate activities concerning the removal, storage, use and disposal of human tissue.
It covers both consent and licensing, making consent fundamental to the removal, storage and use of human tissue for scheduled purposes.
Salford Royal NHS Foundation Trust holds a HT Act Research Licence with a named Designated Individual (DI) who is responsible for supervising the licensable activities. The DI must be made aware of any activities that are undertaken at the main Salford Royal site, and need to be covered by the licence.
The Act provides full guidance on what defines relevant material but in general it relates to biological samples that contain one or more cells from a human body.
The HTA issued updated Codes of Practice in April 2017 which help provide practical advice and interpretation of the legislation. The main Codes relating to the research licence held at Salford Royal are:
- Code A: Guiding Principles and the fundamental principle of consent
- Code E: Research and Standards
The codes are supplemented by other more detailed guidance, for example on licensing standards, which can be found on the HTA’s website. Some circumstances exist that can allow tissue to be held on the premises without a licence.
Salford Royal has a responsibility to ensure that all relevant material is handled appropriately and would encourage anyone with queries relating to their samples or research to contact the DI for advice.
The Designated Individual (DI) for Salford Royal is Dr Rob Oliver.
Alternatively you can contact the HTA directly with queries or concerns.