Regenerative Medicine and the Regulation of Advanced Therapies Medicinal Products (ATMPs)
The procurement and testing of relevant human material, as a starting material for an Advanced Therapies Medicinal Product (ATMP), may require Human Tissue Act licensing (under the Human Application License and NOT the Research License). This is via the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations) and NOT the Human Tissue Act.
The following information on this site relates to the regulation of relevant research activity under the Research License only and is NOT suitable for use with the above Human Application License relevant activities.
Human Tissue Act
The Human Tissue Act is a framework for regulating the storage and use of human organs and tissue from the living, and the removal, storage and use of human organs and tissue from the deceased, for specified health-related purposes and public display.
Human tissue can be defined as material which has come from the human body which consists of, or includes, human cells.
It aims to make consent a fundamental principle underpinning the use and storage of human tissue.
It is overseen by the Human Tissue Authority (HTA), which regulates the removal, storage, use and disposal of human bodies, organs and tissue.
Tissue Transfer Agreements
- The LTHT and University of Leeds Human Tissue Storage and Use Policy
- HTA key facts presentation
- Application to collect tissue for future unspecified research
What licences are held by Leeds Teaching Hospitals NHS Trust and the University?
To comply with the Human Tissue Act, the Leeds Teaching Hospitals NHS Trust (LTHT) and the University work collaboratively and between them hold four of the five HTA licences
- Anatomy: covering specific premises at the University for anatomical examination
- Research: covering specific premises at LTHT and the University (mainly Faculty of Medicine and Health but not exhaustive)
- Therapeutic: covering specific premises at LTHT
- Pathology: covering specific premises at LTHT for post mortem activities
We do not hold a Public Display Licence.
Licensed activities can only take place in the identified locations designated on each licence and under the knowledge and approval of the Designated Individual (DI). Any proposal to change the location must be submitted in writing, by the DI, to the HTA and is subject to HTA approval. Dr Pat Harnden is the DI for the research licence.
Achiever tissue tracking software is used to keep track of the storage and disposal of human tissue relevant under the joint Research Licence from the Human Tissue Authority and for tracking tissue used in projects which have received ethical approval.
The University of Leeds research licence number is 12352.
LTHT/University Human Tissue Act Standard Operating Procedures
LRTB SOP D01 V5.0 HTA Consenting Procedure for LTHT patients. June 2022
LRTB SOP D02 Withdrawal of consent by patients or other donors
LRTB SOP D03 Patient or donor documentation
LRTB SOP D04 Patient donor feedback and complaints
LRTB SOP IT01 V4.0 Patient consent registration. Dec 2021
LRTB SOP IT02 V2.0 Managing Human Tissue Samples in Achiever. Dec 2021
LRTB SOP M01 Data protection and confidentiality
LRTB SOP M02 Document control of Standard operating procedures
LRTB SOP M03 V3 Audit of HTA relevant material Jan23
LRTB SOP M04 HTA Training
LRTB SOP M05 Equipment Use, Maintenance and Failure Contingency
LRTB SOP M06 Disposal of Human Tissue
LRTB SOP M07 HTA Transfer of tissues within and between organisations
LRTB SOP M08 Reporting HTA related adverse events
LRTB SOP M09 Changes to PDs
LRTB SOP M10 Performing HTA Risk Assessments (guidance)
LRTB SOP M10 Performing HTA Risk Assessments (risk assessment form)