You work under a licence if you work with one or more samples registered under an HTA licence.
If you work only with samples exempt from licensing (even if these are stored or used on licensed premises), then you do not work under an HTA licence.
In the case of biobank samples, all staff working on samples stored in research tissue banks are considered as working under an HTA licence, but staff members in research teams who handle samples released from research tissue banks for a particular approved research project do not work under an HTA licence.
The custodian of the samples (chief investigator) can confirm whether or not the collection is licensed. If you are really unsure whether you work under an HTA licence, please contact us.
More than 2,000 staff in the Medical Sciences Division work with human tissue. They must all be aware of regulations in this field and complete training on the Human Tissue Act 2004, updating it every two years.
They include (but are not limited to):
- lab staff who physically handle tissue samples
- clinical staff who seek consent for collection of samples
- anyone who is involved in applying for ethical approval to collect or use material
- the PIs/CIs responsible for groups working with human tissue
All are considered to be working with human tissue although they do not all work under an HTA licence. The Human Tissue Act 2004 applies to everyone, even though the licensing requirements do not.