NIBSC - Human Tissue License

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Human Tissue License

Human Tissue Licence

NIBSC holds a Human Tissue Authority License (Number 12321), issued by the Human Tissue Authority (HTA) that allows them to store relevant material that has come from the Human Body for use for the following scheduled purposes:

Establishing after a person’s death the efficacy of any drug or other treatment administered to him
Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person)
Public display
Research in connection with disorders, or the functioning, of the human body.
Clinical audit
Education or training relating to human health
Performance assessment
Public health monitoring
Quality assurance

In addition the UK Stem Cell Bank (UKSCB) which is part of NIBSC holds a separate Human Tissue Authority Licence – Human Application (Number 22502) which allows for the processing, testing, storage, distribution & import / export of human tissue and cells for human application; and the storage of relevant material which has come from a human body for use for a Scheduled Purpose). This includes the use of cell lines grown outside the human body for patient treatment.

Designated Individual

The HTA require a nominated individual to be responsible for implementing the requirements of the Human Tissue Act and this is carried out by the Designated Individual (DI). The DI have the primary (legal) responsibility under Section 18 of the HT Act to secure:

that suitable practices are used in undertaking the licensed activity
that the other persons who work under the licence are suitable
that the conditions of the licence are complied with.

Please contact Dr Stephen Inglis, who is the Designated Individual for NIBSC, if you have any queries or feedback about how NIBSC complies with the Human Tissue Act via the following e-mail address and title it HTA enquiry:

Email enquires@nibsc.hpa.org.uk

The Human Tissue Act (HT Act)

The Human Tissue Act regulates the removal, storage and use of human tissue - defined as material that has come from a human body and consists of, or includes, human cells. It will be unlawful to carry out these licensable activities without a licence.

The HT Act sets out a new legal framework for the storage and use of tissue from the living and for the removal, storage and use of tissue and organs from the dead. This includes 'residual' tissue following clinical and diagnostic procedures.

Complying with the Human Tissue Act

NIBSC is licensed by the Human Tissue Authority (HTA) (Licence number 12321) to store human tissues for a limited range of specific purposes (known as scheduled purposes). Further information about the Human Tissue Act may be obtained from their website at http://www.hta.gov.uk/.

Obtaining consent to remove, store and use human tissues for specific purposes is one of the underlying principles of the Human Tissue Act and any samples of human tissue stored by NIBSC comply with this requirement of the act. When tissue samples are received at the NIBSC they are retained securely and confidentiality is maintained in compliance with Caldicott principles as are all samples received at this centre. It is normal practice for human tissue samples to be disposed of in the same way that all others clinical samples we receive at NIBSC and we will adhere to any specific requirements regarding disposal of the human tissue samples.