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The Human Tissue Act 2004 (HT Act) regulates how human tissue is removed, stored and used. The Human Tissue Authority (HTA) is the regulator that sets the standards for safe and ethical use of human tissue samples, enforces compliance, and issues licences for relevant activities under the act.

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Our HTA licences

At St George’s, University of London, we currently hold the following licences:

Research licence: the licence to store

HTA licensing number 12335

Under this licence we have the right to collect, archive and store human tissue samples (relevant material) for the purposes of carrying out research (scheduled purposes) which are carried out under ethical approval from the Research Ethics Service (RES).

The HTA research licence does not license the research process itself. Collection and storage of human tissues can be made under St George’s HTA research licence, but research on those holdings cannot commence until ethical approval is obtained from RES.

Anatomy licence: the licence to educate

HTA licensing number 12330

Under this licence we have the right to store organs and tissues for the purposes of education. St George’s Pathology Museum licence is also held under the anatomy licence.

Documentation

In order to maintain a complete rolling ‘live audit’ of our tissue holdings, and to optimise the use of tissues and organs which are archived and stored under controlled conditions, St George’s has implemented a specific strategy which must be completed before sample collection. See human tissue documentation (login required) for details of those steps and to download the files you’ll need.

Frequently asked questions
What is relevant material?

See appendix A from the HTA (PDF), which is a list of what is considered ‘relevant material’.

Do I need to take consent?

Please refer to the following reference documents:

What do I do if an individual wishes to withdraw their consent?

Ask them to complete a request to withdraw consent form (Word) and explain what will happen to their material and any data already collected. Arrange for any specific disposal requests, but if there are none explain the procedures set out at St George’s.

What should I do in the event of an adverse event or incident?

Firstly, halt the processes or procedures resulting in the adverse event (AE). Secondly, complete an AE/incident form (Word) and email it to the Human Tissue Act designated individual (DI), Dr Penny Lympany. The DI will advise further, following an investigation.

What do I need to do to send human material to other research institutes?

Please fill in a MTA form (Word).

If you have other questions, please address them to the Human Tissue Act designated individual (DI), Dr Penny Lympany, or Ash Sameja.

 

 

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