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The country’s largest clinical trial investigating the best gap between first and second Covid-19 vaccine doses for pregnant women, led by St George’s, University of London, is being launched today.
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.
At St George’s, University of London, we currently hold the following licences:
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.
HTA licensing number 12330
Under this licence we have the right to store whole bodies and body parts for anatomical examination, education or training relating to human health, and research in connection with disorders, or the functioning of the human body. St George’s Pathology Museum licence is also held under the anatomy licence.
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.
See appendix A from the HTA (PDF), which is a list of what is considered ‘relevant material’.
Please refer to the following reference documents:
Licensing and consent requirements (PDF)
Guidance on consent (NRES) (PDF)
Research and guidance from the General Medical Council (GMC) (PDF)
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.
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.
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.
Documentation and processes for St George's staff when handling human tissue samples.
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