Research that involves the storage, collection, use and/or import of human tissue requires an ethical review by a NHS Research Ethics Committee (NHS REC). This includes research involving healthy volunteers on non-NHS premises. University ethics committees are not recognised under the Human Tissue Act. All such research should be logged with us by completion of the Research Registration Checklist (MS Forms).
A specific study involving human tissue that is taking place in the NHS will need to apply for HRA and HCRW Approval (which will include NHS ethical review) and seek confirmation of capacity and capability from participating NHS organisations in England and Wales (or permission from NHS organisations in Scotland and Northern Ireland).
A specific study involving human tissue that is taking place at non-NHS sites will need to apply for NHS ethical review.
All application are made via the Integrated Research Application System (IRAS). We will review your application before submission to offer sponsorship, conditional on approvals, and provide support and guidance for your submission. Please complete our Research Registration Checklist (Microsoft Forms) to tell us about your study. Your application will also need to be reviewed by the Insurance Office prior to submission and an insurance certificate will be issued. Please contact all parties as early as possible so that we can help you effectively.
If your research involves the procurement of material and subsequent transplantation then a HTA Procurement Licence might be required and you must contact the Research and Human Tissue Manager, Rachel.Davies@bristol.ac.uk, as early as possible.
A Research Tissue Bank (RTB) is ‘a collection of human tissue or other biological material, which is stored for potential research use' (NRES SOP, v6.1, January 2015).
If you are interested in setting up a RTB please email the Research and Human Tissue Manager, Rachel.Davies@bristol.ac.uk, who will be able to guide you through this process.
If you plan to obtain human tissue from a RTB, you should check the ethical arrangements of the RTB to determine whether:
Please email Rachel.Davies@bristol.ac.uk to let us know about your study.
If you have been presented with a research related agreement for signature please contact email: red-contracts@bristol.ac.uk.
Human tissue samples received from outside of England, Wales and Northern Ireland are considered an import. Storage of imported samples for research is a licensable activity under the Human Tissue Act and will either need to be stored under a Human Tissue Authority licence or favourable opinion from a NHS REC (preferred option). Imported material should be procured, used, handled, stored, transported and disposed of in accordance with the consent given by the person from whom it came. Further guidance can be obtained from the Codes of Practice issued by the Human Tissue Authority.
If you do not want to dispose of the samples collected during your specific study when the ethical approval expires, there are a number of options available:
Please contact Rachel.Davies@bristol.ac.uk for advice on all of the above options.
Disposal of samples should be in accordance with the Human Tissue Act and as described in the ethics application. Please see the University's sustainability information.
