Ethical approval for project-specific research

In England, Wales and Northern Ireland the storage of tissue for use in research requires a licence from the Human Tissue Authority (HTA), unless the tissue is held for the purpose of a specific project with approval or for which approval is pending from a REC recognised by the United Kingdom Ethics Committee Authority (UKECA) or the Secretary of State e.g. an NHS REC. See HTA FAQ: Research

The majority of UCL-led research projects involving the storage and/or use of relevant material are undertaken with ethics approval. Please note that the UCL REC is not registered with the UKECA therefore if you propose to conduct a research project that will use relevant material from a healthy volunteer you will need to obtain ethical approval from an NHS REC but please note the HTA Code of Practice exemptions relating to University Research Ethics Committees.
Kidney biopsy of a child with Lupus: Dr Stephen Marks, UCL Institute of Health

What should I be aware of if I want to store the tissue I collected as part of an ethics approved research project?

If you plan to store tissue /cells beyond the life of an NHS REC approved specific project for use in further projects you should consider the following points, as well as what the participant consented to regarding the use / storage of the donated sample:

  • Transfer the samples to a HTA licensed research tissue bank (RTB) for further storage or into the holdings of an appropriate Designated Individual who is willing to accept the material under their license or discuss the possibility becoming satellite site with the Designated Individual. See HTA FAQ: Research.
  • Make a further research project-based application to the NHS REC. The application must be submitted no later than the date on which the first project ends. The HTA advise "...an application for ethical approval for the new research project should be made in good time to coincide with the end of the current research project." "The samples will need to be transferred to an existing licensed store until either a licence is granted or ethical approval has been obtained." See HTA FAQ: Research.
  • Set-up a new RTB and apply for a licence from the HTA to store the material. The HTA advise that an "...application for a licence should be made in good time: we recommend at least three months before the current research project ends." Please note that if you propose to apply for a license on UCL premises please inform the Chair of the UCL HTA Governance Committee, Dr Mark Lowdell. Researchers based at the Institute of Child Health or the Institute of Ophthalamology should contact their Joint R&D Offices for advice.

If none of the above steps are taken, arrangements for disposal of the material at the end of the project must be made in accordance with the HTA's Code of Practice: Code of Practice on the Removal, Storage and Disposal of Human Organs and Tissue.

*A project-specific application to the NHS REC cannot be used to seek open-ended approval for use of stored tissue in future research programmes (although the terms of the consent itself may be broad, allowing for future approved research using the same samples). Furthermore, submissions of substantial amendments for approved projects, in order to use tissue for another project with a different set of research questions is not allowed.

What about research using relevant material e.g. blood from healthy volunteers?

As mentioned above, the UCL REC is not registered with the UKECA therefore if you propose to conduct a research project that will take blood from healthy volunteers you should seek ethical approval from an NHS REC - however, the HTA Codes of Practice for Consent and Research (9) notes when ethics approval can be obtained from a University Research Ethics Commitee.