Under the Human Tissue Act 2004 (HT Act 2004) studies involving relevant material must be stored on a licensed premises unless ethical approval has been granted by a ‘recognised’ ethics committee. University ethics committees are not ‘recognised’ ethics committees and so researchers will usually need to apply to an NHS ethics committee via the IRAS system. Researchers seeking to access samples from a Biobank that has been granted generic ethical approval, provided the study meets their conditions of approval, the study will be considered to have ethical approval.
The Code of practice 9: Research has helpful guidance on when ‘recognised’ ethical approval is required as well as flowcharts showing when consent and licensing are required.
Researchers storing samples under a human tissue license do not need to apply to a ‘recognised’ ethics committee for ethical approval. However, UCL researchers will still require ethical approval for the research and therefore will need to apply to the UCL Research Ethics Committee (or UCL Institute of Education Research Ethics Committee). This is because at UCL all research (unless exempted) requires ethical approval.
Studies involving samples (i.e. serum, DNA etc) that are not classed as relevant material do not need to be stored under a HTA licence. In other words, researchers do not require a HTA storage licence under the HT Act 2004, if their research i) involves acellular material only (i.e. serum or DNA) or ii) if the cellular material (i.e. blood) is rendered acellular immediately and only serum is stored for research.
Studies involving prospective recruitment of participants and collection of relevant material (i.e. blood samples etc.) may need to be approved by a ‘recognised’ ethics committee. Studies that do not involve prospective recruitment and only involve existing acellular material can be ethically approved through the UCL ethics system as mentioned previously.
In summary there are three options for ethical approval depending on your study;
- A ‘recognised’ ethics committee (generally NHS ethical approval) – all studies falling under the remit of the HT Act 2004 (relevant material) unless stored under the governance of a HTA storage license;
- Biobank ethics committee – for studies applying to use samples from a Biobank with generic ethical approval;
- UCL (or IOE) Research Ethics Committee – for all studies that are not covered by ethical approval from a ‘recognised’ ethics committee or Biobank.
Please note that the National Research Ethics Service (NRES) will ethically review studies involving human tissue, even if it does not fall within the definition of ‘relevant material’ under the HT Act 2004.
For information on the nine HTA-licenced Biobanks
within UCL visit the Biobanking at UCL website.