HTA Licence Exemptions
The two Research Licences held by Cardiff University allow for the removal, storage, use and disposal of human tissue for the purposes of research. All research projects that come under a Licence must adhere to the regulations set out by the HTA.
There are several exemptions from the Licence and these are detailed below.
Please note: All human tissue considered relevant under the Human Tissue Act MUST be held according to HTA Standards, whether or not the material is held under the HTA Licence, and must be notified to the relevant PD and Human Tissue Act Compliance Team.
If a specific research project has REC/NRES approval there is no need for it to come under the HTA Licence. However if the tissue is to be retained following the end date of the ethics approval, it then has to be stored under the University’s HTA Licence and the PI must adhere to the standards and requirements set out by the HTA. As such it is advisable that all projects with NRES approval adhere to the processes detailed in the Quality Manual.
Research tissue banks still need to be held on HTA Licensed premises, even if REC approval is in place.
Note: Ethical approval from School committees within the University does not constitute NRES approval and therefore any projects with University ethical approval will come under the licence and will need to comply with the regulations set out by the HTA. Please notify the Human Tissue Act Compliance Team of any such projects.
Tissue from Tissue Bank with Generic REC Approval
If the tissue comes from a REC-approved, and HTA Licensed, tissue bank with generic ethical approval, the recipients of the tissue do not need to store it under an HTA licence during the period of the research project, subject to certain requirements. If the research is not carried out in accordance with these requirements, specific project approval by a recognised research ethics committee will be required or, alternatively, the samples will need to be stored under an HTA licence. At the end of the project any residual tissue must be returned to the tissue bank or be disposed of. If the researcher wishes to retain the tissue they must apply for their own NRES ethical approval or store the tissue under the HTA Licence.
Note: If the tissue bank stores the tissue on HTA-licensed premises but does not have generic REC approval, each recipient must hold the tissue under an HTA Licence or apply for their own specific project approval by a REC.
Storage is Incidental to Transportation
Under the HT Act, where human tissue is in storage pending transfer elsewhere, providing it is held for a matter of hours or days and certainly no longer than a week, the HTA takes the view that the storage is incidental to transportation and an HTA licence is not required.
Intention to Extract DNA/RNA
Where human tissue is being held whilst it is processed with the intention to extract DNA or RNA, or other subcellular components that are not relevant material (i.e. rendering the tissue acellular), the HTA views this is analogous to the incidental to transportation exception. A Licence is not therefore required, providing the processing takes a matter of hours or days and certainly no longer than a week.
Note: Where a researcher holds tissue for a short period for the purpose of a project (e.g. to conduct analysis prior to discarding the tissue), and the tissue is not rendered acellular this is storage for a scheduled purpose (i.e. research). Such storage requires either a licence from the HTA or REC ethical approval for the project.
For the purpose of research that does not involve any application of tissues or cells into humans, material that is created outside the human body does not fall under the remit of the HTA.
Note: Cell cultures are relevant material if they contain cells that were created inside the human body e.g. if the culture contains original cells from a biopsy or blood sample. Once cells in culture have undergone one full cell-division cycle, the culture no longer contains original cells and the tissue does not have to be held under HTA Licence.
The HT Act only applies to tissue that contains human cells; once the tissue has been rendered acellular it is no longer classified as relevant material and does not comes under the HT Act.
Deceased for More Than 100 Years
If the tissue comes from someone who has been deceased for more than 100 years, it does not need to be held under an HTA Licence.