Information for Researchers
Compliance with the HTA Licence is relatively straightforward and the standards and procedures required would generally be considered good research practice. The HTA view human tissue as a very valuable resource and want to ensure its use/storage has been consented to and the tissue is looked after. A number of documents have been written by the Human Tissue Act Compliance Team and approved by the Cardiff University HTA Working Group for use in research involving human tissue (see below). For further advice on any of these documents please contact the Human Tissue Act Compliance Team using the contact information provided at the top right of this page.
Quality Manual and Standard Operating Procedures
A Cardiff University HTA Quality Manual has been developed to ensure compliance with the HT Act and the standards and guidance set by the HTA. The Quality Manual must be read by all staff and students working on research projects involving human tissue.
The Cardiff University HTA Standard Operating Procedures (SOPs) have been drafted to ensure that all research projects comply with the requirements of the HTA Licence. These SOPs must be followed by all staff and students working on research projects involving human tissue.
The most up-to-date versions of the Quality Manual and SOPs can be found below:
The HTA consider all tissue that was created inside a human body, other than gametes and nail/hair from the living, and contains at least one cell to be relevant material. Bodily fluids that are likely to contain cells are considered to be relevant material, e.g. blood, urine, saliva. Human tissue that has been rendered acellular is not considered to be relevant material under the HT Act.
A copy of the HTA’s list of relevant materials can be downloaded from the top right of this page.
The researcher should ensure that valid and appropriate informed consent has been taken for the removal, storage and use of the human tissue. Ideally copies of consent forms should be available. However, if consent is taken elsewhere, a document will need to be produced from the supplier stating that consent is in place for all the tissue supplied. If consent is being taken by staff on the research project, they should have received appropriate consent training. A record of the training received should be maintained. An online module (Human Ethics 2) that covers consent training is available through the Staff Development Programme, follow the internal link at the top right of this page.
Further information on consent can be found here and in the University’s SOP for Informed Consent.
Human tissue should be stored safely and securely following the guidance in the University’s SOP for Storage. Tissue should be kept in a locked room with controlled access; ideally, fridges/freezers/cupboards should also be locked. Areas where human tissue is stored should be clearly marked as such and, if held under the HTA Licence, a copy of the HTA Licence should be displayed. Thought should be given to how to deal with fridge/freezer failure outside of office hours or if the storage location is not frequently accessed/supervised. An alarm system would be useful.
Maintenance and cleaning of storage facilities should be scheduled regularly and records kept in accordance with the University’s SOP for Maintenance.
If material is to be transported outside of the research project (even between Cathays and Heath Park campuses) records of such movements should be kept and logged in the traceability record.
A Material Transfer Agreement (MTA) must be in place for all incoming and outgoing tissue transfers. An MTA should define how the human tissue will be preserved, any potential contamination risks associated with it and who will be responsible for disposal if applicable. For incoming tissue, the supplier will usually provide the MTA. For outgoing transfers, the University or UHB will provide the MTA. MTAs must not be signed by individual researchers and must go through either Cardiff University Research and Commercial Division or the UHB R&D Office. For more information see the University’s SOP on Transportation.
Human tissue should be disposed of in a respectful manner and in accordance with the procedure detailed in the University’s SOP for Disposal. Records of disposal should be kept. If the sample is completely used up during processing this needs to be recorded as the method of disposal.
Records must be maintained that provide an audit trail for the traceability of tissue samples from receipt to disposal.
Records of consent, tissue transfer and tissue disposal must be kept for 7 years after the transfer or destruction of the human tissue as an audit trail to demonstrate that the transfer or destruction complied with HT Act and with the conditions of consent given by the donor.
Further information on Tissue Traceability can be found here and in the University’s SOP for Management of Records.
Risk assessments for all procedures should be carried out and documented, not just from the perspective of risk to persons, but also the risk to the tissue. Contingency plans need to be drafted to cope with adverse events such as fridge/freezer failure, the possibility of contamination, and risks posed during transportation of material.
Further information on Risk Assessments can be found here and in the University’s SOP for Risk Management.
All members of staff/students holding tissue under one of the HTA Licences must have received training in the HT Act. It is recommended that anyone using human tissue for research purposes obtains training in the HT Act, even if their project is exempt from the Licence. Training is provided by Cardiff University and can be found in the Staff Development Programme; one off training sessions can be arranged for small groups. The MRC also offer on-line training in the HT Act. Training completion certificates must be retained.
Anyone who is taking consent needs to be trained to do so. Training in Informed Consent is available to University and UHB staff through the Good Clinical Practice (GCP) course provided by UHB and Research and Commercial Division, and the online module, Human Ethics 2, available through Cardiff University.
Links to these training courses can be found at the top right of this page.
Internal audits of Schools/research projects are undertaken to confirm that the area concerned is adhering to the University's Procedures and is compliant with HTA requirements and regulations.
Further information on internal audits can be found here and in the University's SOP for Internal Audit.
There are a number of exemptions to the HTA Licence, more information can be found here . Please note that even if a project is exempt from the licence, it is not necessarily exempt from consent.