Facilitating world-class research
Anyone who works in the Medical Sciences Division with human samples (relevant or non-relevant material) in research, whether under an HTA licence or a ‘recognised’ REC approval, must undertake training on the Human Tissue Act and its related codes of practice.
This is mandated by the Medical Sciences Division and builds upon the Human Tissue Authority’s requirement that people working under the governance of an HTA licence are appropriately qualified and trained in techniques relevant to their work and are continuously updating their skills.
Additionally, staff working with HTA licence 12217 collections outside of the Medical Sciences Division, for example in Zoology, are required by the designated individual for the licence to complete HTA training.
If you are using samples under a valid recognised REC approval, it is your responsibility to read and understand the REC application, approval and any amendments. Make a note of the REC number, the title of the study and the expiry date and ensure storage locations are labelled accordingly.
‘Working with human samples’ is defined as being involved with seeking consent for the collection of human tissue samples, collecting, processing, storing, using, releasing or disposing of human tissue samples, as well as chief/principal investigators and any staff involved in managing or writing ethics approvals or standard operating procedures for projects involving human samples. This definition also includes staff named on any study protocol or IRAS form, as well as staff on consent delegation logs.
‘Human samples’ are defined as any cellular or acellular human samples or fluids derived from the human body including, but not limited to, blood or blood derivatives (plasma, serum, buffy coat etc), urine, faeces, saliva, tissue sections (stained or unstained), fresh frozen or fresh tissue samples, fixed samples (formalin, glutaraldehyde etc) and formalin fixed paraffin embedded blocks and slides.
The HTA endorses this definition: a study which addresses clearly defined questions, aims and objectives in order to discover and interpret new information or reach new understanding of the structure, function and disorders of the human body. Research attempts to derive new knowledge and includes studies that aim to generate hypotheses, as well as studies that aim to test them or develop practical applications or new knowledge.
The University's HTA training requirements were updated in Michaelmas term 2019. Training is delivered online through the Medical Research Council’s Regulatory Support Centre.
If you are involved in research on human samples, whether 'relevant' or 'non-relevant', follow these steps:
You must complete:
The pass rate is 70%, and training needs to be completed in one session.
Download and retain your certificate, and update your training every two years.
Visit the iPassport site to:
Contact us if you need help with access to iPassport.
Contact the relevant designated individual for the licence.
Contact us for advice
You do not need to undertake further training. However, make sure you undertake any other regulatory training, and revisit this page if your circumstances change.
If you are not involved in research on human samples, you do not need to undertake HTA training. However, you may need other training if you are involved in other activities with human samples, such as human application, anatomy or teaching. Contact your designated individual or email email@example.com for advice, and revisit this page if your circumstances change.
Staff involved in seeking consent must undertake training and be given support in the essential requirements of taking consent. This is also a legal requirement for clinical trials of an investigational medicinal product (CTIMPs) and under the UK Policy Framework for Health & Social Care Research.
Training in good clinical practice is available from CTRG. Outside the University, courses include in-house training from the MRC Regulatory Support Centre's, NHS consent training for clinicians and NIHR training on informed consent and good clinical practice.
Chief or principal investigators are responsible for ensuring all applicable staff have appropriate and up-to-date consent training (renewed every three years) and that proof of completion is available for auditing purposes.