‘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.
Training requirements for the Human Tissue Act 2004
Details of mandatory training for work with human samples
Anyone who works in the Medical Sciences Division with human samples (relevant or non-relevant material) in research, whether under a Human Tissue Authority (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 (MSD) through the MSD Human Tissue Policy and builds upon the HTA’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 MSD are required by the designated individual for the licence to complete HTA training.
- Training must be included in induction programmes for new staff, be documented, kept up-to-date, and competency assessed and maintained – including short-term, visiting staff and students
- Training must be completed before starting work with human samples and updated every two years
- The chief or principal investigator is responsible for ensuring that they, all their staff, and any students in their research group are appropriately trained for their role and that proof of completion is available for auditing purposes. To check arrangements for individual HTA licences and departments contact your person designated or departmental contact.
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.
Definitions
‘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.
Human Tissue Act training
Training is delivered online through the UKRI's Medical Research Council’s Regulatory Support Centre e-learning system.
If you are involved in research on human samples, whether 'relevant' or 'non-relevant', follow these steps:
You must complete:
- the Research and Human Tissue Legislation online module
- the Research and Human Tissue Legislation Assessment – England, Wales and Northern Ireland online module
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.
You will need to create a user account. Use Firefox, Chrome, IE or Edge with Javascript, Adobe Flash and pop-ups enabled. If you have technical problems with the site contact the MRC’s Regulatory Support Centre.
You do not need to undertake further training in relation to the Human Tissue Act. 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 hta_help@admin.ox.ac.uk for advice, and revisit this page if your circumstances change.
Consent training
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 RGEA. 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.
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