Human Tissue Act training

The Human Tissue Authority requires 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.
  • Training should be documented, kept up to date and competency assessed and maintained. The training requirements extend to visiting staff and should be documented in induction programmes for new staff.
  • Staff involved in seeking consent are expected to undertake training and be given support in the essential requirements of taking consent. There should be suitable training and support of staff involved in seeking consent, which addresses the requirements of the Human Tissue Act and the HTA’s Codes of Practice.
  • The chief investigator is responsible for making sure all staff are appropriately trained for their role.
  • Training must be updated every two years.
Who does it apply to?

Training must be undertaken by anyone working with human samples (relevant or non-relevant material), whether under HTA licence or under REC approval.

'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 any staff involved in managing ethics approvals for projects involving human samples.

'Human samples' are defined as any cellular or acellular human sample derived inside of 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.

 

Who needs training? What training? Responsible for tracking Is this new? How to access
Everyone working with* human tissue in Medical Sciences Division, including those managing REC submissions, short-term staff and visitors must complete before handling human tissue whether under an HTA licence or REC approval WebLearn training, updated every 2 years CIs are responsible for appropriate, up-to-date training of their staff; HTGT does not track individual staff completion though can grant access to WebLearn for visiting staff Divisional policy since 2017

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or request guest access

Everyone working with* collections licensed under HTA Licence 122217; must be completed before handling material registered under the Licence
 
WebLearn training, updated every 2 years Collection Responsible Officers are responsible for notifying HTGT of new starters working with licensed collections Mandated by HTA for staff working under Licence 12217 since 2017 Use Single Sign-on
Everyone working with* collections licensed under HTA Licence 122217; must be completed before handling material registered under the Licence Read and acknowledge Licence core SOPs on iPassport HTGT tracks this;
Collection Responsible Officers are responsible for notifying HTGT of new starters working with licensed collections
Mandated by HTA for staff working under License since 2017 Collection Responsible Officer provides names and email addresses of staff to HTGT, who create iPassport accounts.  Login details are sent to staff via email.
Staff seeking consent from donors (including healthy volunteers, staff, students) for research Good Clinical Practice, updated every 3 years with competency assessed (medics, NHS staff undergo equivalent mandatory training) CIs are responsible for appropriate, up-to-date training of their staff
 
required by law for CTIMPs; UK Policy Framework for Health & Social Care Research requires documented training for consent seekers

CTRG provides GCP training options

 

*”working with” includes all staff who seek consent, manage Ethics approvals, or handle samples in lab, whether as short-term visitors or University staff.
CROs are also required to inform HTGT of leavers, so that iPassport accounts can be inactivated.
Newly registered collections under Licence 12217 will be under quarantine if PI and CRO have not completed mandatory training.
Training certificates are sent automatically to staff via email upon completion; HTGT cannot create replacements, nor can they verify the date of completion.

Online training

Training on the Human Tissue Act 2004, the Human Tissue Authority (HTA) and the HTA Codes of Practice is provided online:

HTA training

 

 

List of site pages