Training requirements for the Human Tissue Act 2004

The Medical Sciences Division mandates that training on the Human Tissue Act and its related Codes of Practice must be undertaken by anyone working with human samples (relevant or non-relevant material) in research, whether under an HTA licence or under a ‘recognised’ REC approval.  This 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. Key messages:

  • Training must be included in induction programmes for new staff; be documented; kept up-to-date; and competency assessed and maintained. These requirements extend to short-term and visiting staff as well as students
  • Training must be completed before starting work with human samples and be updated every two years
  • The Chief Investigator/Principal Investigator is responsible for ensuring that they and all their staff and any students in their research group are appropriately trained for their role and that proof of completion (eg a valid certificate) is available for auditing purposes. The Human Tissue Governance Team does not track individual completion of training. Individual HTA licences and departments may have requirements to track training completion (eg departmental collation of training certificates, mandatory declarations etc), please check with your Person Designated / Departmental Contact to find out the local arrangements

A general reminder: 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.

Staff involved in seeking consent must undertake training and be given support in the essential requirements of taking consent. 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 is available from several different sources detailed in this guidance.

Definitions

‘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/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.

Human Tissue Act training

As of Michaelmas Term 2019 the HTA training requirements at the University have been updated. The WebLearn platform has been retired and replaced with an external e-learning module hosted by the Medical Research Council’s Regulatory Support Centre (MRC).  The flowchart below provides additional guidance on the training requirements and next steps to take. In general, there is a requirement for staff to undertake a formal assessment and to obtain and keep a valid certificate, not just undertake the training.

The training is managed by the MRC, if you have any problems with the website then please contact the MRC’s Regulatory Support Centre.

Note: The modules run in Firefox, Chrome, IE, and Edge and the browser must allow Javascript, Adobe Flash, and have pop-ups enabled.

 

TrainingAssesmentWorkExemptIpassportContact1Contact2

HTA licensing at the University of Oxford

Local information on the University of Oxford’s Human Tissue Authority licensing requirements

You work under a licence if you work with one or more samples registered under an HTA licence. If you work only with samples exempt from licensing (even if these are stored or used on licensed premises), then you do not work under an HTA licence. In the case of biobank samples, all staff working on samples stored in research tissue banks are considered as working under an HTA Licence, but staff members in research teams who handle samples released from research tissue banks for a particular approved research project do not work under an HTA Licence.  The custodian of the samples (Chief Investigator) can confirm whether or not the collection is licensed. If you are really unsure whether you work under an HTA Licence, please contact the Human Tissue Governance Team (HTGT).

There are over 2,000 staff in the Medical Sciences Division of the University of Oxford working with human tissue, all of whom need to be aware of regulations surrounding this field of work and to complete mandatory training on the Human Tissue Act 2004, updating it every two years.  These staff include (but are not limited to):  lab staff who physically handle tissue samples whether or not they are 'relevant material' under the Human Tissue Act 2004, clinical staff who seek consent for collection of samples, and anyone who is involved in applying for ethical approval to collect or use material, along with the PIs/CIs who are responsible for groups working with human tissue. All are considered to be working with human tissue although not all will be working under an HTA Licence.  The Human Tissue Act 2004 is a law that applies to everyone, though the licensing requirements do not apply to everyone as the Act outlines many exemptions from licensing.

If you work with human tissue you need to know about the Human Tissue Act 2004 and complete training on the Act, updating it every two years.  At the University of Oxford only a subset of people working with human tissue work with collections registered under an HTA licence (the rest work with human tissue exempt from licensing, most commonly either on non-relevant material or under ethical approval from an NHS Research Ethics Committee).  If you think that a collection of samples has not been registered under an HTA Licence but is not exempt from licensing requirements, contact the Human Tissue Governance Team (HTGT) in the first instance.

Specific activities with human tissue are covered by different types of HTA licences. There are four HTA Research licences, one Anatomy licence and one Human Application licence at the University; all of which are represented on the Human Tissue Governance Committee, which reports to the Medical Sciences Division (MSD) Research Committee. 

 All six of these licences have their own Designated Individual or “DI”.  The table below outlines the different HTA licences at the University of Oxford along with associated contact details:

University Licensed premises HTA licence Designated Individual Licence Contact
Richard Doll Building (CTSU) Research 12168 Mike Hill Chloe Bird
Sherrington Building (DPAG) Anatomy 12178 Thomas Cosker Thomas Cosker

Churchill and

John Radcliffe Hospitals,

Nuffield Orthopaedic Centre and Botnar,

Old Road Campus, Pharmacology (Mansfield Rd), Peter Medawar Building

Research

12217

Brian Shine Human Tissue Governance Team for HTA Licence 12217
List of Persons Designated
OCDEM Research 12326 Fredrik Karpe Thomas Clague
WIMM Research 12433 Kathryn Robson Kathryn Robson
Oxford DRWF Human Islet Isolation Facility Human Application 22496

Paul Johnson

Paul Johnson

 

The University is the Corporate Licence Holder for all University HTA licences, and the Corporate Licence Holder contact is Carolyn McKee, who is the MSD’s Head of Commercial Strategy and Risk.

If you work anywhere else within the University or for the OUH NHS Foundation Trust and need help with matters of HTA compliance, contact the Human Tissue Governance Team for Licence 12217 in the first instance. 

If you are aware of human tissue being stored outside of licensed premises and without a licensing exemption, please contact the Human Tissue Governance Team.

Many labaratories label freezer doors or storage areas as one indicator of what samples are under a Licence or exempt from licensing. The most common exemptions from licensing are storage of non-relevant material (eg serum, cell-free plasma, DNA etc) or current and valid approval from an NHS REC (directory of all recognised RECs).  Please be aware that REC approvals expire and that only samples stored for the activities explicitly approved by the REC are exempt from licensing.  Many collections under an HTA licence will also have MS IDREC, OxTREC, or foreign REC approval for processing. These RECs do not provide an exemption from licensing. Ask how collections’ ethical approvals or licensing is documented within the group where you work if you are uncertain what is under a licence or exempt.

Licensing exemption carries on for 12 months after the end of study notification was submitted to the REC.  CTRG/the sponsor should be copied into this notification.

As early as possible after the end of study notification has been submitted to the REC, notify your HTA Licence contact and Human Tissue Governance Team to avoid a breach of the licensing requirements of the legislation. They will help you make an appropriate plan to continue storing samples in compliance with the law, if you require it.

If you are aware of samples of relevant material being stored past the end of the 12 months without them having been registered under an HTA licence then contact the relevant person in the contacts table above.

If you are aware of samples of relevant material being stored outside the governance of an HTA Licence under ethical approval which did not come from an NHS REC, follow incident reporting procedures.

Use the contacts table above as a guide to the best person to contact. Remember, you can always contact the Human Tissue Governance Team for HTA Licence 12217 (HTGT) or see the HTG website for online resources.  Although this team’s remit is one licence, they can also provide generic advice, support, and guidance to University staff.

If not, or if the inventory or tubes include personal identifiers, or does not have a unique identifier for every aliquot,  or if the inventory exists only in hard copy, ask your licence contact (above) for advice.

If there are not valid consent forms on-site or that can be recalled from archive by local staff, or a consent tracker spreadsheet/database, or a valid Research Agreement (eg a Material Transfer Agreement) signed by a University signatory (not a PI) which guarantees consent, ask your licence contact (above) for advice.

If there are any conditions on the consent (eg limited duration of consent or consent only for specific uses) which are not captured in the inventory or a consent tracker log, ask your licence contact (above) for advice.

If you cannot show that the tube labelling and the inventory both show the same information regarding sample ID and sample type, ask your licence contact (above) for advice.

If a donor withdrew consent and their name could not be linked to participant ID(s), sample IDs, and all samples and aliquots from the donor found, ask your licence contact (above) for advice.

Find out who can link donors’ names to participant IDs within your group.

If you have access to electronic and controlled hard copies of local documents, which do you choose?  If you prefer hard copies, how do you ensure that you are accessing the latest version of a document?  Do you keep any uncontrolled printouts or photocopies of documents or save them on a local computer?  If so, how do you ensure that you are aware of updates/new versions of documents and that you replace uncontrolled copies upon update?  It is best practice to always access controlled* electronic copies of documents (eg via iPassport, SharePoint, or a networked drive) to avoid using outdated versions accidentally. 

 

*Controlled copies, which can be printed or electronic, are tracked so that they can be located and replaced when superseded by a new version.

Consent training

As well as being an HTA requirement, training for staff seeking consent from donors (including healthy volunteers, staff and students) for research is required by law for Clinical Trials of an Investigational Medicinal Product (CTIMPs). The UK Policy Framework for Health & Social Care Research also requires documented training for consent seekers. Types of consent training available are:

  • CTRG provides training options for Good Clinical Practice
  • The MRC Regulatory Support Centre provides ad-hoc in-house consent training
  • NHS Consent training for clinicians
  • NIHR training on informed consent and Good Clinical Practice – check their ‘Learning and Support’ website for further information.

Chief Investigator/Principal Investigators are responsible for ensuring all applicable staff (including themselves if they seek consent from participants) have appropriate and up-to-date consent training in place and that proof of completion (eg a valid certificate) is available for auditing purposes.  The Human Tissue Governance Team does not track individual completion of this training but may audit training records for samples stored under a University HTA Licence. Consent training needs to be updated at a minimum every three years.

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