Human tissue governance FAQs & glossary

Relevant material is defined as material which is made of or contains cells from a human body. The HTA website gives information on relevant material.

The cells do not have to be viable to be considered relevant. Microscope slides with cellular tissue are considered relevant material as they are representative of whole cells.

Material which is not considered relevant material includes:

• acellular material (eg serum, platelet-free plasma)
• extracted nucleic acids (RNA, DNA), proteins, extracellular vesicles
• cell lines that have divided outside the human body
• xenografts
• samples containing cellular debris only (eg after lysis)

Note that primary cells removed from a human body are considered relevant material if stored before they are cultured or before they are transferred into an animal in the case of xenografts.

It is important to note that embryos and gametes are not considered relevant material under the Human Tissue Act, but are regulated under the Human Fertilisation and Embryology Authority (HFEA).

The HTA’s guidance on whether material is relevant or non-relevant is available on the HTA website.

The page includes the following clarification on rendering material acellular: 'Although cell damage can be minimised by controlling the rate of temperature change and/or by adding one or more ‘cryoprotective’ agents, freezing/thawing can cause cell damage such that no whole cells remain. Centrifugation can be used to remove residual platelets from plasma, rendering it acellular, but the effectiveness is dependent on the protocol used. In either case, sufficient validation data (either in-house or published research) should be provided if the techniques are to be relied on to render samples acellular.'

No, there are several exemptions to HTA licensing, which are detailed in the HTA’s Code of Practice E from paragraph 80 and on the HTA’s website. The most common exemption is if the samples are under a current and valid ethical approval from a recognised REC (including samples released under a research tissue bank’s ethical approval).

Unless a valid exemption is in place, the samples must be placed under the governance of the HTA licence. This means that they must be registered under an HTA licence and the collection must be audited against the HTA standards for research. This ensures that the designated individual for the licence has oversight of all the samples under the licence and can monitor compliance with the legislation.

If you have a query about HTA licensing requirements at the University, please contact the Research Governance, Ethics & Assurance Team.

Yes, because University ethics committees are not recognised by the HTA for the purpose of licensing exemption.

'Recognised RECs' are either RECs established under and operating to the standards set out in the governance arrangements issued by the UK health departments, or ethics committees recognised by the United Kingdom Ethics Committee Authority (UKECA) to review clinical trials of investigational medicinal products under the Medicines for Human Use (Clinical Trials) Regulations 2004. NHS RECs and NRES RECs also refer to recognised RECs.

A list of recognised RECs can be found on the Health Research Authority's website.

More information is available on the Research ethics (including CUREC) webpages. 

Ethical approval from another country is not a valid exemption from the licensing requirements of the Human Tissue Act. The samples must be registered under an HTA licence, or approval must be sought from a recognised REC to analyse the samples in the UK.

In any case, an appropriate research agreement (such as a material transfer agreement or tissue transfer agreement) must be put in place between the institution the samples are being sent from and the University of Oxford before the samples are transferred to Oxford.

For information on research agreements, please contact your research contracts specialist. To register samples under a University HTA licence, please contact hta_help@admin.ox.ac.uk.

More information is available on the Research ethics (including CUREC) webpages.

No. Samples released from an RTB in England, Wales and Northern Ireland under RTB ethical approval are exempt from HTA licensing requirements.

This is because such biobanks operate under ethical approval from a recognised REC, which they can confer to projects they release material for. Recipients of such tissue must hold evidence that the tissue has been obtained from the biobank under their REC. This may be in the form of a material transfer agreement (MTA) from the RTB.

Once a project using material released from a RTB finishes, the researcher storing the samples must refer to the MTA for instructions on what to do with any leftover material. Typically, leftover samples must be disposed of, returned to the biobank, or a new application submitted to the biobank for use of the samples in a new project.

The requirements differ depending on:

1. whether the tissue samples would be considered 'relevant material' by the HTA (whether they contain human cells which have not divided outside of the body)
2. whether the planned use for the samples is a scheduled purpose as defined by the HTA

Guidance from the Central University Research Ethics Committee (CUREC) is available to determine which type of ethical approval, if any, is required for work involving samples from healthy volunteers:

• BPG 15 Ethics review of research with human tissue

  BPG 15 Ethics review of research with human tissue

HTA licensing is required if the samples are relevant material, are stored for a scheduled purpose, and there is no ethical approval from a recognised REC (NHS/HRA). For tissue obtained from the living, scheduled purposes do not include:

1. performance assessment: use of material in the evaluation and assessment of in-vitro diagnostic kits, calibration of devices
2. education or training related to human health, for example demonstration of a technique or training to take blood
3. quality assurance: use of material as part of systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met

Therefore, samples used for performance assessment, education or quality do not need to be registered under an HTA licence.
The HTA’s Code of Practice E on Research details licensing requirements in paragraph 84.

Provided there is consent to store and use the samples for research beyond the original research project (generic and enduring consent), the designated individual may allow the registration of the samples under a University HTA research licence if the collection complies with HTA standards and the conditions of the applicable licence. Once registered under a licence, the samples may be stored for scheduled purposes including future research.

Note that ethical approval is still required for the use of the samples in research.

Samples without any evidence of generic and enduring consent beyond the original research project must not be held.

For any samples collected after 1 September 2006 registered under licence 12217, collection custodians must hold consent records or a suitable secondary evidence that consent was sought.

The Human Tissue Act considers imported samples exempt from the consent requirements that apply for samples collected in England, Wales or Northern Ireland, but it is licence 12217 policy that assurance is sought from sample providers abroad that informed consent was sought from participants.

If you do not hold a copy of the consent form, an appropriate agreement (for example a material transfer agreement, service level agreement or site agreement) signed by Research Services can be used to evidence that the provider site warrants that consent is in place for all samples transferred to Oxford.

Samples collected after 1 September 2006 and stored for a scheduled purpose without any evidence that consent was sought from donors must not be held.

For guidance on applying for ethical approval see the CUREC webpages.

If the samples are to be used for research and their use is not covered by ethical approval from a recognised REC (for example as part of an existing project using samples from NHS patients), they should be registered under an HTA licence and ethical approval sought from the Medical Sciences Interdivisional Research Ethics Committee (MS IDREC), unless the study is funded by a US Federal Funding Agency, in which case approval should be sought from OxTREC.

For staff working under licence 12217, the core SOP on disposal (HTA005) details procedures to follow for the disposal of human tissue samples.

Local procedures may also apply: please consult your local laboratory manager.

For disposal of hazardous samples (eg chemical storage buffers, infectious material), please contact your local safety officer or the University Safety Office for advice.

The GDPR is a legal framework that outlines requirements for the collection and processing of personal information of individuals within the European Union (EU) and replaces the Data Protection Act (DPA).

The GDPR applies to the processing (collection, storage, analysis etc) of personal data. Personal data is information that relates to a living individual who can be identified from that information, whether directly or indirectly, and in particular by reference to an identifier. It includes, for example, a name, an identification number (eg pseudonymised data), location data, audio/video recording or an online identifier, such as the IP address. It could also include information that identifies an individual’s characteristics, whether physical, physiological, genetic, cultural or social. Sensitive personal data (relating to race, ethnicity, sexual orientation, politics, religion, health, trade union membership, genetics, sexual life, biometrics (where used for ID purposes), or criminal activities) is referred to as special category data under the GDPR.

For more information, please refer to the University's guidance on data protection and research, the HRA’s website, the MRC’s website.

If researchers have any queries related to GDPR in the context of their particular research study or clinical trial, they should address these RGEA.

The University’s Human Tissue Group (part of Research Governance, Ethics & Assurance Team) has no legal basis to receive, process or store personal and sensitive data (in particular related to patients). Therefore, it is imperative that such information is not sent to us. Instead, please ensure you have anonymised the information appropriately before sending it to us.

Information on Human Tissue Act training at the University of Oxford can be found on our training page.

The Medical Sciences Division mandates that training on the Human Tissue Act and its related codes of practice and standards must be undertaken by anyone working with human tissue samples (relevant or non-relevant material) in research, whether under an HTA licence or a ‘recognised’ REC approval. However, unlike the HTA training which is required of all staff working with human material, the core Standard Operating Procedures (SOP) for any University HTA licence only apply to collections registered under that licence; researchers working with samples under REC approval do not need to comply with these procedures.

Information on Human Tissue Act training at the University of Oxford can be found on our training page.

This term is primarily used in relation to HTA Licence 12217. Collection responsible officers (CROs) assist principal investigators (PIs) in the day-to-day governance and curation of samples. They are named staff members who serve as liaison between the DI of HTA Licence 12217/Research Governance, Ethics & Assurance Team and the PIs and to whom responsibilities will be frequently delegated to perform actions related to HTA compliance and/or compliance with the terms of registration under the licence. PIs may act as CROs if necessary.

The person under whose supervision the licensed activity is authorised to be carried out. They have the primary (legal) responsibility under Section 18 of the Human Tissue Act to secure:

• that suitable practices are used in undertaking the licensed activity
• that other persons working under the licence are suitable; and
• that the conditions of the licence are complied with
  • The Designated Individual for Research Licence 12168 is Michael Hill
  • The Designated Individual for Anatomy Licence 12178 is Sally Vine
  • The Designated Individual for Research Licence 12217 is Brian Shine
  • The Designated Individual for Research Licence 12326 is Fredrik Karpe
  • The Designated Individual for Research Licence 12433 is hta@imm.ox.ac.uk 
  • The Designated Individual for Human Application Licence 22496 is Paul Johnson

An existing holding is defined as relevant material from a human body (whether living or dead) held before the day on which the Human Tissue Act commenced (1 September 2006) for use for a scheduled purpose. Such holdings are exempt from the consent requirements of the Human Tissue Act. However, researchers are still bound by the terms of any consent which was obtained from donors before this date, under common law. Existing holdings are subject to licensing requirements and HTA standards related to traceability, governance and quality and premises, facilities and equipment.

The largest HTA research licences held by the University of Oxford. This licence covers a wide range of premises primarily used by staff in the Medical Sciences Division. The premises covered by licence 12217 include all buildings at the John Radcliffe Hospital, all buildings at the Nuffield Orthopaedic Centre, all buildings at the Churchill Hospital, all buildings at the Old Road Campus (excluding the Oxford BioEscalator), the Pharmacology building on Mansfield Road, the Peter Medawar building on South Parks Road, and the new Biochemistry Building on South Parks Road.

Details of the scope, purpose and governance of the licence can be found in the licence constitution (HTA008).

The Human Tissue Act defines import/export as the movement of samples into or out of England, Northern Ireland and Wales. Movement of samples to or from Scotland is considered export/import.

Persons designated (PDs) assist the DI in carrying out the legal duty of complying with the conditions of the licence and the Human Tissue Act. Persons designated direct others in relation to the Human Tissue Act, assist in developing and implementing procedures to provide the DI with assurance of compliance. For example a person designated offers advice and guidance to those working in their department about how and why they need to follow procedures and systems agreed by the DI to comply with the Human Tissue Act.

For the purpose of the licence, a person is considered as working under licence 12217 if any aspect of their work comprises collecting, using or storing samples which are registered under the licence. This would include PIs, technicians, research nurses, project managers and administrative staff, those working with data and/or samples from collections registered under the licence. Persons working on licensed premises, but whose samples are used/stored under a licensing exemption are not considered as working under the licence, nor are persons working under another HTA licence. For further information see the HTA licence policy (HTA007).

Under the HTA standards ethical approval which qualifies for exemptions under the act can only be given by a recognised REC, which is either:

1. a REC recognised or established by, or on behalf of, the HRA under the Care Act 2014 or any other group of persons which assesses the ethics of research involving individuals and which is recognised for that purpose by, or on behalf of, the Welsh Ministers or the Department of Health in Northern Ireland; or
2. an ethics committee recognised by United Kingdom Ethics Committee Authority to review clinical trials or investigational medicinal products under the Medicines for Human Use (Clinical Trials) Regulations 2004.

University research ethics committees and overseas ethics committees are not considered as recognised RECs under the act.

Relevant material under the Human Tissue Act (2004) is defined as ‘material, other than gametes, which consists of or includes human cells’. Note that this does generally include cell deposits and tissue sections on slides, but not lysed cells, or samples which have been processed to remove cellular components. Cell cultures comprised of cells which have divided outside the human body are not considered relevant material. Please refer to the Human Tissue Authority (HTA) websitefor the full list of relevant material and exemptions.

The Human Tissue Act defines the purposes requiring consent as scheduled purposes. Research is a scheduled purpose under the Human Tissue Act. In addition, for samples collected from deceased donors, scheduled purposes include: clinical audit, education and training relating to human health, performance assessment and quality assurance. Samples stored for a scheduled purpose must be stored under the governance of an HTA licence unless an exemption applies, such as current and valid ethical approval from a research ethics committee recognised by the HTA.