FAQs

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The Human Tissue Authority (HTA)’s website is an excellent resource for finding information relevant to the research sector. It includes a frequently asked questions section.

The designated individual (DI) is Dr Brian Shine. Please contact the Human Tissue Governance team in the first instance. Your query will be forwarded to the DI where appropriate.

The University of Oxford is licensed by the Human Tissue Authority (HTA) for the storage of relevant material which has come from a human body for scheduled purposes. HTA licence 12217 covers the following premises:

  • all buildings in the John Radcliffe Hospital including the Main JR, the West Wing and Children’s Hospital, the Eye Hospital, the Academic Centre, the Women’s Centre, the Weatherall Institute of Molecular Medicine (WIMM)
  • all buildings in the Churchill Hospital including the Main Churchill wards, the John Warin ward and Vaccine Centre, the Cancer and Haematology Centre
  • all buildings on the Old Road Campus including the Old Road Campus Research Building (‘green building‘), the Kennedy Institute, the NDM Research Building, the Henry Wellcome Building
  • the Nuffield Orthopaedic Centre including the Botnar Research Centre
  • the Pharmacology building on Mansfield Road

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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).

If steps have been taken to remove cells from human tissue samples (eg lysis buffer, centrifugation), the resulting samples may be considered acellular. There is no need to prove that no whole cell remains in the samples, for example by microscopy.

There are no agreed protocols to render samples acellular (eg removing platelets from plasma). If the researcher storing the samples reasonably believes them to be cell-free then they may be considered as such. If on the contrary, no steps are taken specifically to remove the cells from samples, or the researcher believes cells may remain (for example due to less stringent centrifugation), then the samples have to be considered relevant material.

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No, there are several exemptions to HTA licensing, which are detailed in the HTA’s Code of Practice E from paragraph 80. 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 the 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. To register samples under HTA licence 12217, please contact the Human Tissue Governance team to obtain a copy of the relevant documentation.

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.

The Health Research Authority (HRA) lists recognised RECs on their website.

Ethical approval from another country is not a valid exemption from the licensing requirements of the HT 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 HTA licence 12217, please contact the Human Tissue Governance team to obtain a copy of the relevant documentation.

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 an MTA from the RTB.

Once a project using material released from a research tissue bank 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 (ie whether they contain human cells which have not divided outside of the body); and
  2. whether the planned use for the sample(s) is a scheduled purpose as defined by the HTA.

Guidance issued by 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:

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 eg demonstration of a technique, 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 DI may allow the registration of the samples under licence 12217 if the collection complies with HTA standards and the conditions of the licence. Once registered under the 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.

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 (eg material transfer agreement, service level agreement, 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 appropriate CUREC sub-committee (eg MS IDREC).

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The Head of the Medical Science Division has decided to make training on the HT Act, the HTA and its codes of practice and standards (WebLearn training) mandatory for all staff involved in human tissue research, working under REC approval or otherwise.

However, unlike the WebLearn training which is required of all staff working with human material, the core standard operating procedures (SOP) for licence 12217 only apply to collections registered under the licence. Researchers working with samples under REC approval do not need to comply with these procedures.

For staff working under licence 12217, the core SOP on disposal 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 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 to CTRG.

The Human Tissue Governance Team for Licence 12217 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.

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