HTA licensing at the University of Oxford

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 the collection is licensed. If you are really unsure whether you work under an HTA licence, please contact us.

More than 2,000 staff in the Medical Sciences Division work with human tissue. They must all be aware of regulations in this field and complete training on the Human Tissue Act 2004, updating it every two years. 

They include (but are not limited to): 

• lab staff who physically handle tissue samples
• clinical staff who seek consent for collection of samples
• anyone who is involved in applying for ethical approval to collect or use material
• the PIs/CIs responsible for groups working with human tissue

All are considered to be working with human tissue although they do not all work under an HTA licence. The Human Tissue Act 2004 applies to everyone, even though the licensing requirements do not.

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 us 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 six of these licences have their own designated individual or 'DI'. The table below outlines the different HTA licences with associated contact details.

Many laboratories 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 (for example serum, cell-free plasma, DNA) or current and valid approval from an NHS research ethics committee (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. RGEA or 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 the Research Governance, Ethics & Assurance Team to avoid a breach of the licensing requirements of the legislation. We 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 registration under an HTA licence then contact the relevant person in the contacts table below.

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.

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

There should be valid consent forms, either on site or that can be recalled from archive by local staff, or a consent tracker spreadsheet or database, or a valid research agreement (for example a material transfer agreement) signed by a University signatory (not a PI) that guarantees consent. If none of these is in place, ask your licence contact for advice.

If there are any conditions on the consent (for example 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 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 for advice.

If a donor withdrew consent and their name could not be linked to participant IDs, sample IDs, and all samples and aliquots from the donor found, ask your licence contact 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 and new versions of documents and that you replace uncontrolled copies upon update? 

It is best practice to always access controlled electronic copies of documents (for example in 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.