Seeking Approvals: HTA licence

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Introduction

The Human Tissue Authority licenses a number of activities relating to human tissue, e.g. the storage of relevant material for a scheduled purpose such as research (England, Wales and Northern Ireland), post mortem (England, Wales and Northern Ireland) or human application (all of UK). Licences are issued per premises (by postcode area) and not on a per project basis.

This station provides information on the HTA licence for storage of relevant material for research. The Licensing section of the HTA website (1st resource) has detailed information on the licensing requirements for other sectors.

The MRC Regulatory Support Centre e-learning module Research and human tissue legislation (2nd resource below) provides an overview of UK human tissue legislation and includes information on when a licence is required for the purposes of research and the standards expected, focusing on quality and the need for consent.

The MRC Regulatory Support Centre Licensing summary (3rd resource below) outlines when a licence is required for research, including the licensing exemptions and the standards expected. In general, a licence is required to store human tissue for research unless it is being stored for an NHS REC approved project.

A licence for storage for research is not required where:

  • The material being stored is not relevant material, i.e. does not contain or consist of whole cells (more information on relevant material is in the 4th resource below); or
  • The relevant material will be transported to licensed premises or rendered acellular within hours, days and certainly no more than one week; or
  • The relevant material is being stored for use in project(s) that have/are pending NHS REC approval. In these circumstances the organisation should consider what will happen to the relevant material at the end of these ethically approved projects(s). i.e. The licensing requirements will then need to be met and so the tissues may be transferred to a licensed establishment or further NHS REC approval sought; or
  • The samples are being stored in Scotland (there is no licensing requirement in Scotland apart from when storing for human application e.g. for transplantation).

All Research Tissue Banks in England, Wales or Northern Ireland that distribute human tissue to third parties for use in their research projects require a licence, even though the bank itself may have Research Tissue Bank approval from an NHS REC.

PLEASE NOTE: If the Research Tissue Bank is based in Scotland then the tissue will not be stored on HTA-licensed premises and therefore third parties receiving tissue in England, Wales and Northern Ireland will need to store on HTA-licensed premises or the bank needs to have generic ethics approval for all projects (see below). Alternatively, third parties may have their own project specific NHS REC approval.

If a licence is required, applicants should apply to HTA online on the HTA website. Details on the application process, including guidance and fees, are available on the licensing section of the HTA website (1st resource).

Projects using tissue from an ethically approved bank
An NHS REC may give generic ethics approval for Research Tissue Banks. This approval can extend to specific projects receiving non-identifiable tissue from the bank. The tissue does not then need to be stored by third parties on HTA-licensed premises as it is deemed to have project specific ethical approval and the licensing exemption applies.

HTA Licensing requirements for diagnostic archives used as Research Tissue Banks
While purely diagnostic archives do not need to be stored on HTA licensed premises, if a diagnostic archive releases samples for research these samples will fall within the HTA licensing framework. Please see the HTA and the HRA's Research Ethics Service joint position statement on diagnostic archives for more information (5th resource below).

Associated Post Mortem licences can include storage for a scheduled purpose (i.e. research) so a separate research licence may not be needed. For more information please visit the Post Mortem section of the HTA website (6th resource below) and the HTA list of Post Mortem licences (7th resource below).

For information on the licensing requirements of the Human Tissue Act 2004, please see the HTA's Code of Practice on Research and their Research Standards and guidance, in the 8th resource below.

It is important to honestly assess current standards within your organisation and outline plans for achieving the HTA standards. If the HTA choose to inspect your institution, they will inspect performance against the HTA standards as well as to any conditions which may be applied to your licence. More information on HTA inspection is available in Audit and inspection.

The 9th resource below provides information on HTA Licence fees.

Resources