The use of human tissue in research is highly regulated to protect tissue donors, their families and researchers.

Human Tissue Authority Research Licence

A HTA licence allows establishments to legally store human tissue for the scheduled purpose of research. This may be storage for current or future unspecified research. Scheduled purposes are defined as those which legally require consent under the HT Act.

HTA licences are overseen by a Designated Individual (DI) who has been approved by the HTA to act in this capacity. The DI has oversight of the storage of all Relevant Material held under the licence.

The HTA does not regulate or approve the use of the tissue for research; therefore any specific research studies involving human material stored under a licence must be subject to NHS Research Ethics Committee (REC) review. The HT Act legally requires consent be obtained for a number of ‘scheduled purposes’ of which one is the storage of relevant material for research.

A HTA research sector licence is required in the following circumstances:

  • To continue to store relevant material following the expiry of NHS REC approval
  • To store relevant material from healthy volunteers without NHS REC approval (studies must also be approved by University Ethics Committee)
  • To store imported or commercially sourced relevant material for use in a non-NHS REC approved research study
  • To store human tissue for bio-banking purposes, even where generic bio-bank REC approval has been granted to cover a programme of research

Notification of Intention to Store Relevant Material

The Designated Individual is required by the Human Tissue Authority to maintain an overview of all human tissue use within the institutions for which they are responsible, including tissue stored under NHS REC approval.

The HTA has declared an intention to note REC-approved studies during inspections to inform areas for future inspection to ensure that tissue is not stored outside REC approval unless under a licence.

A notification will be sent to the Human Tissue Governance Officer and DI of your intended research activities when you submit Ethics: Applicant, and Healthcare Sponsorship

However, SU internal ethical approval is not sufficient for projects involving the storage of tissue considered 'Relevant Material' for any period of time.

In addition, to SU ethical application the Human Tissue Governance Officer (HTGO) MUST be notified by email to in the following circumstances:

  • Where human tissue, considered 'Relevant Material', will be stored at Swansea University.
  • Where human tissue is being imported or exported outside of the UK for any research study.
    In this case, the Principal Investigators must complete and submit the HTA-FORM-Importation Justification and await authorisation.
    No human tissue may enter the university outside England, Wales or Northern Ireland before agreed by the HTGO and DI.
  • Where tissue is purchased from commercial sources; commercial tissue is subject to HTA licensing requirements and therefore may only be stored under an HTA licence or NHS REC approval.

Once you have notified the HTGO they will work with you to add your human tissue collection to the university's HTA licence.