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Compliance with the Human Tissue Act

For information regarding the Human Tissue Act and storage of human tissue please go to the relevant sections. 

 

The Human Tissue Act 2004

The Human Tissue Act (2004) (HT Act) is the legislative framework which governs the storage and use of relevant material from the living and the removal, storage and use of relevant material from the deceased, for a scheduled purpose.

The Act focuses on both consent and licensing making consent fundamental to the removal, storage and use of human tissue for certain scheduled purposes.

Relevant material, as defined by the HT Act, is material derived from a human body (other than gametes*) which consists of or includes cells (including bodily waste products).

The following are excluded from the Act:

  • Hair and nail from the body of a living person
  • Embryos outside the human body * 
  • Cell lines and other material created outside the human body 
  • Any sample that has been rendered acellular within 7 days of initial sample receipt

*Regulated by Human Fertilisation and Embryology Act 1990

A supplementary list of relevant material is available from the Human Tissue Authority.  This list is neither exhaustive nor exclusive.   Potential users of human tissue are asked to seek guidance from Human Tissue Authority website where classification of human tissue is unclear. If at that point queries remain, please contact the Research Governance, Ethics and Integrity Team for additional guidance and support.

The Human Tissue Authority (HTA)

The Human Tissue Authority regulates activities related to the HT Act and issues codes of practice and practical guidance for the storage and use of human tissue.  It acts as the licensing authority and carries out inspections to ensure that licence conditions are met.

The following licences are held by the University:

HTA Research Licence - Designated Individual: Dr Paul Kingston

HTA Anatomy Licence - Designated Individual: Professor Ingrid Gouldsborough

HTA Human Application License- Designated Individual: Professor Sue Kimber

Licensing of human tissue for research

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

  • For the storage of human tissue samples which consist of or contain whole cells (some exemptions apply) for research where such research is not covered by current project specific NHS research ethics approval. 

Existing collections, imported material and tissue held for a project approved by a committee that is not an NHS Research Ethics Committee (e.g. a university ethics committee) must be stored under a licence from the HTA.

  • A licence is required by tissue banks that distribute tissue to researchers, even though the bank itself may have NHS REC approval.

All staff storing human tissue for research under the above conditions must register their activity with the Research Governance, Ethics and Integrity Team to ensure coverage under the University's HTA Licence for Research.