Handling of Human Material

The Human Tissue Act 2004

The Human Tissue Act 2004 (hereafter, "the Act") is the legislative framework in England, Wales and Northern Ireland which governs the removal, storage, use and disposal of 'relevant human material' from the living and the deceased for 'scheduled purposes'.

'Relevant human material', as defined by the Act, is material that has come from a human body (other than gametes) and consists of, or includes, human cells - including bodily waste products.

A full list of 'relevant material' is available from the Human Tissue Authority (HTA).

'Scheduled purposes' under the Act includes activities related to research, medicine, education and public display. A full list of the 'scheduled purposes' can be found in the glossary of the HTA Codes of Practice.

The Act focuses on both consent and licensing, making consent the fundamental principle underpinning the lawful removal, storage and use of human body parts, organs and tissue.

Consent

Under the Act, it is an offence to remove, store or use relevant human material for scheduled purposes without appropriate consent, subject to the exemptions laid out in the Codes of Practice. It is also an offence to have human material - including hair, nail, and gametes - with the intention of analysing the DNA without explicit consent.

Licensing

The Human Tissue Authority is the competent authority for implementing the Act and licenses establishments to store and use relevant material. A number of different licences are available, but it is of note that while the HTA research license allows for the storage of human tissue - it does not allow the use of tissue for research, or provide approval for individual research projects: this must be covered by ethical approval for the specific project. 

Responsibilities

If you plan to carry out any research with human material, you must have the appropriate approvals in place before you start your research. All researchers are responsible for:

  • obtaining appropriate ethical approval to use the human material
  • providing annual returns detailing the samples held on University premises to the Human Tissue Act Designated Individual upon request

Training material

Human Tissue Act An overview  

Human material video:

Contact

Please direct all queries on human material to humanmaterial@liverpool.ac.uk

Researchers working with human material are encouraged to visit the following resources: