The purpose of this policy is to set out the HTA's policy on human tissue xenografts, whether they are relevant material that fall under the licensing framework of the HT Act 2004 and the consent implications.
Xenografts are cells, tissue or organs that are transplanted from one species to another. Human tissue xenografts being the transplantation of human tissue into another species. Human tissue xenografts are widely used in research in connection with disorders, or the functioning, of the human body. The HTA has received enquiries regarding their use and the requirements of the HT Act 2004.
Human tissue xenografts are classed as ‘relevant material’ as they will contain cells that have come from human bodies.
Licensing requirements under the HT Act 2004
The application of human tissue xenografts is not considered a method of storing human tissue or cells and therefore does not require a storage licence. The human tissue will be integrated and become a part of the recipient species. However, where human tissues and cells are being stored for a scheduled purpose, such as ‘research in connection with disorders, or the functioning, of the human body’ before they are transplanted into a recipient species, a storage licence may be required.
When Consent is obtained for tissue and/or cells to be used in research and it is known at the time of obtaining consent that this would involve the transfer of the material to animal models, this should be explained to the individual and consent should be obtained for this. This is based on the requirement that for consent to be valid the individual should understand the nature and purpose of what is proposed and they should be told how the tissue will be used. The transfer of tissue and/or cells to an animal model is a significant step that the individual should be informed of and consent to.
Issued 28 July 2009, reviewed December 2013