Policy on human tissue xenografts

HTA policy on human tissue xenografts as relevant material, the consent implications and the licensing requirements under the HT Act 2004.

Issued 28 July 2009 

Purpose

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.

Background

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.

Relevant material

Human tissue xenografts are classed as relevant material as the sample will contain cells that have come from a human body. If a sample is known to contain even a single cell that has come from a human body, the sample should be classified as relevant material.

Licensing requirements under the HT Act 2004

Human tissue xenografts are not considered a method of storing human cells and therefore do not require a licence for their storage. The human tissue will be integrated and become a part of the recipient species, the material will have been used and it will not be possible to retrieve the sample from the recipient.

Consent requirements

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.