Human Tissue Authority

The regulator for human tissue and organs

Research

The term ‘research’ is often used to mean a wide range of activities which might be laboratory - or treatment-based. The type of research regulated by the HTA is perhaps best thought of as ‘laboratory bench’ research. We ensure that this tissue is removed and stored in an appropriate and well managed way.

We license organisations for removal and storage for research in England, Wales and Northern Ireland. Our licensing role in research is limited to licensing premises - such as tissue and brain banks - storing tissue from the living and deceased. We also license establishments - including post mortem establishments - where tissue is removed from the deceased for research.

We do not license the ‘use’ of tissue for research or approve individual research projects or clinical trials. Neither do we have a role in the ethical approval of research. We do, however, work in partnership with other organisations to ensure that the regulatory environment is easy for researchers to navigate and understand.

Although the Act requires that removal of tissue from the deceased for research is licensed, its storage can be exempt from licensing. A lot of tissue stored for research is automatically exempted from licensing and consent requirements, because it comes from living people and there is project-specific approval from a recognised Research Ethics Committee. Information about regulation in Scotland is provided by Health Scotland.

For the anatomy, organ donation and transplantation, public display, research and post mortem sectors
Guidance for hospital and mortuary staff on brain and spinal cord donation
Policy on the sale of bodies, body parts and tissue
HTA policy on human tissue xenografts as relevant material, the consent implications and the licensing requirements under the HT Act 2004.
This section explains the consent exemptions from the Human Tissue Act (2004)
Position statement on extending existing licences to cover the removal of tissue from the deceased for research
Position statement jointly produced and issued by the Human Tissue Authority (HTA) and the Health Research Authority (HRA).
Further resources for those working in the research sector
Position statement on consent for post-mortem examination and tissue retention under the Human Tissue Act 2004
Which research activities the HTA requlates and how consent should be obtained to use human tissue for research

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