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.
Research Licensing Standards and Guidance
This guidance helps licensed establishments to meet the HTA’s research licensing standards.
Extending licences to cover the removal of tissue from the deceased for research
Guidance on removing tissue for research.
Information for research tissue banks
In-depth information on the regulation of research tissue banks.
Consent for post-mortem examination and tissue retention under the Human Tissue Act 2004
Guidance on retaining tissue for research from a post-mortem.
Further resources for the research sector
General Medical Council
The GMC provides guidance setting out good practice principles for doctors involved in research.
The Medical Research Council Regulatory Support Centre
The Medical Research Council Regulatory Support Centre produces an e-learning resource, in consultation with the HTA, which provides an overview of human tissue legislation in the UK as well as best practice guidance and practical tips for compliance. Their Data and Tissues tool kit provides practical guidance on the regulatory and governance requirements when using personal information and/or human tissue samples in research.