The HTA licenses and inspects organisations across the six different sectors. We also assess living organ donation and bone marrow or peripheral blood stem cells donation from adults who lack capacity to consent and children who lack competence to consent.
The menu above and links below provide essential information for all those working in a HTA-licensed sector or HTA-regulated activity.
We do this to provide assurance to the public that bodies or tissue from the deceased are given with proper consent, and are used appropriately. As the regulator, the HTA cannot promote body donation but we do provide the public with support and information about body donation. People must decide, and provide written and witnessed consent before they die, if they would like to donate their bodies to medical science. Information about regulation in Scotland is provided by Health Scotland.
Under the Human Tissue Act 2004, any potential donation of bone marrow or peripheral blood stem cells (PBSC) from adults who lack capacity to consent and children who lack competence to consent, must be assessed by an Accredited Assessor and a report submitted to the HTA for decision.
The HTA trains Accredited Assessors (AAs) to assess potential bone marrow and PBSC donations from adults who lack capacity and children who lack competence to consent.
Once accredited by the HTA, AAs act as a representative for the donor and the HTA.
Following an assessment, AAs submit a report of their assessment to the HTA. The HTA makes the decision whether or not to approve the proposed donation.
Under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) (Q&S Regulations), the HTA licenses and inspects establishments that undertake the procurement, testing, processing, storage, distribution, import and export of tissues and cells for human application.
Licensed establishments include a wide range of organisations such as hospitals, stem cell laboratories and tissue banks, as well as private companies such as cord blood banks, suppliers of acellular material and establishments that procure the starting material for Advanced Therapy Medicinal Products (ATMPs). Establishments licensed under the Q&S Regulations work with a wide variety of tissue/cell types, including bone, skin, heart valves, bone marrow, stem cells, chondrocytes, and pancreatic islets.
Licensed establishments are required to meet the standards which are detailed in the HTA’s ‘Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment’ as implemented by Directions 001/2021. These Directions consolidate and clarify the standards required under the Q&S Regulations.
Under the Human Tissue Act 2004, any potential donation of a solid organ or part organ for transplantation must be assessed by an Independent Assessor and a report submitted to the HTA for consideration. The HTA trains and accredits Independent Assessors (IAs) to assess certain types of living organ transplantation in the UK.
Once accredited by the HTA, IAs act as a representative of both the donor and the HTA in order to help the HTA ensure the requirements of the Human Tissue Act 2004 have been met. IAs submit a report of their assessment to the HTA. The HTA makes the decision whether or not to approve the proposed donation.
In England, Wales and Northern Ireland, mortuaries where post-mortem examinations take place are licensed and inspected by the HTA. We help mortuaries improve the standard of care they provide, so the public can have confidence that deceased people are treated with dignity and respect. Please note that the HTA does not license post mortem establishments in Scotland. Information about regulation in Scotland is provided by Health Scotland.
We also provide publicly-available advice and information so that bereaved families can make decisions about what should happen to organs and tissue samples removed during a post mortem examination for further examination, after the cause of death has been ascertained. In regulating post mortem examination, we work closely with pathologists. However, we do not regulate their professional practice. We also maintain close links with coroners, who fall outside the scope of our regulatory activity.
Human bodies, body parts and specimens may be put on public display, for example as part of an exhibition in a gallery or museum. If they are from the body of a deceased person who died less than 100 years ago, the premises must be licensed by the HTA for public display. In England, Wales and Northern Ireland, consent must be given by the person themselves for any part of their body to be displayed in public. If the person wants to give consent for their body, or any part of it, to be displayed after their death, their consent must be written and witnessed. HTA regulation of the activity of public display provides assurance to the public that bodies or tissue from the deceased that are displayed to the public are handled with care and treated with respect.
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.
Organ transplantation is the only treatment for end stage organ failure and the most cost effective treatment for renal failure. The use of organs requires that their quality and safety should minimise any risks with transmission of disease. Additionally, mechanisms to facilitate the exchange of available organs to ensure that these reach a suitable recipient should be in place.
Our standards are based on the Framework document produced following consultation with professionals already working in the field of organ donation and transplantation and cover both procurement (characterisation of donor, characterisation, retrieval, preservation and transport of an organ) and transplantation (organ characterisation, preservation, transport and implantation).