The HTA is a regulator set up in 2005 following events in the 1990s that revealed a culture in hospitals of removing and retaining human organs and tissue without consent. The legislation that established us not only addressed this issue but also updated and brought together other laws that relate to human tissue and organs.
We were created by Parliament as a non-departmental public body (otherwise known as an "arms'-length body") of the Department of Health and Social Care, and are overseen by an Authority of lay and professional members appointed by the Government.
We regulate organisations that remove, store and use human tissue for research, medical treatment, post-mortem examination, education and training, and display in public. We also give approval for organ and bone marrow donations from living people.
The interests of the public and those we regulate are central to our work. We build on the confidence people have in our regulation by ensuring that human tissue and organs are used safely and ethically, and with proper consent. There are many different types of human cells and tissue, including skin, body parts, organs, and bone. Bodies, organs, tissue and cells can be used for many purposes including:
- Treating patients with particular medical conditions
- Transplanting into people whose organs have failed
- Treating patients who have blood disorders like leukaemia with stem cells
- Researching causes and treatments for illnesses, such as cancer or diseases of the brain and nervous system
- Teaching students about the human body and training to develop the skills of surgeons
- Display in public, such as exhibitions and museums
- Finding out through post-mortem examination why someone has died, including examining their organs and tissue samples to determine the cause of death
We believe that patients and families will have more confidence that their wishes will be respected, that organs and tissue used in treatment will be safe and high quality; and that tissue used for research or other purposes will be put to the best possible use, if they know there is regulation of human tissue and organs.
By fostering an environment of trust, we hope more people will be willing to donate their tissue for scientific and medical research, their organs for transplants, and their bodies for medical education and training. On that basis, we can help healthcare to flourish.
Human tissue can be studied to improve our understanding of health and disease. 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 as easy as possible 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.
Human bodies and body parts may be put on public display, in exhibitions and museums. In the UK, any person wanting to donate their body for display must give their consent when they are alive. We provide 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. Any organisation involved in public display must be licensed by the HTA, unless the remains come from people who died more than 100 years ago. The HTA does not license the display of photographic or electronic images.
Organs – including kidneys, liver, lung and pancreas - are transplanted into patients to save and improve the quality of life. Under EU law, the HTA licenses organisations across the UK to ensure the quality and safety of organs that are intended for transplantation. We have a similar role for tissue removed for patient treatment.
We do not promote organ donation. That is the role of NHS Blood and Transplant. We license establishments, and do not regulate individual clinicians or healthcare professionals.
Under the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended), the HTA licenses establishments in the UK that procure, process, store, distribute, import or export tissues or cells for human application. The HTA also licenses establishments which carry out serology testing in relation to the donation of tissues and cells for human application.
A post-mortem examination is a study of a body after death, usually carried out if the cause of death is unknown, sudden or unexpected. This is most often under the jurisdiction of the coroner. Sometimes it may be carried out at the request of the hospital to find out more about the patient’s illness or why they died.
In England, Wales and Northern Ireland, mortuaries where post-mortem examinations take place are licensed and inspected by the HTA. This is so the public can have confidence that deceased people are treated with dignity and respect.
We also provide advice and information to the public to help them make decisions about what should happen to organ and tissue samples that are removed for further examination, after the cause of death has been ascertained. In regulating post mortem examination, we work closely with coroners and pathologists. However, we do not regulate their professional practice.
We regulate, through an accredited assessment process, the donation of bone marrow and peripheral blood stem cells from children and adults who lack the capacity to consent. This process ensures consent is given by a person with parental responsibility, in the case of children that cannot make a decision for themselves. This ensures the person with parental responsibility understands the risks and that no reward is sought or offered.
Licensing - quality and safety of tissue and cells for patient treatment
The HTA licenses organisations across the UK to help ensure the quality and safety of tissue and cells used to treat patients, from donation through to use in treatment. We issue these licences to a wide variety of establishments, including eye banks (corneas), establishments storing umbilical cord blood, and organisations storing skin and bone to treat burns or bone injuries, and stem cells.
Stem cells have the potential to become medicines for wider use. We work closely with other regulators to help organisations to achieve this potential. We license establishments, but do not regulate individual clinicians or healthcare professionals.
Human bodies are used to teach students and to train surgeons and other healthcare professionals. We license organisations, such as medical schools, that carry out these activities in England, Wales and Northern Ireland. 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 information about body donation. Written and witnessed consent must be given in life if an individual would like to donate their body to medical science.
Living organ donation
We regulate, through an independent assessment process, the donation of organs from living people across the UK. We work to ensure that valid consent has been given by the donor which means they understand the risks, are donating of their own free will and that no reward is associated with the donation or transplantation.
Deceased organ donation
For organ donation from deceased people, we also oversee the legal consent requirements by providing advice and guidance to professionals via our Codes of Practice.
Licensing - quality and safety of organs intended for transplantation
Each hospital undertaking organ transplantation across the UK must be licenced by the HTA. This helps ensure the quality and safety of transplanted organs.