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Health watchdogs and authorities

Human Tissue Authority (HTA)

The Human Tissue Authority (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 the HTA not only addressed this issue but also updated and brought together other laws that relate to human tissue and organs.

The HTA was created by parliament as an executive agency of the Department of Health and is overseen by an Authority of lay and professional members appointed by the government.

The HTA regulates more than 800 organisations that remove, store and use human tissue and organs for research, patient treatment/transplantation, post-mortem examination, education and training, and display in public. It also gives approval for organ donation and bone marrow donation from living people.

Building on the confidence people have in regulation, the HTA ensures that human tissue and organs are used safely and ethically, and with proper consent. Consent underpins the HTA’s role under the Human Tissue Act 2004. The EU Tissue and Cells Directive and the new EU Organ Donation Directive govern quality and safety for patient treatment. These laws ensure human tissue and organs are used safely and ethically, with proper consent and we provide advice and guidance about all of this legislation.

Members of the public are more confident to donate if they know there is a regulator of human tissue and organs. Patients and families also have more confidence that their wishes will be respected, that organs and tissue used in treatment will be safe and of high quality, and that tissue used for research or other purposes will be put to the best possible use, if they know regulation exists.

By fostering an environment of trust, HTA hopes 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.

Consent and when it is required

Giving consent means giving permission for human tissue to be used for purposes set out in law. Anyone removing, storing or using material for purposes set out in the Human Tissue Act must be satisfied that consent is in place. In broad terms, consent is required to:

  • store and use bodies of the deceased
  • remove, store and use tissue or cells from bodies of the deceased
  • store and use relevant material from the living

The term "appropriate consent" means consent given by the right person. This could be a living person from whom tissue is being taken or, if that person has died, consent may be sought in some circumstances from someone who was close to them.

The giving of consent is a positive act. To be valid it must be given voluntarily and by a person with the ability to make an informed decision. When seeking consent, healthcare professionals or other suitably experienced people should ensure that it is appropriate for the intended purpose. The HTA does not regulate consent for diagnosis or treatment. 

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Page last reviewed: 20/11/2013

Next review due: 20/11/2015

What can bodies, organs, tissue and cells be used for?

  • to treat patients with particular medical conditions
  • for organ transplants
  • to treat blood disorders like leukaemia with stem cells
  • to research causes and treatments for illnesses, such as cancer or diseases of the brain and nervous system
  • to teach about the human body
  • to train medical students neccessary skills of surgeons
  • in public displays (exhibitions and museums)
  • in post-mortem examinations by examining organs and tissue samples to find the cause of death

 

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