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Health watchdogs and authorities

Human Tissue Authority (HTA)

The Human Tissue Authority (HTA) is a regulator, set up in 2005. The HTA was created by parliament through the Human Tissue Act 2004 (The Act). It is overseen by an authority of lay and professional members appointed by the government.

The HTA was established following events in the 1990s that revealed a culture in hospitals of removing and retaining human organs and tissue without consent. The Act addressed this issue as well as updating other laws relating to the use of human tissue and organs.

The HTA licenses and inspects more than 850 premises that remove, store and use human tissue and organs for:

It also gives approval for organ donation and bone marrow donation from living people.

The HTA ensures human tissue and organs are used safely and ethically, and with proper consent. The HTA's fundamental role, ensuring informed consent, is set out in the Act. The HTA is also the competent authority for EU Tissue and Cells Directive and the EU Organ Donation Directive. These govern the quality and safety of tissues, cells and organs for patient treatment.

The HTA aims to maintain public confidence in the use, safety and quality of tissues and organs. Public confidence in donation is higher when members of the public know there is a regulator of human tissue and organs. Patients and families have more confidence that:

  • their wishes will be respected
  • organs and tissue used in treatment will be safe and of high quality
  • tissue used for research or other purposes will be put to the best possible use

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 informed consent, given by the right person. This could be a living person from whom tissue is being taken. If that person has died, consent may be sought in some circumstances from someone who was close to them.

For consent to be valid, it must be given voluntarily and by a person with the ability to make an informed decision. The person seeking consent must make sure the patient or relative gives consent that is appropriate for the intended purpose.

The HTA does not regulate consent for diagnosis or treatment.


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

  • to treat patients with particular medical conditions
  • for organ transplants
  • to treat blood disorders such as 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 teach medical students necessary surgery skills
  • in public displays (exhibitions and museums)
  • in post-mortem examinations by examining organs and tissue samples to find the cause of death 


Page last reviewed: 29/12/2015

Next review due: 29/12/2017

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