A uk parliamentary act which repealed, replaced and streamlined several acts. In november 2004 royal assent was finally given to the human tissue act which was passed in response to the organ retention scandals at alder hey hospital and other hospitals around the uk. The source of power to retain, use and hold human tissue and organs. The human tissue act 2008 was passed in april 2008 and came into force on 1 november 2008. N2 the human tissue act 2004 is designed to regulate the storage and use of organs and tissues from the living, and the removal, storage and use of the same material from the deceased. It also repealed and replaced the northern ireland ni human tissue act 1962, human organ transplants order 1989 and anatomy. The human tissue act 2004 new legislation on human organs and tissue what is the human tissue act 2004. Human tissue act 2004 and the role of research ethics committees recs the human tissue act 2004 hta sets up two requirements for the conduct of research on relevant material.
It consolidates previous legislation and created the human tissue authority to regulate the removal, storage, use and disposal of human bodies, organs and tissue. The human tissue act 2004 ht act is the legislative framework which governs the storage and use of relevant material from the living and the removal, storage and use of relevant material from the deceased, for a scheduled purpose. It will be overseen by the human tissue authority hta, which will regulate the removal, storage, use and disposal of human. For example, a spouse or partner is ranked higher than a parent or child, who in turn is ranked higher than a brother or sister. The regulations that govern this area differ from one country to another, but in the uk, the human tissue authority hta oversees the process, which may be regulated by the human tissue act 2004. The uk human tissue act 2004, 1 designed to regulate all activity involving human tissue, organs, or bodies, was introduced in the house of commons in december 2003, received royal assent on 15 november 2004, 2 and has been partially implemented by commencement orders from april 2005. It established the hta to regulate activities concerning the removal, storage, use and disposal of human tissue. Consent is the fundamental principle of the legislation. Revised legislation carried on this site may not be fully up to date. Human tissue is referred to in the act as relevant material see definition below. But on closer inspection a more complex position emerges. There are changes that may be brought into force at a future date.
The human tissue act came into force on 1st september 2006, having been passed as law in 2004. Tissue which is taken from live individuals for diagnosis or treatment requires consent which is generally taken when the person consents to their. Implementation of this act may be staggered, but it will be fully operational in may 2006. A guide to the human tissue act and the use of the tissue bank. It repeals much criticized legislation, including the human tissue act 1961, and establishes a human tissue authority to ensure compliance with the act via a. It replaces a variety of existing laws and establishes an updated legislative framework for regulating body donation and the removal, storage, and use of human organs and tissues. At first glance it may appear to set many of the concerns raised in the bristol interim inquiry and alder hey inquiry to rest. Different consent requirements apply when dealing with tissue from the deceased and the living.
The human tissue act 2004 david price introduction the human tissue bill, described in parliament as alandmark bill, was introduced into the house of commons on 3 december 2003 by secretary of state john reid, was brought to the house of lords on 29 june 2004, completed its. We were created by parliament as a nondepartmental. The human tissue act 2004 covers the storage, use and removal of human tissue. A brief guide to the human tissue act 2004, 2006 sage journals.
Human tissue act 2004 is up to date with all changes known to be in force on or before 20 february 2020. Whilst its main focus is to redress the inadequacy on the law on tissue retention the inclusion of the dna theft clause in the act section 45 has implications for good practice in relation to paternity testing. Despite its focus on consent the new human tissue act 2004 allows for testing without consent where a relative could benefit in recognition of the fact that genetic test results in people can have implications for close relatives, the new human tissue act 2004 allows for a direction to access a persons tissue so that testing can be carried out for the benefit of a relative, without the. The human tissue act 2004 will have an impact on two categories of licensable activities termed sectors that occur at the college. Organ transplantation and the human tissue act postgraduate. The human tissue act 2004 hta 2004 was introduced to address serious concerns raised in the course of the 1998 kennedy inquiry. The organ collection scandals of alder hey and bristol royal infirmary in the uk were the driving force for a comprehensive overhaul of the legislation and regulation of the handling and use of human tissues in the uk.
The new act, which repeals and replaces the human tissue act 1961, the anatomy act 1984, and the human organ. Aug 30, 2006 the human tissue act replaces the human tissue act 1961, the anatomy act 1984 and the human organ transplants act 1989. The human tissue act 2004 and the human tissue scotland act 2006 established the human tissue authority hta and has altered the way every potential donor is managed, be they deceased or living. The human tissue act 2004 has been formulated to improve regulation of how tissue and organs from the living and deceased are. Research in connection with disorders, or the functioning of the human body please tick option 1, 2, 2a as appropriate. This is defined as material that has come from a human body and consists of, or includes, human cells. It established the hta to regulate activities concerning the removal. The 1992 order required written donor and witness signatures for both donation and wishes. Human tissue act 2004 definition of human tissue act. A guide for the public to the human tissue act 2004 this guide is intended to be read alongside the human tissue act 2004. It aims to make consent a fundamental principle underpinning the use and storage of human tissue. Changes in the law may have a positive impact on organ donation on 1 september 2006, the legislation relating to organ donation within the uk changed. To be completed by the person making the donation please complete in block capitals. This represents the conclusion of the uk governments response to concerns about inappropriate retention of organs after postmortem examination, especially paediatric specimens.
It is a framework for regulating the storage and use of human organs and tissue from the living, and the removal, storage and use of tissue and organs from the deceased, for. Consent is the fundamental principle of the legislation and underpins the lawful removal, storage and use of body parts, organs and tissue. The human tissue act 2004 also created an offence of dna theft. Human tissue act 2004 definition of human tissue act 2004. The human tissue act 2004, anatomical examination and the. The human tissue act 2004 c 30 is an act of the uk parliament applying to england, northern ireland and wales. Implications of the human tissue act 2004 on tissue storage for. The human tissue act received royal assent on 15 november 2004. These late 1980s and early 1990s events had occurred. Human tissue act 1961, anatomy act 1984 and human organ transplants act 1989 as they relate to england and wales.
In england, wales and northern ireland, law reform came in the shape of the human tissue act 2004, although many of the finer details of the final shape of regulation have been left to the newly appointed human tissue authority. The act was brought about as a consequence of, among things, the alder hey organs scandal, in which organs of. The human tissue act 2004 david price introduction the human tissue bill, described in parliament as alandmark bill, was introduced into the house of commons on 3 december 2003 by secretary of state john reid, was brought to the house of lords on 29 june 2004, completed its progress through the upper house on 10 november 2004, and received the royal assent on 15 november 2004. It repealed and replaced the human tissue act 1964. In the human tissue act 2004 there is a hierarchy of qualifying relationships ranked with regard to provision of consent, so that the primacy of wishes can be determined. Reassurance for relatives, at a price o n 1 september 2006 the full provisions of the human tissue act 2004 came into force. Part 1 removal, storage and use of human organs and other tissue for scheduled purposes. Reviewed 062014 v4 a human tissue act 2004 consent form part a. The hta was established under the human tissue act 2004 with the aim of maintaining public and professional confidence by ensuring that human tissue and organs are used safely and ethically and with proper consent. The human tissue act 2004, anatomical examination and.
The human tissue act 2004 is designed to regulate the storage and use of organs and tissues from the living, and the removal, storage and use of the same material from the deceased. Nine national museums now have the power to deaccession human remains held in their collections under section 47 of the human tissue act 2004. The role of the 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 human tissue act 2004 is due to come into force in april 2006 and will resolve a number of uncertainties for researchers. Subscribe to this free journal for more curated articles on this topic. It is unlawful to have human tissue with the intention of its dna being analysed, without the consent of the person from whom the tissue came. This represents the conclusion of the uk governments response to. The human tissue act 2004 covers england, wales and northern ireland. The human tissue act 2004 is an act of parliament which created the human tissue authority hta to regulate the. The human tissue act 2004 repeals and replaces the human tissue act 1961, the anatomy act 1984 and the human organ transplants act 1989 as they relate to england and wales, and the corresponding orders in northern ireland. Tissue scandals prompted increased governmental oversight 1 and in 2004 the usa food and drug administration issued rules for human cells and tissue products with a simple and clear objective. On 1 september 2006 the full provisions of the human tissue act 2004 came into force. The adopted regulatory approach is not dissimilar to that adopted for. It is a framework for regulating the storage and use of human organs and tissue from the living, and the removal, storage and use of tissue and organs from the deceased, for specified healthrelated purposes and public display.
The ultra uk agency and the post of hm inspector of anatomy were abolished and their functions transferred to the authority. The ht act makes consent the fundamental principle underpinning the lawful storage and use of body parts, organs and tissue from the living or the deceased for specified healthrelated purposes and public display. Changes and effects are recorded by our editorial team in lists which can be. The human tissue act 2004 regulates the removal, storage and use of human tissue. The human tissue act received royal assent in november 2004, and was fully enacted on september 1st 2006. There had also been some strong arguments in favour of retaining human remains. Free of any items likely to cause a puncture of the bag. The regulation of the market for the prevention of tissue.
1606 258 1523 1106 168 456 1017 1398 93 857 1070 609 314 947 1646 668 132 625 804 116 156 456 735 765 642 1498 747 440 439 1033