National health act, 2003 regulations relating to the import and export of human tissue, blood, blood products, cultured cells, stem cells, embryos, foetal tissue, zvgotes and gametes the minister of health has, in terms of section 68 of the national health act, 2003 act no. It aims to make consent a fundamental principle underpinning the use and storage of human 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 the act focuses on both consent and licensing, making consent fundamental to the removal, storage and use of human tissue for certain scheduled purposes. The human tissue act 2008 was passed in april 2008 and came into force on 1 november 2008. Directions given under the human tissue act 2004 implementing. Human tissue act ucl school of pharmacy ucl university. It established the hta to regulate activities concerning the removal, storage, use and disposal of human tissue. Giving consideration to the format of the display to ensure that it is. 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. 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. Human bodies, tissue, blood, blood products or gametes may be donated to prescribed institution or person purposes of donation of body, tissue, blood or blood products of deceased. The hta was established under the human tissue act 2004 with the aim of maintaining public.
This includes residual tissue following clinical and diagnostic procedures. The uk human tissue act 2004, designed to regulate all activity involving. Informed consent is now the fundamental principle underpinning the lawful removal, storage and use of human tissue and organs. Human tissue authority north devon district hospital. The human tissue act 2004 odt clinical nhs blood and. 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. 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 human tissue act comes into force on 1 september, but what is it and how will it work. The new act, which repeals and replaces the human tissue act 1961, the anatomy act 1984, and the human organ. Human tissue act 2004 definition of human tissue act 2004. Information about the act, including the consent framework, organ and tissue donor register, nontherapeutic use standard, and offences and penalties. Person justified in deciding not to collect or use tissue. 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 received royal assent on 15 november 2004.
The human tissue act 2004 covers england, wales and northern ireland. The human tissue act 2004 hta 2004 was introduced to address serious concerns raised in the course of the 1998 kennedy inquiry. These late 1980s and early 1990s events had occurred. At first glance it may appear to set many of the concerns raised in the bristol interim inquiry and alder hey inquiry to rest. 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. Reviewed 062014 v4 human tissue act 2004 consent form part a.
Research and the human tissue act 2004 dna analysis medical. Tissue act 2004 for the removal, storage and use of organs from deceased donors for the treatment of others. 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 human tissue act 2004, anatomical examination and. Human tissue act 2004 is up to date with all changes known to be in force on or before 25 august 2019. The human tissue quality and safety for human application regulations 2007 3. The human tissue act 2004 is due to come into force in april 2006 and will resolve a number of uncertainties for researchers. 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. There are changes that may be brought into force at a future date. Different consent requirements apply when dealing with.
Human tissue act 2004 2004 chapter 30 an act to make provision with respect to activities involving human tissue. 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. The human tissue working group htwg was established to consider all aspects of the hta licensing requirements. The hta also gives approval for organ and bone marrow donations from living people. In september 2006, the uk human tissue act,1 which gained royal assent in. The human tissue act came into force on 1st september 2006, having been passed as law in 2004. This is defined as material that has come from a human body and consists of, or includes, human cells. Return one copy to the bequest office, centre for comparative and clinical anatomy, university of bristol. Human tissue authority definition of human tissue authority. The human tissue act received royal assent in november 2004, and was fully enacted on september 1st 2006. A uk parliamentary act which repealed, replaced and streamlined several acts. 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.
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. The human tissue authority hta is an executive nondepartmental public body of the department of health and social care in the united kingdom. 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. 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 replaced the human tissue act 1961, the anatomy. The human tissue act replaces the human tissue act 1961, the anatomy act 1984 and the human organ transplants act 1989. To provide for the donation or the making available of human bodes and tissue for the purpose of medical or dental training, research, or therapy or the advancement of medicine or dentistyr in general, for the postmortem examination of certain human keywords. The hta was established by the human tissue act 2004 the act. The human tissue act 2004, anatomical examination and the importance of body donation in northern ireland samantha j taylor and david j wilson division of basic medical sciencesanatomy, school of medicine and dentistry, the queens university of belfast, whitla medical building, 97 lisburn road, belfast bt9 7bl. Separate legislation in scotland the human tissue scotland act 2006. 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. The quality and safety of organs intended for transplantation regulations 2012 4. Tissue from the living means tissue taken while the person was alive, and this definition persists after their death.
Under the terms of the human tissue act, waht and the university of bristol are corporate licence holders. Tissue that was taken from the living for diagnosis and subsequently stored in a diagnostic archive can be valuable for use in research in connection with the disorders, or the functioning of, the human body. Human tissue act 2004, section 5 is up to date with all changes known to be in force on or before 07 may 2020. The human tissue act 20041 ht act sets out a legal framework for regulating the storage and use of human.
If your work involves storing human tissue in cellular form i. It consolidates previous legislation and created the human tissue authority to regulate the removal, storage, use and disposal of human bodies, organs and tissue. Research and the human tissue act 2004 consent medical. The part of the act dealing with the activities associated with the traditional dissecting room, socalled anatomical examination, dates back over 170 years when it was argued that a knowledge of the causes and nature of sundry diseases which affect the body and of the best methods of treating and curing such diseases and the healing and. Human tissue act 2004 regulates removal, storage and use of tissue and organs from the deceased, and the storage and use of tissue from the living. Part 1 removal, storage and use of human organs and other tissue for scheduled purposes. The human transplantation wales act 20 these laws ensure human tissue is used safely and ethically, with appropriate consent. This guide gives an overview of our legislation and explains common terms found in the act. 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 act repeals the following acts in england and wales. It repealed and replaced the human tissue act 1964.
The act was brought about as a consequence of, among things, the alder hey organs scandal, in which organs of. 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. Person collecting or using tissue must take into account cultural and spiritual needs, values, and beliefs. What links here related changes upload file special pages permanent link page. The human tissue act 2004 c 30 is an act of the uk parliament applying to england, northern. The ht act established the human tissue authority hta to regulate activities concerning the removal, storage, use and disposal of human tissue. To be completed by the person making the donation please complete in block capitals. 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. But on closer inspection a more complex position emerges. It gives the attorney general and human rights commissioner some powers to intervene in courts and tribunals where human rights are concerned, and gives the supreme court the power to declare territory laws.
The human tissue authority hta issues licences based on postcode and each licence is supervised by a designated individual. A uk government watchdog that supports public confidence by licensing organisations that store and use human tissue for purposes such as research, patient treatment, postmortem examination, teaching and public exhibitions. Human tissue act university hospitals plymouth nhs trust. Human tissue authority annual report and accounts 200809 chief executives report remit and functions the human tissue authority hta was established on 1 april 2005 under the human tissue act 2004 ht act to regulate the removal, storage, use and disposal of human tissue in england, wales and northern ireland. The human tissue act was passed by parliament on 15th november 2004. Human tissue act 2004 definition of human tissue act. It will make consent the fundamental principle underpinning the lawful storage and use of human bodies, body parts, organs and tissue and the. Changes that have been made appear in the content and are referenced with annotations. Revised legislation carried on this site may not be fully up to date. The human tissue act 2004 c 30 is an act of the uk parliament applying to england, northern ireland and wales. The htwg, supported by the research governance team, advises on and oversees university processes and procedures to ensure compliance with. Human tissue act 1983 no 164 new south wales historical version for 1.
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 the act focuses on both consent and licensing making consent fundamental to the removal, storage and use of human tissue for certain scheduled. The human tissue act 2004 hta sets up two requirements for the conduct of research on relevant material. Code of practice and standards human tissue authority. There is separate legislation in scotland the human tissue scotland act 2006. Aug 30, 2006 the human tissue act comes into force on 1 september, but what is it and how will it work. The human tissue act 2004 sets out a legal framework in england, wales and northern ireland for the storage and use of human tissue from the living and for the removal, storage and use of human tissue and organs from the dead. The human rights act 2004 is a law which recognises and describes the fundamental civil and political rights that individuals have. The human tissue act 2004 creates a new offence of dna theft. It regulates the removal, storage, use and disposal of human bodies, organs and tissue for a number of scheduled purposes such as research, transplantation, and education and training.
Introduction to the human tissue authority codes of practice. The human tissue act 2004 ht act repeals and replaces the human tissue act 1961, the anatomy act 1984 and the. The htwg, supported by the research governance team, advises on and oversees university processes and procedures to ensure compliance with requirements of the ht act and the regulations. The human tissue act 2004, anatomical examination and the. The human tissue act 2004 repeals the human tissue act 1961, the anatomy act 1984 and the human organ transplants act 1989. The new act, which repeals and replaces the human tissue act 1961, the anatomy act 1984, and the. An act to make provision with respect to activities involving human tissue. The royal society has warned the uk government that continuing to ignore the concerns of the scientific community over the proposed human tissue bill could cut off vital avenues of research into understanding disease. Human tissue act 1961, anatomy act 1984 and human organ transplants act 1989 as they relate to england and wales. The human tissue act 2004 regulates the removal, storage and use of human tissue. Human tissue act 2008 no 28 as at 01 october 2018, public. The human tissue act 2004 replaced 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. Legal decision making a christian perspective ebenezer laryea university of southampton introduction ince the days of my early days, i have maintained a cleareyed opinion about.
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