Discussion document how to have your say your feedback is important in helping to develop the guidelines on the use of human tissue for future unspecified research purposes. The human tissue act 2004 c 30 is an act of the uk parliament applying to england, northern ireland and wales. Subsidiary legislation made under this act current versions. It established the hta to regulate activities concerning the removal. While providing a welcome and timely revision of the now outdated human tissue act of 1961, the newly introduced human tissue bill of 2004 contains a number of anomalies in its drafting that threaten to undermine its effectiveness in practice. Human tissue bill comment from the royal society on specific issues of concern 16 february 2004 the lack of distinction between various types of tissue sample that may be retained one major failing of the legislation is not distinguishing between different types of human. The act was brought about as a consequence of, among things, the alder hey organs scandal, in which organs of. The human tissue act 2008 was passed in april 2008 and came into force on 1 november 2008. Different consent requirements apply when dealing with. The human tissue act 2004 regulates the removal, storage and use of human tissue. Explanatory notes were introduced in 1999 and accompany all public acts except appropriation, consolidated fund, finance and consolidation acts.
These late 1980s and early 1990s events had occurred whilst these babies were undergoing heart surgery. A uk parliamentary act which made provision with respect to the use of parts of bodies of deceased persons for therapeutic purposes and purposes of medical education and research, and with respect to the circumstances in which postmortem examinations could be carried out, and permitted the cremation of bodies removed. Return one copy to the bequest office, centre for comparative and clinical anatomy, university of bristol. As i have said before, the penalties are there to act as a deterrent to future misuse of human tissue and we do not expect cases to 400 come to court. The ultra uk agency and the post of hm inspector of anatomy were abolished and their functions transferred to the authority. 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. On 1 september 2006, the legislation relating to organ donation within the uk changed. Only the most serious cases would warrant a custodial sentence and this will now be following a trial by jury. 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 hta was established by the human tissue act 2004 the act. In this commentary, we look at the legislation in terms of anatomical teaching and in doing so raise awareness of the importance of body bequeathal to medical teaching. The human tissue authority hta issues licences based on postcode and each licence is supervised by a designated individual.
The role of hta in regulating research under the human tissue act 2004 9. At first glance it may appear to set many of the concerns raised in the bristol interim inquiry and alder hey inquiry to rest. During the spring sitting of parliament last year the government introduced the human tissue amendment bill. 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 national code includes a set of principles that act as guidelines for the conduct of coronial and noncoronial autopsies. The human tissue act 2004 creates a new offence of dna theft. The type of research regulated by the hta under the ht act usually takes the form of laboratory bench research. Inspectors of the same school of anatomy may combine their reports, or report. Human tissue act 1982 human tissue regulations 2006 the governor in council makes the following regulations. The telephone number for general enquiries is 020 7219 8675. The human tissue act 2004 new legislation on human organs and tissue what is the human tissue act 2004. The human assisted reproductive technology act 2004 prohibits the sale and purchase of gametes and embryos all member states of the eu adhere to the.
How act applies to foetal tissue not subject to code. Human tissue and transplant act 1982 western australia. Human tissue and anatomy legislation amendment act 2003. Human tissue and anatomy legislation amendment act 2003 no 18 new south wales an act to amend the anatomy act 1977,thehuman tissue act 1983 and other acts to make further provision with respect to the removal, retention and use of human tissue, postmortem examinations and anatomical examinations. Changes that have been made appear in the content and are referenced with annotations. New staff introduction to the human tissue act 2004. Research use of an existing collection of human samples. In the most recent legislation the focus is on relevant material m aterial which has come from a human body and consists of, or includes, human.
However, as mentioned above it is still important to. But on closer inspection a more complex position emerges. There is separate legislation in scotland the human tissue scotland act 2006. Human tissue act 2004 is up to date with all changes known to be in force on or before 19 july 2019. Guidelines on the use of human tissue for iii future unspecified research purposes. There are changes that may be brought into force at a future date. The introduction of the human tissue ht act 2004,1 which was implemented in september 2006 in the uk, can be understood as a response to concerns raised by events at bristol royal infirmary, the royal liverpool childrens hospital and elsewhere, where organs and tissue from children who had died were removed and stored without proper consent. Sale and purchase of tissues group 16 authorstream presentation. Objectives the objectives of these regulations are to prescribe a institutions within which authorised schools. European convention on human rights the lord warner has made the following statement under section 191a of the human rights act 1998.
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. I have read and understood the information both on the attached sheet and the mentioned website links and understand the implications of the hta. Act of 1961, the newly introduced human tissue bill of 2004 contains a number of anomalies in its drafting that threaten to undermine its effectiveness in practice. The human tissue act 2004 repeals the human tissue act 1961, the anatomy act 1984 and the human organ transplants act 1989. The human tissue act 2004, anatomical examination and. This section has in view directive 2004 23ec of 31 march 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, which is due to be implemented by 7 april 2006. It consolidates previous legislation and created the human tissue authority to regulate the removal, storage, use and disposal of human bodies, organs and tissue. 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 2004 hta 2004 was introduced to address serious concerns raised in the course of the 1998 kennedy inquiry. Bronwyn pike minister for health ruth leach clerk of the executive council 1. The power in this section will allow any necessary amendments to be made. The ht act established the human tissue authority hta to regulate activities concerning the removal, storage, use and disposal of human tissue. The hta was established under the human tissue act 2004 with the aim of maintaining public. Material transfer agreement for data andor samples dear sir madam.
The htwg, supported by the research governance team, advises on and oversees university processes and procedures to ensure compliance with. 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. The human tissue act 2004 covers england, wales and northern ireland. Human tissue amendment bill 2006 brought in by the minister for health and human services, the honourable larissa tahireh giddings a bill for an act to amend the human tissue act 1985 be it enacted by his excellency the governor of tasmania, by and with the advice and consent of the legislative council and. Human tissue and anatomy legislation amendment bill.
Second reading mr knowles macquarie fields minister for health 10. The human tissue act is available from the victorian legislation and parliamentary documents website. New staff introduction to the human tissue act 2004 history and keele university guidelines. Human tissue act 2004, part 1 is up to date with all changes known to be in force on or before 12 july 2019. The enactment of the human tissue act 2004 has had a significant impact.
Human tissue and transplant act 1982 an act to make provision for and in relation to the removal of human tissues for transplantation, other therapeutic purposes, or medical or scientific purposes, for postmortem examinations, for the repeal of the tissue grafting and processing act 1956, the sale of. 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. Person collecting or using tissue must take into account cultural and spiritual needs, values, and beliefs. The health act 1956 prohibits trade in blood and blood products. A guide for the public to the human tissue act 2004 this guide is intended to be read alongside the human tissue act 2004. The implications of the human tissue act 2004 james lawford. The human tissue act received royal assent on 15 november 2004. Historically, in the uk, the use of certain body parts has been regulated by human tissue acts, thus the phrase generally describes that area of legal regulation.
Part 1 removal, storage and use of human organs and other tissue for scheduled purposes. Contacts for joint committee on the human tissue and embryos draft bill all correspondence should be addressed to the clerk, joint committee on the human tissue and embryos draft bill, committee office, house of lords, london sw1a 0pw. Consent is the fundamental principle of the legislation and underpins the lawful removal, storage and use of body parts, organs and tissue. In my view the provisions of the human tissue bill are compatible with the convention rights. Three hypothetical scenarios are then used to draw out the implications of these principles for existing regulatory policy and the common law response to excised human organs. Human tissue act 1961 definition of human tissue act. It established the hta to regulate activities concerning the removal, storage, use and disposal of human tissue. This guide gives an overview of our legislation and explains common terms found in the act. Person justified in deciding not to collect or use tissue. The human tissue working group htwg was established to consider all aspects of the hta licensing requirements. Under the terms of the human tissue act, waht and the university of bristol are corporate licence holders. Human tissue act 2004, which grant the donor a form of proprietary control.
These late 1980s and early 1990s events had occurred. 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. 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. To ascertain if the human tissue act 2004 is relevant and if so. If prior to 1st september 2006, the collection is an existing holding and the requirements of the human tissue scotland act 2006 do not apply for research. Versions of this act includes consolidations, reprints and as passed versions.
Human tissue act 2004, section 8 is up to date with all changes known to be in force on or before 07 february 2020. Text created by the government department responsible for the subject matter of the act to explain what the act sets out to achieve and to make the act accessible to readers who are not legally qualified. 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. Research involving storage and use of human tissue. This is defined as material that has come from a human body and consists of, or includes, human cells. Material transfer agreement for data andor samples. Code of practice and standards human tissue authority. Some regulatory acts for sale and purchase of human tissue. 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.
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