Organ Donation and Transplantation

Author(s):  
Keith Rigg

The organ donation and transplantation sector in the UK has a comprehensive legal and regulatory framework, with some important differences between England, Scotland, Wales, and Northern Ireland. The Human Tissue Act 2004 and the Human Tissue (Scotland) Act 2006 are the key pieces of primary legislation, with the Human Tissue Authority being the regulatory authority. Consent, or authorization in Scotland, is the golden thread that runs through the legislation and is key for the removal, storage, and use of organs for transplantation. The specific aspects of the legislation that cover deceased donor transplantation are: (1) consent/authorization; (2) when the wishes of the deceased take precedence; and (3) preservation of organs for transplantation whilst awaiting consent. For living donor transplantation, the legislation governs: (1) the regulations pertaining to all living donor transplantation; (2) paired/pooled donation; (3) non-directed stranger donation; and (4) the illegality of commercial dealings in human organs.

Medical Law ◽  
2019 ◽  
pp. 625-690
Author(s):  
Emily Jackson

All books in this flagship series contain carefully selected substantial extracts from key cases, legislation, and academic debate, providing students with a stand-alone resource. This chapter discusses organ transplantation. It first considers cadaveric donation, looking at who may become a donor, and which organs can be taken. It also includes discussion of the issues raised by novel transplants, like face and uterus transplantation. The chapter summarizes the system of organ retrieval in the UK, looking at the consent-based model adopted in the Human Tissue Act 2004; the introduction of an opt-out system in Wales, and the government’s plan to introduce a similar system in England. It then turns to living organ donation, looking at informed consent and the legitimacy, or otherwise, of incentives. Finally, it considers the ethical, practical, and legal obstacles to xenotransplantation, i.e. transplanting animal organs into human recipients.


2021 ◽  
Vol 23 (3) ◽  
pp. 245-247
Author(s):  
Steve Philpot ◽  
◽  
David Anderson ◽  
◽  
◽  
...  

The Human Tissue Act 1982 (Vic) has recently been amended by the Human Tissue Amendment Act 2020(Vic). In an effort to better reflect the modern practice of organ donation, the intention of the amendment is to include a process for the authorisation of ante-mortem procedures in patients being considered for organ donation after circulatory determination of death(DCDD). As part of this process, the amendment introduces a new requirement for consent for such ante-mortem procedures, and specifies that: A designated officer for a hospital must not give an authority … in respect of a person unless, where the respiration or the circulation of the blood of the person is being maintained by artificial means, two registered medical practitioners, neither of whom is the designated officer and each of whom has been for a period of not less than five years a registered medical practitioner, have each certified in writing — ​ that the practitioner has carried out a clinical examination of the person while the respiration or the circulation of the blood of that person was being maintained by artificial means; and that, in the practitioner’s opinion, at the time of examination, death of the person would occur as a result of the withdrawal of the artificial means of maintaining the respiration or the circulation of the blood of the person.


2005 ◽  
Vol 12 (1) ◽  
Author(s):  
Gillian Johnson ◽  
Alex Wilson

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 Human Tissue Act 2004 is due to come into force in April 2006 and will resolve a number of uncertainties for researchers. The adopted regulatory approach is not dissimilar to that adopted for the use of embryos in the UK. The legislation provides the framework but a body established under the Act – the Human Tissue Authority (HTA) – will be responsible for granting licences, determining what constitutes 'appropriate consent' and providing detailed guidance and regulations. The advantage of this approach is that it will allow the board of the HTA, whose members include experienced professionals in the medical and research communities, to adapt the system to keep up with scientific developments and possibly changes in public opinion more rapidly than would have been possible where guidance is set out within the legislation. Even before the HTA issues its first guidance, researchers can be clear that certain activities, such as those relating to cell lines, are not covered by the Act. Other processes, such as the anonymising and de-linking of patient data could be subject to additional regulation by the HTA although any guidelines must also conform with the provisions of the Data Protection Act 1998. This paper discusses the new regulatory framework and identifies the challenges for researchers in complying with an Act, which provides for criminal sanctions for breach.


2006 ◽  
Vol 2 (1) ◽  
pp. 10-14
Author(s):  
P. A. Carson ◽  
J. Holt ◽  
M. McGrady

The cosmetics, detergents and food industries trial development products using healthy human volunteer studies. They also use human tissue for in vitro investigations. Hitherto, the ethics of such work has not been regulated. The UK Human Tissue Act will have legal implications on current arrangements for such studies within the industry, especially with regards to informed consent and seeking ethical review of research proposals. At present, however, it is unclear who will fund ethical review for use of ‘relevant material’ in non-medical research, and on the required status of ethics committees to review such work. The principles behind the sampling, storage and processing of ‘relevant material’ are largely identical whether it be for medical or non-medical investigations. It is argued, therefore, that this is further justification for industry and professional bodies to adopt best practice of ethical review for all studies in ‘grey areas’ outside the scope of regulations. This would follow closely those standards applied to biomedical research.


2021 ◽  
pp. 114-133
Author(s):  
Jo Samanta ◽  
Ash Samanta

This chapter deals with statutory provisions governing human tissue and organ transplantation, with particular reference to the Human Tissue Act 2004. It first considers the position at common law with regards to property in the human body, followed by a discussion of appropriate consent given by potential donors prior to their death or by deceased donors. It also considers the change in law to presumed consent under the Organ Donation (Deemed Consent) Act 2019. Organ donation from living persons and ethical issues surrounding organ transplantation are then explored. The chapter concludes by looking at alternative sources of organs, including xenotransplantation and artificial organs. Relevant court cases are cited, where appropriate.


2016 ◽  
Vol 11 (4) ◽  
pp. 122-129 ◽  
Author(s):  
Sarah-Jane Brown

Current organ procurement policies in the UK include ante-mortem interventions to facilitate organ donation. However, a clear and unambiguous legal framework for these procedures does not currently exist. The Human Tissue Act (HTA) 2004 does not provide authority for donor optimisation procedures before death, and there are a number of difficulties in encompassing these procedures within the Mental Capacity Act (MCA) 2005 provisions on best interests. This article proposes a system of specific advance consent to enable best interests to take on its ascribed role as the legal justification for donor optimisation procedures.


2006 ◽  
Vol 88 (8) ◽  
pp. 264-265 ◽  
Author(s):  
Vishy Mahadevan

The Human Tissue Act 2004 is a new, important, comprehensive and, above all, timely legislation that is due to come into force on 1 September 2006. The act has considerable implications for the practice of anatomy at the College. The significance of these implications cannot be overemphasised, given the imminence of the many and far-reaching changes that are to take place in the nature of postgraduate surgical training in the UK and the fresh demands that the new training schemes will impose on the delivery of effective postgraduate surgical education (in particular, surgical anatomy).


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