Human Tissue Act 2004

This chapter covers Human Tissue Act 2004 and includes topics on Regulation of Human Tissue, Human Tissue: Consent by Children, Human Tissue: Consent by Adults, Prohibited Activities in relation to Human Tissue, Restrictions on Donated Human Tissue, Restrictions on donations using life transplants, and Prohibition of commercial dealings in human material for transplantation.

The ethical and legal implications of the Human Tissue Amendment Act 2020 (Vic)

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.

7. Organ transplantation

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.

From ‘Consent or Anonymise’ to ‘Share and Protect’: Facilitating Access to Surplus Tissue for Research Whilst Safeguarding Donor Interests

There is significant research value in the secondary use of surplus human tissue which has been removed during clinical care and is stored in diagnostic archives. However, this value is limited without access to information about the person from whom the tissue was removed. As the research value of surplus tissue is often not realised until after the patient’s episode of care, it is often the case that no consent has been given for any surplus tissue to be used for research purposes. The Human Tissue Act 2004 does permit research use of surplus tissue without consent, but the researcher must not be in possession of information which could identify the person from whom the tissue was removed. Due to the commonly applied ‘consent or anonymise’ approach, linking tissue and data is challenging and full anonymisation would likely render much research on surplus tissue ineffectual. This article suggests that in recognising the value in surplus tissue linked with information about the person, a ‘share and protect’ approach which considers safeguards other than anonymisation, where obtaining consent for research use would not be feasible, would better balance the public benefit of health research with the protection of individual rights and interests than a requirement for either consent or anonymisation.

Midgut cells alteration in gamma-irradiated beetles (Blaps polycresta, Coleoptera: Tenebrionidae)

This study was conducted to examine the effect of gamma radiation on biological specimens. Thus, our concept is to clarify that exposure to accumulated dose of 0.2 Gy gamma rays (0.66 rad/Sec. dose rate) from Cs137 source induces cellular perturbations in the midgut epithelium of the F1 progeny of Blaps polycresta, therefore affecting nutrition and growth. Beetles were reared in laboratory conditions and the newly emerged adults were irradiated with the aforementioned dose. Histological and ultrastructure anomalies of midgut cells (digestive and regenerative cells) were observed by 72 h after radiation exposure to ensure that the cells will not return to control state. Retardation in the development of the F1 progeny was also noticed and beetles died through two weeks. In the light of these observations, biological tissue act as an indicator to the continuous exposure to environmental radiation.

9. Organ Donation and the Ownership of Body Parts

This chapter examines legal and ethical aspects of organ donation and body part ownership. Topics discussed include the Human Tissue Act 2004; liability for mishaps from organ transplant; the shortage of organs for transplant; xenotransplantation; selling organs; face transplants; and the living body as property. Running through this chapter is a discussion of whether it is preferable to see the body and parts of the body as property or whether they need their own system of legal protection through a statute. This debate ties into broader discussions about the nature of the self and what makes bodies valuable.

12. Organ Transplantation

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.

The ‘opt-out’ approach to deceased organ donation in England: A misconceived policy which may precipitate moral harm

In an effort to solve the shortage of transplantable organs, there have been several proposals to introduce an opt-out approach to deceased organ donation in England (also termed ‘deemed’, or ‘presumed’ consent). In seeking to enact the so-called ‘opt-out proposal’ via an amendment to the Human Tissue Act 2004, The Organ Donation (Deemed Consent) Bill 2017–19 represents the most recent attempt at such legal reform. Despite popular calls to the contrary, I argue in this paper that it would be premature for England, or, indeed, any country, to adopt an opt-out approach at this time. Not only is the available evidence inconclusive on whether introduction of the opt-out proposal would increase the supply of transplantable organs (a common misconception), but there is also a chance that doing so might bring about an otherwise avoidable moral harm through an unjustified interference with individual autonomy. I maintain that the resources required to change the law to such effect would be better expended on alternative, provenly efficacious and less contentious mechanisms for increasing the supply of transplantable organs, such as: improving communication with the family of the deceased, developing infrastructure, raising public awareness and enhancing staff training, attitudes and understanding towards organ donation.