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.

From Beyond the Grave: Use of Medical Information from the Deceased to Guide Care of Living Relatives

Purpose of Review In order to inform patients of their genetic risks, access to the medical records and/or stored samples of their relatives is often helpful. We consider some of the obstacles to such access when these relatives are deceased and suggest how they might be navigated. Recent Findings We explore an issue first highlighted in 2004 by Lucassen et al. (Br Med J 328:952–953, 2004) and re-evaluate it in the wake of novel technologies and mainstreaming of genomic medicine. We find that it is still an issue in practice despite professional guidelines advocating access to familial information (Joint Committee on Genomics in Medicine 2019) and that the Human Tissue Act 2004 is often wrongly constructed as a reason to block access. Access is often obstructed by failing to adopt the necessary relational concept of autonomy that applies in genetic medicine as reported by Horton and Lucassen (Curr Genet Med Rep 7:85–91, 2019) and by considering confidentiality to be absolute, even after death. In response to a recent legal case about the confidentiality of genetic test results, and their disclosure to family members (ABC v St George’s Healthcare NHS Trust 2020), Dove et al. (J Med Ethics 45:504–507, 2019) suggested that a duty to consider the interests of genetic relatives could co-exist alongside a duty of confidentiality to a patient. In this way, healthcare professionals can use professional judgement about the relative value of genetic information to family members. This is equally relevant in accessing deceased relatives’ information. A recent systematic review found a high level of acceptability of postmortem use of genetic data for medical research amongst participants and their relatives, and it is reasonable to assume that this acceptability would extend to clinical practice as reported by Bak et al. (Eur J Hum Genet 28:403–416, 2020). Summary Within clinical practice, access to medical records/samples of deceased relatives is often obstructed unnecessarily, potentially resulting in harm to the living relatives seeking advice. Consent to such access is important but need not be the bureaucratic hurdle that is often imposed.

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.