This article offers a critique of the concept of ‘abandonment’ when utilized in relation to separated human biomaterials. In the absence of the recognition of even limited property rights in the human source of such materials, the author contends that utilizing abandonment is meaningless and misleading. Absurd consequences need not result from recognition of such rights and indeed most cases of purported abandonment of human tissue are more akin to voluntary transfers. Describing such transfers in terms of abandonment obscures questions as to the agency and the scope of the fiduciary duties of medical professionals and researchers. Income rights in such materials are more appropriately determined as normative questions as to who should benefit from windfall wealth in human biomaterials, not by reference to abandonment. An alternative framework that recognized that the source of human tissue had limited property rights in it would solve many of the conceptual difficulties outlined.
Induced pluripotent stem cells (iPSCs) have been presented as a more ethical alternative to human embryonic stem cells (hESCs), which are surrounded by a significant ethical controversy. This article discusses some potential promises and perils of iPSCs for regenerative medicine. It also presents some ethical perspectives regarding the hypothetical use of iPSCs in reproductive applications. In particular, this article analyses whether iPSCs are a less problematic alternative to hESCs from an ethical viewpoint. In order to shed some light on this multidimensional question, the prospects of iPSCs for regenerative medicine will be discussed in light of the current scientific knowledge. In addition, paradoxical linkages between iPSC and hESC technologies will be analysed from a bioethical perspective. Finally, legal and ethical patentability considerations affecting the commercialization prospects of different pluripotent stem cell-based products will be discussed.
Abortion is considered by some to be a morally questionable intervention, one which entitles the healthcarer to exercise conscientious objection (CO) so as to opt out of acting. The healthcarer’s right to do so was recently considered by the UK Supreme Court (UKSC) in Greater Glasgow Health Board v. Doogan and Wood, a case which set some boundaries on CO but which failed to engage holistically with the foundation of CO and its position relative to the competing right to adequate healthcare, a failure which must be seen as a lost opportunity given the manifold threats to timely access to abortion. This article fills the lacunae. After noting the weaknesses in the Doogan judgement, it justifies the adoption of a more robust approach by the UKSC, and then analyses the moral and rights foundations of abortion and CO, noticing as it does the growing practical problem that is the expansion and misuse of CO in women’s health (i.e. its deployment as a barrier to women seeking lawful abortion services). It concludes that courts everywhere, but particularly in jurisdictions that are widely persuasive, such as the United Kingdom, when faced with the opportunity to pronounce on the right to abortion and the operation of CO, should take full advantage, and in doing so, should adopt a critical and restrictive approach to its availability in the healthcare context.
In June 2016, the University of Edinburgh hosted the 13th World Congress (IAB2016) of the International Association of Bioethics (IAB). It is critical both to reflect on the event past and to consider how we might keep future events relevant and to adequately bridge the periods in-between. In other words, how do we generate and maintain legacy and help to keep communities consistently engaged over time? This brief article undertakes these functions by reflecting on some of the lessons learned from IAB2016 in the hope that it will prove useful to future IAB Congress organizers (and indeed other international conference organizers).
Genetic testing can reveal information significant to patients’ relatives. This familial aspect raises an important question: should clinicians owe a duty to disclose genetic risk to patients’ blood relations? In ABC v. St George’s Healthcare NHS Trust and Smith and Another v. University of Leicester NHS Trust, the High Court rejected claims by relatives regarding genetic information. Both cases are being appealed. The High Court’s analysis of duty was restrictive; foreseeable harm and proximity thus far receiving minimal scrutiny. A detailed analysis indicates harm and proximity are important in defining the scope of a duty. The foreseeable harm is argued as medically actionable genetic conditions. Proximity could be demonstrated by claimants establishing themselves as identifiable victims of non-disclosure that ought to be in defendants’ contemplation as so affected. It is also argued a duty is not prohibited by the policy reasons relied upon in ABC: incremental development, confidentiality, a right not to know and psychiatric harm.
Whether living tissue and donation by minors is acceptable is the subject of considerable debate. In view of the vulnerable position of minors, the risks involved in the medical procedure, and the possible conflict of interests on the part of the parents, the legal approach in Europe has traditionally been very restrictive. However, this approach may raise concerns when a situation would arise where donation by a minor would still be in that person’s best interests. Moreover, a very restrictive approach may be difficult to reconcile with the requirement to give due weight to the views of minors in accordance with their age and maturity. In the light of these considerations, this article examines whether there is room to improve the way in which living tissue and organ donation by minors is currently regulated across Europe. We first sketch the debate about the acceptability of using minors as living donors and explore its potential clinical need. Subsequently, we assess whether international legal instruments and guidelines offer any guidance to address the issues raised. This is followed by an analysis of the legal situation in the United States. Finally, we examine in detail the legal situation in Europe. To that aim, relevant regulations were compiled, translated, and analyzed in close cooperation with national legal experts. By way of conclusion, we compare the legal approach followed in the great majority of European countries with the one preferred in the United States and make suggestions to amend European transplant regulations to better protect the interests of minors.
In this contribution, the "Guide on the decision-making process regarding medical treatment in end-of-life situations" published by the Committee on Bioethics of the Council of Europe has been analyzed by taking into consideration different perspectives, such as medical, ethical, and legal views. In this commentary, reasons why this guide should be applied not only by the care team but also by patients, his or her family, relatives, or legal proxies have been examined. In addition, some argumentations why this guide should also include physician-assisted suicide and euthanasia have been explained. The application of ethical principles and the balance between the patient’s right to self-determination and the physician’s duty of care have been studied under the general principle of fair distribution of public recourses in palliative care. Moreover, some examples from national legislations of some Western European countries have been given to illustrate and support these guidelines.
Authorities responsible for regulating medicines and other medical products continue to expand opportunities for direct participation of patients and their representatives in regulatory processes. For example, patient representatives can participate as members of scientific committees and provide input in various ways. This article examines the current framework and recent initiatives for such participation in the US Food and Drug Administration and European Medicines Agency. It draws on scholarship on public and patient participation in other contexts to describe and clarify the purposes and roles of patient involvement and to identify issues needing attention in the development of these initiatives, including systemic factors that may impede the ability of patient representatives to fulfill their roles effectively. It considers convergent efforts to engage patients in research and development that could alleviate some of these difficulties and provide an opportunity to rethink the goals and methods of patient involvement in a larger context.
In ABC v. St Georges Healthcare NHS Trust, the High Court rejected the argument that doctors have a legal duty to disclose actionable genetic risks to a patient’s relatives. This article reconsiders the concept of a duty to disclose actionable genetic risks in the context of widening perceptions of legal harm and developing professional and public perceptions of corresponding wrongs.
This commentary considers the decision of the Supreme Court (SC) in Greater Glasgow Health Board v. Doogan and Others, which concerns the definition of ‘participate’ in the context of abortion and the conscientious objection of healthcare professionals due to their religious beliefs. It is argued that the SC was correct in affirming the definition of participate as articulated by Lord Keith in Janaway v. Salford Area General Authority. The protection of conscientious objection, under Article 9 of the European Convention on Human Rights, is considered. The discussion in this commentary, however, is limited to religious belief and does not consider the wider ambit of Article 9, such as nonreligious philosophical beliefs.
If the central purpose of non-invasive prenatal testing (NIPT) is to deliver improved reproductive autonomy – by facilitating enhanced choice between the continuation and termination of pregnancy – any public-funded regime ought to be compatible with the legal grounds for decision-making in this context. It is problematic for a State to facilitate access to information that would or is likely to result in legal dilemmas and conceptual issues for those using these tests. Public-funded testing should not be available for purposes that would be or are likely to be ‘incompatible’ with any framework for lawful abortion. In England and Wales, those incompatible purposes currently include the identification of (1) gender in the absence of other genetic factors and (2) specific abnormality that is unlikely to yield serious disability at birth. Consequently, expansion of the NIPT regime to include these purposes should entail changes in the legal framework for abortion.
With the progress in bioinformatics, genomics, and epidemiology, biobanks, as repositories of populations’ biological samples as well as of personal and medical information, are becoming an essential research tool. Despite the potential benefits biobanks may bring and the options presented by some of the current biobanks’ consent policies, there remain ethical concerns regarding the autonomy and dignity of research participants if consent is not fully informed as dictated in the terms of traditional informed consent. This article aims at providing an overview of the approaches taken by the main international norms with respect to informed and broad consent and how well these norms are integrated by biobanks or biobank consortia. We conclude that broad consent could be an important tool to achieve the benefits of large-scale biobanks projects. If it is to be accepted, its regulation and implementation need to be mindful of the participant’s dignity and autonomy and sensitive to the need for international coherence and harmonization.