Weighing the moral status of brain organoids and research animals.

Recent advances in human brain organoid systems have raised serious worries about the possibility that these in vitro 'mini-brains' could develop sentience, and thus, moral status. This article considers the relative moral status of sentient human brain organoids and research animals, examining whether we have moral reasons to prefer using one over the other. It argues that, contrary to common intuitions, the wellbeing of sentient human brain organoids should not be granted greater moral consideration than the wellbeing of nonhuman research animals. It does so not by denying that typical humans have higher moral status than animals, but instead by arguing that none of the leading justifications for granting humans higher moral status than nonhuman animals apply to brain organoids. Additionally, it argues that there are no good reasons to be more concerned about the well-being of human brain organoids compared to those generated from other species.

Consent-GPT: is it ethical to delegate procedural consent to conversational AI?

Obtaining informed consent from patients prior to a medical or surgical procedure is a fundamental part of safe and ethical clinical practice. Currently, it is routine for a significant part of the consent process to be delegated to members of the clinical team not performing the procedure (eg, junior doctors). However, it is common for consent-taking delegates to lack sufficient time and clinical knowledge to adequately promote patient autonomy and informed decision-making. Such problems might be addressed in a number of ways. One possible solution to this clinical dilemma is through the use of conversational artificial intelligence using large language models (LLMs). There is considerable interest in the potential benefits of such models in medicine. For delegated procedural consent, LLM could improve patients' access to the relevant procedural information and therefore enhance informed decision-making.In this paper, we first outline a hypothetical example of delegation of consent to LLMs prior to surgery. We then discuss existing clinical guidelines for consent delegation and some of the ways in which current practice may fail to meet the ethical purposes of informed consent. We outline and discuss the ethical implications of delegating consent to LLMs in medicine concluding that at least in certain clinical situations, the benefits of LLMs potentially far outweigh those of current practices.

Should AI allocate livers for transplant? Public attitudes and ethical considerations.

BACKGROUND: Allocation of scarce organs for transplantation is ethically challenging. Artificial intelligence (AI) has been proposed to assist in liver allocation, however the ethics of this remains unexplored and the view of the public unknown. The aim of this paper was to assess public attitudes on whether AI should be used in liver allocation and how it should be implemented. METHODS: We first introduce some potential ethical issues concerning AI in liver allocation, before analysing a pilot survey including online responses from 172 UK laypeople, recruited through Prolific Academic. FINDINGS: Most participants found AI in liver allocation acceptable (69.2%) and would not be less likely to donate their organs if AI was used in allocation (72.7%). Respondents thought AI was more likely to be consistent and less biased compared to humans, although were concerned about the "dehumanisation of healthcare" and whether AI could consider important nuances in allocation decisions. Participants valued accuracy, impartiality, and consistency in a decision-maker, more than interpretability and empathy. Respondents were split on whether AI should be trained on previous decisions or programmed with specific objectives. Whether allocation decisions were made by transplant committee or AI, participants valued consideration of urgency, survival likelihood, life years gained, age, future medication compliance, quality of life, future alcohol use and past alcohol use. On the other hand, the majority thought the following factors were not relevant to prioritisation: past crime, future crime, future societal contribution, social disadvantage, and gender. CONCLUSIONS: There are good reasons to use AI in liver allocation, and our sample of participants appeared to support its use. If confirmed, this support would give democratic legitimacy to the use of AI in this context and reduce the risk that donation rates could be affected negatively. Our findings on specific ethical concerns also identify potential expectations and reservations laypeople have regarding AI in this area, which can inform how AI in liver allocation could be best implemented.

The Parliamentary Inquiry into Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 in Australia: A Qualitative Analysis.

Recently, Australia became the second jurisdiction worldwide to legalize the use of mitochondrial donation technology. The Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 allows individuals with a family history of mitochondrial disease to access assisted reproductive techniques that prevent the inheritance of mitochondrial disease. Using inductive content analysis, we assessed submissions sent to the Senate Committee as part of a programme of scientific inquiry and public consultation that informed drafting of the Bill. These submissions discussed a range of bioethical and legal considerations of central importance to the political debate. Significantly, submissions from those with a first-hand experience of mitochondrial disease, including clinicians and those with a family history of mitochondrial disease, were in strong support of this legislation. Those in support of the Bill commended the two-staged approach and rigorous licencing requirements as part of the Bill's implementation strategy. Submissions which outlined arguments against the legislation either opposed the use of these techniques in general or opposed aspects of the implementation strategy in Australia. These findings offer a window into the ethical arguments and perspectives that matter most to those Australians who took part in the Senate inquiry into mitochondrial donation. The insights garnered from these submissions may be used to help refine policy and guidelines as the field progresses.

Response to the ISSCR guidelines on human-animal chimera research.

The International Society for Stem Cell Research (ISSCR) has recently released the 2021 update of its guidelines. The update includes detailed new recommendations on human-animal chimera research. This paper argues that the ISSCR recommendations fail to address the core ethical concerns raised by neurological chimeras-namely, concerns about moral status. In minimising moral status concerns, the ISSCR both breaks rank with other major reports on human-animal chimera research and rely on controversial claims about the grounds of moral status that many people will rightly reject. A more robust framework for regulating human-animal chimera research still needs to be developed.

Ethical implementation of mitochondrial donation in Australia.

Australia has recently legalised mitochondrial donation. However, key ethical and legal issues still need to be addressed. This paper maps the relevant issues and offers some suggestions for how they ought to be resolved.

Ethics of Buying DNA.

DNA databases have significant commercial value. Direct-to-consumer genetic testing companies have built databanks using samples and information voluntarily provided by customers. As the price of genetic analysis falls, there is growing interest in building such databases by paying individuals for their DNA and personal data. This paper maps the ethical issues associated with private companies paying for DNA. We outline the benefits of building better genomic databases and describe possible concerns about crowding out, undue inducement, exploitation, and commodification. While certain objections deserve more empirical and philosophical investigation, we argue that none currently provide decisive reasons against using financial incentives to secure DNA samples.

Moving from 'fully' to 'appropriately' informed consent in genomics: The PROMICE framework.

Genomic sequencing technologies (GS) pose novel challenges not seen in older genetic technologies, making traditional standards for fully informed consent difficult or impossible to meet. This is due to factors including the complexity of the test and the broad range of results it may identify. Meaningful informed consent is even more challenging to secure in contexts involving significant time constraints and emotional distress, such as when rapid genomic testing (RGS) is performed in neonatal intensive care units. In this article, we propose that informed consent matters not for its own sake, but because obtaining it furthers a range of morally important goals, such as promoting autonomy, well-being, and trust in medicine. These goals form the basis of a new framework [PROmoting Morally Important Consent Ends (PROMICE)] for assessing the ethical appropriateness of various informed consent models. We illustrate this framework with two examples: (a) a tiered and layered consent model for obtaining consent for GS, and (b) consent for RGS in critically ill newborns. We conclude that appropriately-rather than fully-informed consent provides the correct standard for genomic medicine and research.

Ethical Issues in Commercialisation of Stem Cell Therapies: Mapping the Terrain.

Bioethical debates on stem cell research have focused primarily on the moral status of human embryos. This article highlights seven distinct policy and ethical issues associated with the commercialisation of stem cell therapies, describes some of the underlying moral questions on which they turn, and argues that there is an urgent need to refocus the debate on stem cell research beyond the controversy over embryo destruction.

The Moral Superiority of Bioengineered Wombs and Ectogenesis for Absolute Uterine Factor Infertility.

This paper argues that uterine transplants are a potentially dangerous distraction from the development of alternative methods of providing reproductive options for women with absolute uterine factor infertility (AUFI). We consider two alternatives in particular: the bioengineering of wombs using stem cells (which would carry fewer risks than uterine transplants) and ectogenesis (which would not require surgical intervention for either the prospective mother with AUFI or a womb donor). Whether biologically or mechanically engineered, these womb replacements could provide a way for women to have children, including genetically related offspring for those who would value this possibility. Most importantly, this alternative would avoid the challenge of sourcing wombs for transplant, a practice that we argue would likely be exploitative and unethical. Continued research into bioengineering and ectogenesis will therefore remain morally important despite the recent development of uterine transplantation, even if the procedure reaches routine clinical application.

Lessons from Frankenstein 200 years on: brain organoids, chimaeras and other 'monsters'.

Mary Shelley's Frankenstein has captured the public imagination ever since it was first published over 200 years ago. While the narrative reflected 19th-century anxieties about the emerging scientific revolution, it also suggested some clear moral lessons that remain relevant today. In a sense, Frankenstein was a work of bioethics written a century and a half before the discipline came to exist. This paper revisits the lessons of Frankenstein regarding the creation and manipulation of life in the light of recent developments in stem cell and neurobiological research. It argues that these lessons are becoming more relevant than ever.

Old Challenges or New Issues? Genetic Health Professionals' Experiences Obtaining Informed Consent in Diagnostic Genomic Sequencing.

BACKGROUND: While integrating genomic sequencing into clinical care carries clear medical benefits, it also raises difficult ethical questions. Compared to traditional sequencing technologies, genomic sequencing and analysis is more likely to identify unsolicited findings (UF) and variants that cannot be classified as benign or disease-causing (variants of uncertain significance; VUS). UF and VUS pose new challenges for genetic health professionals (GHPs) who are obtaining informed consent for genomic sequencing from patients. METHODS: We conducted semi-structured interviews with 31 GHPs across Europe, Australia and Canada to identify some of these challenges. RESULTS: Our results show that GHPs find it difficult to prepare patients to receive results because a vast amount of information is required to fully inform patients about VUS and UF. GHPs also struggle to engage patients - many of whom may be focused on ending their 'diagnostic odyssey' - in the informed consent process in a meaningful way. Thus, some questioned how 'informed' patients actually are when they agree to undergo clinical genomic sequencing. CONCLUSIONS: These findings suggest a tension remains between sufficient information provision at the risk of overwhelming the patient and imparting less information at the risk of uninformed decision-making. We suggest that a shift away from 'fully informed consent' toward an approach aimed at realizing, as far as possible, the underlying goals that informed consent is meant to promote.

Emerging moral status issues.

Many controversies in bioethics turn on questions of moral status. Some moral status issues have received extensive bioethical attention, including those raised by abortion, embryo experimentation, and animal research. Beyond these established debates lie a less familiar set of moral status issues, many of which are tied to recent scientific breakthroughs. This review article surveys some key developments that raise moral status issues, including the development of in vitro brains, part-human animals, "synthetic" embryos, and artificial womb technologies. It introduces the papers in this Special Issue, contextualises their contributions to the moral status literature, and highlights some enduring challenges of determining the moral status of novel types of beings.

'It's not worse than eating them': the limits of analogy in bioethics.

Bioethicists often defend novel practices by drawing analogies with practices that we are already familiar with and currently tolerate. If some novel practice is less bad than some widely-accepted practice, then (it is argued) we cannot rightly reject it. Using the bioethics literature on xenotransplantation and interspecies blastocyst complementation as a case study, I show how this style of argument can go awry. The key problem is that our moral intuitions about familiar practices can be distorted by their seeming normality. When considering the ethics of emerging technologies and novel practices, we should remain open to the possibility that our moral views about familiar practices are mistaken.

The Duty to Look for Incidental Findings in Imaging Research.

Imaging research regularly yields incidental findings that may have personal medical or reproductive decision-making significance to study participants. It is widely assumed that researchers have a moral obligation to disclose at least some kinds of incidental findings to research participants. However, it is also a widely held view that researchers do not have a moral obligation to actively look for abnormalities irrelevant to the aims of their study. This paper challenges that assumption.