Julian Koplin

The clinical development of implantable neural devices raises complex ethical questions about post-trial responsibilities to participants. Continued support for participants who continue to use investigational implantable neural devices requires ongoing specialist care, technical expertise, access to tertiary clinical infrastructure, and substantial financial resources to pay for the device and related procedures. However, continued access may not be possible if the trial shows no benefit, if financial barriers limit commercial viability, or if safety concerns lead to suspension or early termination. Specific ethical guidance on post-trial responsibility is urgently needed. To address this challenge within the Australian innovation context, we conducted a modified Delphi study with a multidisciplinary panel of 24 experts, including representatives from industry, bioethics, law, neurosurgery, clinical psychology/neuropsychology, clinical research, neural engineering, regulation and governance, and lived experience advocacy. The process involved two workshops and a survey, guided by established RAND/UCLA methods with context-specific modifications. Drawing on prior empirical research and regulatory review, the panel developed 11 consensus recommendations for responsible post-trial practices. All recommendations achieved high levels of agreement and were rated as highly important for addressing ethical risks in the Australian environment. These are the first jurisdiction-specific recommendations of their kind, and we anticipate they will substantially enhance ethical and practical standards for post-trial responsibility in implantable neural device research in Australia and internationally.

Human brain organoids (HBOs) are three-dimensional structures derived from human stem cells that model aspects of brain development and function, offering potentially unprecedented opportunities for studying neurological disorders and for developing treatments. This consensus paper presents recommendations from the Asia Pacific Neuroethics Working Group, developed through interdisciplinary collaboration among scientists, bioethicists, philosophers, and legal scholars who convened in Singapore in November 2024. We provide a comprehensive analysis of the ethical, legal, and sociocultural dimensions of HBO research, addressing both current realities and future possibilities. The paper examines key ethical considerations, including the potential moral status of HBOs, particularly regarding sentience and consciousness, while identifying and dispelling common misconceptions and “ethical red herrings” arising from sensationalized portrayals. We analyze consent frameworks for cell donation, privacy concerns, dual-use risks, and questions of distributive justice. Legal challenges are explored, including the categorical ambiguity of HBOs within existing regulatory frameworks, intellectual property issues, and cross-border inconsistencies in standards. Sociocultural perspectives emphasize the importance of public understanding, cross-cultural engagement, and empirical research on diverse community attitudes toward HBO research. In our recommendations, we advocate for evidence-based ethical discussions, anticipatory frameworks addressing potential future developments, contextualized analysis comparing HBOs to related experimental models, robust informed consent processes, proportionate responses to consciousness concerns, development of adaptive regulatory frameworks, responsible science communication to manage public expectations, and sustained interdisciplinary collaboration. We emphasize a balanced approach that promotes scientific innovation while maintaining rigorous ethical oversight, recognizing HBOs’ significant potential for advancing neuroscience and medicine. This represents the first comprehensive ethical framework for HBO research from the Asia Pacific region, helping to establish foundational principles for responsible development of this rapidly advancing field.

Brain organoid research raises ethical challenges not seen in other forms of stem cell research. Given that brain organoids recapitulate the development of the human brain, it is plausible that brain organoids could one day attain consciousness and perhaps even higher cognitive abilities. Brain organoid research therefore raises difficult questions about these organoids’ moral status—questions that currently fall outside the scope of existing regulations and guidelines. This chapter offers a novel moral framework for brain organoid research. It outlines the conditions under which brain organoids might attain moral status and explain what this means for the ethics of experimenting with these entities.

Genomic research can reveal ‘unsolicited’ or ‘incidental’ findings that are of potential health or reproductive significance to participants. It is widely thought that researchers have a moral obligation, grounded in the duty of easy rescue, to return certain kinds of unsolicited findings to research participants. It is less widely thought that researchers have a moral obligation to actively look for health-related findings. This paper examines whether there is a moral obligation, grounded in the duty of easy rescue, to actively hunt for genomic secondary findings. We begin by showing how the duty to disclose individual research findings can be grounded in the duty of easy rescue. Next, we describe a parallel moral duty, also grounded in the duty of easy rescue, to actively hunt for such information. We then consider six possible objections to our argument, each of which we find unsuccessful. Some of these objections provide reason to limit the scope of the duty to look for secondary findings, but none provide reason to reject this duty outright. We argue that under a certain range of circumstances, researchers are morally required to hunt for these kinds of secondary findings. Although these circumstances may not currently obtain, genomic researchers will likely acquire an obligation to hunt for secondary findings as the field of genomics continues to evolve.

The precautionary principle aims to influence decision‐making in contexts where some activity poses uncertain but potentially grave threats. This perfectly describes the controversy surrounding germline gene editing. This article considers whether the precautionary principle should influence how we weigh the risks and benefits of human germline interventions, focusing especially on the possible threats to the health of future generations. We distinguish between several existing forms of the precautionary principle, assess their plausibility and consider their implications for the ethics of germline modification. We also offer a novel form of the precautionary principle: the sufficientarian precautionary principle. Some plausible versions of the precautionary principle recommend placing somewhat greater weight on avoiding threats to future generations than on achieving short‐term benefits. However, no plausible versions of the precautionary principle entail that we should outright reject the use germline gene editing in human reproduction and some, such as the sufficientarian version, might endorse its use.

Medical predictions, for example, concerning a patient's likelihood of survival, can be used to efficiently allocate scarce resources. Predictions of patient behaviour can also be used—for example, patients on the liver transplant waiting list could receive lower priority based on a high likelihood of non‐adherence to their immunosuppressant medication regimen or of drinking excessively. But is this ethically acceptable? In this paper, we will explore arguments for and against behavioural predictions, before providing novel empirical evidence on this question. Firstly, we note that including behavioural predictions would lead to improved transplant outcomes. Fairness could also require prioritising those predicted to engage in healthier behaviours: consistent with using behavioural predictions in other contexts such as psychiatry and substance misuse. Conversely, behavioural predictions may be judged too inaccurate or discriminatory, or it may be thought unfair to deprioritise based on future behaviour. In part two, we performed an online survey of 172 UK adults. When presented with possible factors relevant to liver allocation, most thought predictions of higher medication adherence (78.6%) and lower future alcohol use (76.5%) should be used but not predictions of lower future criminality (24.7%) and higher societal contribution (21.2%). Randomising participants into two groups, 69.8% of participants found deprioritising a patient based on their predicted medication adherence acceptable (91.9% found a nonbehavioural prediction acceptable). We did not identify an ethically relevant difference between behavioural predictions and other medical predictions already used in organ allocation. Our sample of participants also appeared to support behavioural predictions in this context.

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.

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.

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.

Brain organoid research raises ethical challenges not seen in other forms of stem cell research. Given that brain organoids partially recapitulate the development of the human brain, it is plausible that brain organoids could one day attain consciousness and perhaps even higher cognitive abilities. Brain organoid research therefore raises difficult questions about these organoids' moral status – questions that currently fall outside the scope of existing regulations and guidelines. This paper shows how these gaps can be addressed. We outline a moral framework for brain organoid research that can address the relevant ethical concerns without unduly impeding this important area of research.

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.

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.

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.

This chapter considers the prospect of generating human organs within chimeric animals comprised of a mix of human and animal cells. Although seemingly farfetched – the term ‘chimera’ even means, in some modern usage, a “mere wild fancy” or “unfounded conception” (Oxford English Dictionary (n.d.) ‘chimera | chimaera, n.’, OED Online. Oxford University Press. Available at: https://www.oed.com/view/Entry/31708) – recent research into interspecies blastocyst complementation is paving the way toward growing human organs inside of human-animal chimeras, potentially within the not-too-distant future Zheng et al. (Development 148(12), 2021). These human-animal chimeras promise important advances within regenerative medicine and medical research. They also raise some profound bioethical issues, which we survey below.

An innovative program recently initiated at the University of California, Los Angeles Medical Center allows people to donate a kidney in exchange for a voucher that a loved one can redeem for a kidney if and when needed. As a relatively new practice, the ethical implications of advanced kidney donation have not yet been widely discussed. This paper reflects on some of the bioethical issues at stake in this new donation program, as well as some broader philosophical issues related to the meaning and moral salience of commodification. I first consider whether the literature on commercial markets in organs––a longstanding topic of bioethical debate––can meaningfully inform ethical analysis of kidney voucher programs. Specifically, I consider whether and to what extent common objections to the exchange of kidneys for cash also apply to the exchange of kidneys for “kidney vouchers.” Second, I argue that the contrast between the ethical issues raised by these two practices highlights the need to understand commodification as existing on a continuum, with different degrees of commodification giving rise to different ethical issues. Doing so can help sharpen our understanding of commodification as a moral concept, as well as its relevance to broader debates about the moral limits of markets.

Luke Semrau argues that the documented harms of existing organ markets do not undermine the case for establishing regulated systems of paid kidney donation. He offers two arguments in support of this conclusion. First, Semrau argues that the harms of kidney selling are straightforwardly amenable to regulatory solution. Second, Semrau argues that even in existing black markets, sellers would likely have experienced greater harm if the option of selling a kidney were not available. This commentary challenges both of Semrau’s claims. I argue that there is no reason to believe that kidney sellers benefit from the current black market trade in organs, and highlight a number of potential issues regarding the effectiveness and feasibility of Semrau’s proposed market regulations.

A common strategy in bioethics is to posit a prima facie case in favour of one policy, and to then claim that the burden of proof falls on those with opposing views. If the burden of proof is not met, it is claimed, then the policy in question should be accepted. This article illustrates, and critically evaluates, examples of this strategy in debates about the sale of organs by living donors, human enhancement, and the precautionary principle. We highlight general problems with this style of argument, and particular problems with its use in specific cases. We conclude that the burden ultimately falls on decision-makers to choose the policy supported by the best reasons

In The Gift Relationship, Richard Titmuss argued that the practice of altruistic blood donation fosters social solidarity while markets in blood erode it. This paper considers the implications of this line of argument for the organ market debate. I defend Titmuss’ arguments against a number of criticisms and respond to claims that Titmuss’ work is not relevant to the context of live donor organ transplantation. I conclude that Titmuss’ arguments are more resilient than many advocates of organ markets suggest, and more relevant to the debate than is commonly appreciated.

Kidney for Sale by Owner discusses a range of different arguments that can be offered in defence of live donor kidney markets. Although Cherry’s case for establishing such markets does not rest on consequentialist considerations, Cherry nonetheless suggests that allowing the sale of organs would have net positive consequences. He argues that both renal failure patients and people living in poverty could benefit from participating in the market, and further claims that a legal trade in organs would not shape society in harmful ways. This paper argues that the likely consequences of establishing an open market in kidneys are less benign than Cherry suggests. Specifically, I argue that a live donor kidney market could plausibly harm sellers, give rise to harmful pressures to participate in the market, and reinforce unjust political and social structures. I conclude by considering the implications of these arguments for the organ market debate.

AI researchers have developed sophisticated language models capable of generating paragraphs of 'synthetic text' on topics specified by the user. While AI text generation has legitimate benefits, it could also be misused, potentially to grave effect. For example, AI text generators could be used to automate the production of convincing fake news, or to inundate social media platforms with machine-generated disinformation. This paper argues that AI text generators should be conceptualised as a dual-use technology, outlines some relevant lessons from earlier debates on dual-use life sciences research, and calls for closer collaboration between ethicists and the machine learning community to address AI language models’ dual-use implications.

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.

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.

Elizabeth Chloe Romanis argues that surrogacy, uterine transplantation (UTx) and ectogestation belong to a genus of ‘assisted gestative technologies” (“AGTs”).1 These technologies are conceptually distinct from assisted reproductive technologies (ARTs) in that they support gestation rather than conception. Romanis argues that they also raise some overlapping ethical and policy issues that are best appreciated by ‘considering these technologies together’, thus placing the issues that AGT’s share at the forefront of ethical analysis. The neologism ‘AGTs’ picks out a distinctive and important category of technologies, and there is value in considering the ethical parallels between various AGT’s. However, the category of AGTs should provide neither the only nor the main level of ethical analysis. Surrogacy, UTx and ectogestation share important parallels not only with each other but also with other practices; indeed, some of these parallels are stronger than those AGT’s share with each other. Consider ectogestation. One striking implication of ‘artificial placentas’ is that they may make it possible to terminate a pregnancy without causing the death of the fetus. This is noteworthy in part because it threatens to disrupt one influential defence of abortion rights: that they are protected by something like a moral right to bodily integrity. Once fetuses can be transferred to artificial wombs, bodily integrity would no longer support a …

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. We consider two alternatives in particular: the bioengineering of wombs using stem cells and ectogenesis. 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.

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.

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.