Abstract Risk prediction in emergency medicine (EM) holds unique challenges due to issues surrounding urgency, blurry research-practise distinctions, and the high-pressure environment in emergency departments (ED). Artificial intelligence (AI) risk prediction tools have been developed with the aim of streamlining triaging processes and mitigating perennial issues affecting EDs globally, such as overcrowding and delays. The implementation of these tools is complicated by the potential risks associated with over-triage and under-triage, untraceable false positives, as well as the potential for the biases of healthcare professionals toward technology leading to the incorrect usage of such tools. This paper explores risk surrounding these issues in an analysis of a case study involving a machine learning triage tool called the Score for Emergency Risk Prediction (SERP) in Singapore. This tool is used for estimating mortality risk in presentation at the ED. After two successful retrospective studies demonstrating SERP’s strong predictive accuracy, researchers decided that the pre-implementation randomised controlled trial (RCT) would not be feasible due to how the tool interacts with clinical judgement, complicating the blinded arm of the trial. This led them to consider other methods of testing SERP’s real-world capabilities, such as ongoing-evaluation type studies. We discuss the outcomes of a risk–benefit analysis to argue that the proposed implementation strategy is ethically appropriate and aligns with improvement-focused and systemic approaches to implementation, especially the learning health systems framework (LHS) to ensure safety, efficacy, and ongoing learning.

AbstractThis paper considers what a human rights–based approach to the use of social listening to counter infodemics during a serious health threat might entail, using COVID-19 as a primary example. The paper considers social listening in the context of human rights including health, life, free speech, and privacy, and outlines what a rights-compliant form of social listening to infodemics might entail. The paper argues that human rights offer guardrails against illicit and unethical forms of social listening as well as signposts towards a more equitable, ethical, and effective public health tool. The paper first expands on the human rights dimensions of COVID-19, infodemics, and social listening. Second, it considers the human rights dimensions of social listening in relation to rights to health, life, and free speech, given international human rights law principles for limiting these rights. Finally, using this framework, the paper poses four key questions to frame a rights-based approach to social listening: Why do we listen? How do we listen? Who do we listen to and who is doing the listening? And what are the outcomes of such listening?

The utilisation of human organoids has the potential to expedite the cycle of biological innovation significantly, yet it also raises a series of ethical and societal concerns. This study aims to evaluate the perceptions and attitudes of researchers regarding the ethical and social challenges associated with the research and application of human organoids. A 20-item questionnaire was developed to assess various aspects: four items evaluated the overall understanding of organoids, 13 items addressed ontological, ownership, informed consent and additional ethical issues, while the remaining four items focused on ethical governance and regulatory concerns. This questionnaire was distributed to attendees of the 3rd China Symposium on 3D Cell Culture and Organoids in May 2023. Basic descriptive statistical analyses and chi-square tests were conducted. The work has been reported in line with the ARRIVE guidelines 2.0. A substantial majority (over 70%) of participants expressed concerns that the research and application of human organoids might raise ethical issues, such as moral status, informed consent and commercialisation. In contrast, a minor segment (4.5%, n = 8) reported feelings of disgust or nausea towards human-animal neural chimeras, with a significant gender difference (p = 0.004). Regarding informed consent for human organoid samples, over 90% of researchers rejected blanket consent for all purposes, and more than half preferred a model of continuous consent, which entails resoliciting consent for new uses. Further, over 40% of participants believed that the commercialisation of human organoids is dependent on their specific type. Our findings show that some researchers held that as long as human embryonic stem cells are not utilised in human organoid research and application, there are no ethical relevant issues. Most researchers also showed indifference towards the concern of moral status and humanisation of animals. The majority believe that the “consent for governance” model is preferable than broad consent or specific consent. We believe to realise the promise of human organoids for medicine, navigating complex ethics tensions and proactively engaging diverse stakeholders are required. Only with prudent, thoughtful and effective guidance, mutual understanding and trust between scientists and public can be fostered; the promising field of organoids can progress rapidly and responsibly.

AbstractWitnessing suffering and death in palliative care can cause moral distress, emotional exhaustion and maladaptive coping strategies. How sense and meaning is made from these experiences influences how physicians think, feel and act as professionals (professional identity formation or PIF). It also determines how they cope with their roles, care for patients and interact with other professionals. Timely, personalised and appropriate support is key as shaping how these physicians develop and contend with sometimes competing beliefs and roles. The Ring Theory of Personhood (RToP) and the Krishna-Pisupati Model (KPM) offer a means of mapping PIF and thus moulding, coping and meaning making. This study uses the RToP and KPM to explore how caring for end-of-life patients impacts the personhood of palliative care physicians. Semi-structured interviews with a purposive sample of 13 palliative care physicians—eleven females and two males aged between 35 and 50 years—at a cancer specialist centre were conducted. Transcripts of the audio-recorded interviews underwent content and thematic analysis where complementary themes and categories identified were combined to form domains that highlighted the physicians’ key experience of providing end-of-life care. The domains identified were (1) identity formation, (2) conflicts, (3) KPM elements and (4) support systems. Together, results revealed that palliative care physicians are driven by Innate, Individual, Relational and Societal belief systems that create an intertwined professional and personal identity, enabling them to find meaning in their experiences and adapt to present contexts within cultural norms and professional expectations. However, their failure to recognise their need for support when hampered by evolving personal, existential and clinical factors underlines the exigency for ongoing surveillance and a potential role for a RToP-based tool and portfolio system that can detect and direct timely, appropriate support to in-need physicians.

In the ever-evolving landscape of Artificial Intelligence in Healthcare (AIH), understanding the entities and legal frameworks governing its research and development is crucial. This report delves into the intricacies of AIH in Malaysia, undertaking a comprehensive literature search on scientific databases, government portals, and news sources. Additionally, bibliometric analysis has been concurrently conducted to discern trends and developments in AIH over the years. Notably, the interest in AIH has seen a consistent rise since 2017, marked by a growing number of use cases (25 reported here) developed by both local and foreign innovators and applicators. Despite this surge in research and adoption, Malaysia lacks direct legislation specifically addressing AIH technologies, leaving them subject to 11 existing laws. This lack of clear oversight is compounded by the insufficient expertise within local regulatory and ethical bodies to effectively assess AIH research and deployment. The resultant challenges include bureaucratic hurdles for AIH innovators and applicators, raising ethical concerns related to patient autonomy, privacy, data management, AI robustness, and liability. To address these issues, this paper recommends: (1) adopting international ethical guidelines for AIH, (2) enhancing public awareness and education on AI technologies, and (3) promoting AIH research through clinical or silent trials to improve oversight and foster innovation.

Given ICH-GCP’s role in shaping IRB standards in most jurisdictions, clarifying the function and definition of nonscientific members is crucial. ICH-GCP 3.2.1 requires a nonscientific member but its definition focuses on who they are not rather than who they are, creating ambiguity and varied interpretations. This paper reviews the idea of nonscientific members of the IRB to understand their definitions and roles based on current literature. This is because, despite the ICH-GCP’s mandate, recent research is scarce. Our review identifies that in the current literature, various definitions and roles are ascribed to nonscientific members, resulting in a lack of clarity. Following our thematic analysis, we highlight two main interpretations of the nonscientific member’s definition: one as a distinct perspective from scientific members and another as an embodiment of “ordinariness” to minimize bias. In addition, we also highlight three primary roles: reviewing consent forms, representing public and participant interests, and providing oversight. Some findings may not align with current IRB practices, and without clear definitions, adherence to ICH-GCP guidelines may be inconsistent.

The utilization of in-vitro fertilization (IVF) in assisted reproduction has undergone a notable surge since its inception in 1979. Consequently, the demand for well-trained IVF personnel has become crucial to address the expanding technical requirements of this field. However, acquiring specialized technical expertise remains a challenge in various regions and countries, particularly in the Arab Islamic region, frequently playing a pivotal role in the successful implementation of medical technology. Ensuring a proficient workforce of IVF experts requires the provision of practical and comprehensive training opportunities. This work reveals the ethical considerations surrounding the utilization of actual human eggs in IVF training courses and examines potential alternative approaches to meet the training needs in a manner deemed ethically acceptable. We analyzed the bioethical issues of using human eggs in IVF training, considering ethical principles, benefits, and concerns to determine permissibility and contribute to discussions on reproductive technology ethics and the responsible use of human reproductive material. In addition, we shed light on perspectives from Islamic scholarship. In conclusion, utilizing immature eggs in practical IVF training, while ensuring informed consent, is widely deemed acceptable within the ethical framework. However, the crucial necessity of robust oversight, especially in the private sector, cannot be overstated. To address these critical considerations, the initial and fundamental step entails conducting a comprehensive regional survey. Using immature eggs in IVF training seems acceptable, but it is crucial to establish an oversight practice. Organizing a collaborative workshop with stakeholders from both the public and private sectors is a crucial first step in developing this controlled practice.

Abstract A significant and important ethical tension in resource allocation and public health ethics is between utility and equity. We explore this tension between utility and equity in the context of health AI through an examination of a diagnostic AI screening tool for diabetic retinopathy developed by a team of researchers at Duke-NUS in Singapore. While this tool was found to be effective, it was not equally effective across every ethnic group in Singapore, being less effective for the minority Malay population than for the Chinese majority. We discuss the problematic normative nature of bias in health AI and explore the ways in which bias can interact with various forms of social inequalities. From there, we examine the specifics of the diabetic retinopathy case and weigh up specific trade-offs between utility and equity. Ultimately, we conclude that it is ethically permissible to prioritise utility over equity where certain criteria hold. Given that any medical AI is more likely than not to have lingering bias due to bias in the training data that may reflect other social inequalities, we argue that it is permissible to implement an AI tool with residual bias where: (1) its introduction reduces the influence of biases (even if overall inequality is worsened), and/or (2) where the utility gained is significant enough and shared across groups (even if unevenly).

Abstract Deception in research is contentious, as ethical codes stress informed consent, yet complete disclosure may jeopardise validity. Indian Council for Medical Research (ICMR) guidelines classify deception into active, incomplete, and authorised forms. This study explores the ethical justification for incomplete (partial disclosure), permissible instances, and the dilemma faced by ethics committees in balancing scientific rigour and participant protection. The qualitative, non-experimental cross-sectional research, using in-depth interviews, identifies themes through thematic analysis. Findings reveal challenges for ethics committees, as incomplete information hampers understanding, amongst others. The paper proposes an ethics committee framework, urging researchers to minimise or avoid partial deception and recommending institutional awareness campaigns and standard operating procedures for minimal-harm studies using partial disclosure. Therefore, it proposes that partial disclosure should be justified by the 3Vs—value, validity, and veracity to preserve research integrity.

Abstract Japan has been reported as a country with high levels of vaccine hesitancy. However, a lack of comprehensive reviews studying factors for vaccine hesitancy for the COVID-19 vaccines in the Japanese context from the perspective of ethical controversy exists. Using a narrative review method, we reviewed factors associated with vaccine hesitancy to the COVID-19 vaccines and examined issues related to ethical controversy among the Japanese population. Factors associated with vaccine hesitancy include concerns about vaccine safety, suspicion of vaccine inefficacy, mistrust of the government, and low perceived threat. Factors associated with vaccine acceptance include environmental factors, factors related to Japanese cultural values, including collectivism and social norms, and positive attitudes toward information provided by authorities. Unique backgrounds in Japan are historical events such as the anti-HPV vaccine campaigns, the accessible medical system fostering high expectations of zero risk, and cultural factors of caring social norms influencing vaccine acceptance. Ethical controversies arise from preferences and practices at the individual or national level around individual rights versus public health benefits. Healthcare professionals and public health experts should continue dialoguing with the critical mass, practitioners, and policymakers, considering the ethical dilemmas surrounding individual rights and public health benefits. Insights obtained from this study indicate the need to develop tailored strategies to enhance vaccine acceptance while respecting individual autonomy within the Japanese context.

Hospitalized patients lacking the mental capacity to consent to treatment may demand to be discharged from the hospital against medical advice. Forced custody of these patients, including the use of restraints, may be required if the plan is to proceed with treatment. This raises ethical concerns with regard to depriving people of their liberty. The determination of the wishes and values of the patient and her best interests may sometimes vary, depending on the assessor or the clinical team entrusted to perform the evaluation. We therefore propose the following triad for clinicians when determining the best interests for this group of patients to ensure ethical and legal soundness as well as in providing consistency in approach. Firstly, the treatment should serve as a rescue response. Secondly, any restraint deployed must be proportionate with a foreseeable end. Her liberty and autonomy interests should be enhanced by the treatment. Thirdly, the patient’s family must be supportive. This paper analyzes the use of the triad approach on two clinical cases, both assessed as lacking in mental capacity to decide on treatment and insisting to be discharged. Using this approach, we could justify how the contrasting outcomes, one in which the voluntary discharge was acquiesced versus the other, which was not acquiesced, were reached. We also examine the compatibility of the triad approach with the obligations under the United Nations Convention on the Rights of Persons with Disabilities (UNCRPD).

The dilemmas and uncertainties related to determining mental capacity and surrogate decision-making are universally recognised as one of the most important concepts in the field of clinical ethics. In Malaysia, healthcare practitioners often find both determining decision-making capacity of patients, and identifying surrogate decision makers for incapacitated patients confusing. This paper explores the concepts of decision-making capacity and surrogate decision-making, identifying key components and associated principles such as substituted judgement and best interests. It reviews current provisions and guidances available in Malaysia that are related to these issues, including the Power of Attorney Act 1949 (revised 1990), Mental Health Act 2001, and various guidelines. It then highlights the challenges encountered in the local clinical setting due to the lack of specific legislation and clear guidance. Finally, this paper provides recommendations for improvements to address these issues in order to safeguard both the clinical practice of healthcare professionals and the rights of patients. These recommendations include the establishment of a regulatory framework with four main domains: clear and objective criteria for mental capacity assessment, provisions for advance decision-making while patients still possess mental capacity, a ladder or hierarchy of surrogate decision-makers, and provisions for appropriate surrogate decision-making standards, as well as the need for advocacy and awareness education among both the general public and healthcare professionals.

Clinical ethics consultations (CECs) play an important role in resolving ethical issues in clinical practice worldwide. The government has encouraged the development of CECs in China to address the ethical challenges arising in prenatal diagnosis. So far, the current state and challenges facing CEC remain understudied. This study aimed to explore the perspectives of employees on ethics committees for prenatal diagnosis in 13 medical institutions in Hunan Province, China. Twenty-eight employees participated in interviews. Our qualitative approach employed content analysis to identify major themes in interviewees’ responses, which covered the composition and vision of their prenatal diagnosis ethics committee, as well as the challenges they faced. The results show that CEC in China is in an exploratory stage, with models for CEC composition, and workflow varying significantly. Therefore, we propose the future direction of efforts to improve CECs, including improving CEC working mechanisms and operating procedures, strengthening ethical training for healthcare workers and ethics committee employees, and developing more specific ethical guidance based on the accumulated experiences of ethics committee employees in the early development of CEC for prenatal diagnosis.

Assisted reproductive technologies (ARTs) have become a widely utilized medical technology for treating infertility worldwide. However, societies and countries have applied these technologies in accordance with their cultural practices and belief systems. This paper presents an overview of ART providers in Bangladesh and analyzes their online content in addressing potential infertile couples. Examining the topic within the context of socio-economic and public health challenges in Bangladesh, particularly overpopulation, poverty, and lack of education, the research conducted a web content analysis of ART providers in Bangladesh from July 1 to September 1, 2023. Twenty active ART providers were identified using Google searches and an exploratory key. The analysis considered locations, landing page information, ethical standards, quality certification, foreign affiliations, and success rates. The findings revealed a concentration of centers in urban areas, raising concerns about equitable access. The absence of regulation and guidelines, coupled with the lack of ART clinic registration, highlighted potential risks to patient well-being. Landing page statements utilized highly emotive language and ambiguous terms, raising ethical concerns. The absence of explicit mention of quality standards, including ISO 9001:2000 certification, indicated potential gaps in transparency. Foreign affiliations were employed for credibility, raising concerns of misleading advertising. Limited and ambiguous reporting of success rates posed challenges for informed decision-making. Evident exploitative and commercialized practices raised concerns about potentially commodifying reproductive services. The study emphasizes the need for regulatory frameworks, transparency in reporting, adherence to ethical advertising, and increased cultural sensitivity to enhance the ethical standards of ART providers in Bangladesh.