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Reimagining Assent: When Things Get Lost in Translation in International Pediatric Research 重新想象同意:在国际儿科研究中,当事情在翻译中迷失
IF 1.3 Q3 ETHICS Pub Date : 2025-02-28 DOI: 10.1007/s41649-024-00342-0
Sarosh Saleem

The necessity of obtaining pediatric assent for research participation is well established within international ethical guidelines. However, the effective implementation of these guidelines poses significant challenges for research ethics committees in numerous developing countries, such as Pakistan, characterized by diverse cultural and socio-economic contexts. This paper critically examines the moral underpinnings of assent, rooted in the principle of respect for persons, which aims to empower, engage, and educate children involved in research processes. Through a case example, this paper reveals the unique obstacles faced by researchers and clinicians in Pakistan, which stem from socio-cultural norms and economic disparities. Such challenges endanger the ethical foundation of assent, creating a disconnect between its philosophical basis and practical execution. Although international guidelines permit contextual adaptation of assent procedures, such flexibility is not adequately articulated within the guidelines, nor is it typically prioritized in practice. This gap undermines the purpose of assent and inadvertently increases the risk of harm to child participants—not from the research itself but rather from a process designed to protect and empower them. This paper emphasizes greater awareness among stakeholders regarding these challenges, urging a reimagined assent process in diverse global contexts. By introducing a clear rationale within research guidelines, the intent is to ensure that researchers and Institutional Review Boards (IRBs) prioritize the contextual understanding of assent, transforming it from a mere procedural formality into a meaningful practice that mitigates potential risks to children and adolescents involved in research.

获得儿童同意参与研究的必要性在国际伦理准则中得到了很好的确立。然而,这些指导方针的有效实施给许多发展中国家的研究伦理委员会带来了重大挑战,例如巴基斯坦,这些国家具有不同的文化和社会经济背景。本文批判性地考察了“同意”的道德基础,它植根于尊重人的原则,其目的是赋予参与研究过程的儿童权力、参与和教育儿童。通过一个案例,本文揭示了巴基斯坦研究人员和临床医生面临的独特障碍,这些障碍源于社会文化规范和经济差异。这些挑战危及了同意的伦理基础,在其哲学基础和实际执行之间造成了脱节。虽然国际准则允许根据具体情况调整同意程序,但这种灵活性在准则中没有充分阐明,在实践中也通常没有列为优先事项。这种差距破坏了同意的目的,并无意中增加了对儿童参与者的伤害风险——不是来自研究本身,而是来自旨在保护和授权他们的过程。本文强调了利益相关者对这些挑战的更大认识,敦促在不同的全球背景下重新构想同意过程。通过在研究指南中引入明确的基本原理,目的是确保研究人员和机构审查委员会(irb)优先考虑对同意的上下文理解,将其从纯粹的程序形式转变为有意义的实践,以减轻参与研究的儿童和青少年的潜在风险。
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引用次数: 0
Hoping Against Hope: Ethical Considerations when Trying Unproven Treatments for Seriously Ill Children 希望与希望:为重病儿童尝试未经证实的治疗时的伦理考虑
IF 1.3 Q3 ETHICS Pub Date : 2025-02-27 DOI: 10.1007/s41649-024-00340-2
Ji Hyun Yang, Yumi Son, Ilhak Lee

Modern medicine is continually evolving, yet developing and validating new treatments for paediatric patients presents significant challenges. Ethical dilemmas often arise when parents consider nonstandard treatments for their children, driven by desperation and the hope of finding effective interventions. Therefore, there is an urgent need for robust ethical frameworks to guide thier decision-making processes. Such frameworks must include the necessity for informed consent, ensuring that parents understand the potential risks and benefits of unproven treatments. Additionally, clear and open communication between parents and healthcare providers throughout the treatment journey is crucial. This ensures that decisions are made in the best interest of paediatric patients, considering their unique needs and vulnerabilities. By addressing the ethical considerations of trying unproven treatment for seriously ill children, healthcare professionals can better navigate these complexities, and ultimately foster a more compassionate and ethically sound healthcare environment.

现代医学在不断发展,但开发和验证儿科患者的新治疗提出了重大挑战。当父母出于绝望和寻求有效干预的希望而考虑对孩子进行非标准治疗时,往往会出现道德困境。因此,迫切需要强有力的道德框架来指导他们的决策过程。这种框架必须包括知情同意的必要性,确保家长了解未经证实的治疗方法的潜在风险和益处。此外,在整个治疗过程中,父母和医疗服务提供者之间清晰开放的沟通至关重要。这确保在考虑到儿科患者的独特需求和脆弱性的情况下,做出符合其最佳利益的决定。通过解决对重病儿童尝试未经证实的治疗方法的伦理考虑,医疗保健专业人员可以更好地驾驭这些复杂性,并最终培养一个更富有同情心和道德健全的医疗保健环境。
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引用次数: 0
Ethical Dilemmas in Newborn Infants with Hypoxic Ischemic Encephalopathy 新生儿缺氧缺血性脑病的伦理困境
IF 1.3 Q3 ETHICS Pub Date : 2025-02-26 DOI: 10.1007/s41649-024-00337-x
Vijay R. Baral, Yinru Lim, Priyantha Edison, Jerry Alan Menikoff

Ethical conundrums are common in neonatal medicine, particularly around continuing or withdrawing intensive treatment in a critically ill baby. A common scenario is a baby born with compromised oxygen delivery around the time of birth (perinatal asphyxia) leading to a condition named hypoxic ischemic encephalopathy (HIE) which can have a high probability of death or long-term neurologic disability. This article reviews the key ethical dilemmas that underpin the clinical management of babies with severe HIE. The discussions, however, could be relevant in any newborn with a life-threatening illness where withdrawal or redirection of intensive treatment is being considered.

伦理难题在新生儿医学中很常见,特别是在对危重婴儿继续或退出强化治疗时。一种常见的情况是婴儿出生时缺氧(围产期窒息)导致缺氧缺血性脑病(HIE),这可能有很高的死亡概率或长期神经功能障碍。这篇文章回顾了关键的伦理困境,支持婴儿与严重HIE临床管理。然而,这些讨论可能与任何患有危及生命的疾病的新生儿有关,这些疾病正在考虑退出或重新定向强化治疗。
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引用次数: 0
Assessing Risk in Implementing New Artificial Intelligence Triage Tools—How Much Risk is Reasonable in an Already Risky World? 评估实施新的人工智能分类工具的风险——在一个已经充满风险的世界里,多大的风险是合理的?
IF 1.3 Q3 ETHICS Pub Date : 2025-01-29 DOI: 10.1007/s41649-024-00348-8
Alexa Nord-Bronzyk, Julian Savulescu, Angela Ballantyne, Annette Braunack-Mayer, Pavitra Krishnaswamy, Tamra Lysaght, Marcus E. H. Ong, Nan Liu, Jerry Menikoff, Mayli Mertens, Michael Dunn

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.

由于急诊科(ED)的紧迫性、模糊的研究实践区别和高压环境等问题,急诊医学(EM)的风险预测面临着独特的挑战。开发人工智能(AI)风险预测工具的目的是简化分诊流程,减轻影响全球急诊科的长期问题,如过度拥挤和延误。由于与过度分类和分类不足、无法追踪的误报以及医疗保健专业人员对技术的偏见可能导致错误使用此类工具相关的潜在风险,这些工具的实施变得复杂。本文通过对一个案例研究的分析,探讨了围绕这些问题的风险,该案例研究涉及新加坡一种名为紧急风险预测评分(SERP)的机器学习分类工具。该工具用于估计急诊患者的死亡率风险。在两次成功的回顾性研究证明SERP具有很强的预测准确性后,研究人员认为实施前随机对照试验(RCT)不可行,因为该工具与临床判断相互作用,使盲法试验复杂化。这导致他们考虑其他测试SERP真实世界能力的方法,比如持续评估型研究。我们讨论了一项风险-收益分析的结果,以论证拟议的实施策略在道德上是适当的,并与以改进为重点的系统实施方法相一致,特别是学习型卫生系统框架(LHS),以确保安全性、有效性和持续学习。
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引用次数: 0
Four Key Questions to Guide Human Rights–based Social Listening during Infodemics 在信息流行病期间指导基于人权的社会倾听的四个关键问题。
IF 1.1 Q3 ETHICS Pub Date : 2024-12-26 DOI: 10.1007/s41649-024-00324-2
Lisa Forman

This 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?

本文以2019冠状病毒病为主要例子,考虑了在严重健康威胁期间利用社会倾听来应对信息流行病的基于人权的方法可能需要什么。本文在包括健康、生命、言论自由和隐私在内的人权背景下考虑了社会倾听,并概述了符合权利的信息传播社会倾听形式可能需要的内容。该论文认为,人权提供了防止非法和不道德形式的社会倾听的护栏,以及朝向更公平、道德和有效的公共卫生工具的路标。该文件首先扩展了COVID-19、信息传染病和社会倾听的人权层面。第二,考虑到限制这些权利的国际人权法原则,本报告考虑了与健康权、生命权和言论自由权有关的社会倾听的人权方面。最后,利用这个框架,本文提出了四个关键问题,以构建基于权利的社会倾听方法:我们为什么要倾听?我们如何倾听?我们听谁的,谁在听?这种倾听的结果是什么?
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引用次数: 0
How Chinese Researchers Face Ethical and Social Challenges in Human Organoid Research and Applications: a Questionnaire Study 中国研究人员如何面对人类类器官研究和应用中的伦理和社会挑战:一项问卷研究
IF 1.1 Q3 ETHICS Pub Date : 2024-12-21 DOI: 10.1007/s41649-024-00332-2
Huiyu Luo, Yingyan Yu, Gang Li, Yonghui Ma

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.

人类类器官的利用有可能显著加快生物创新的周期,但它也引发了一系列伦理和社会问题。本研究旨在评估研究人员对与人类类器官研究和应用相关的伦理和社会挑战的看法和态度。一份包含20个项目的调查问卷用于评估各个方面:4个项目评估对类器官的总体理解,13个项目涉及本体论、所有权、知情同意和其他伦理问题,其余4个项目侧重于伦理治理和监管问题。本问卷于2023年5月分发给第三届中国3D细胞培养与类器官研讨会的与会者。进行了基本的描述性统计分析和卡方检验。该工作已按照ARRIVE指南2.0进行了报告。绝大多数(超过70%)的参与者表示担心,人类类器官的研究和应用可能会引发伦理问题,如道德地位、知情同意和商业化。相比之下,一小部分人(4.5%,n = 8)报告对人-动物神经嵌合体感到厌恶或恶心,性别差异显著(p = 0.004)。关于人类类器官样本的知情同意,超过90%的研究人员拒绝了所有目的的全面同意,超过一半的研究人员更喜欢持续同意的模式,这需要对新用途重新征求同意。此外,超过40%的参与者认为,人类类器官的商业化取决于它们的具体类型。我们的研究结果表明,一些研究人员认为,只要人类胚胎干细胞不用于人类类器官的研究和应用,就不存在伦理问题。大多数研究者对动物的道德地位和人性化的关注也表现出漠不关心。大多数人认为“同意治理”模式比广泛同意或特定同意更可取。我们认为,要实现人类类器官的医学前景,需要应对复杂的伦理紧张局势,并积极参与不同的利益相关者。只有谨慎、周到、有效的指导,才能培养科学家与公众之间的相互理解和信任;有前途的类器官领域可以迅速和负责任地发展。
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引用次数: 0
New Beginnings for the Asian Bioethics Review 亚洲生物伦理学评论的新开端。
IF 1.3 Q3 ETHICS Pub Date : 2024-12-14 DOI: 10.1007/s41649-024-00349-7
Graeme T. Laurie
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引用次数: 0
Journeying with the Dying—Lessons from Palliative Care Physicians 与死亡同行——姑息治疗医师的经验教训。
IF 1.1 Q3 ETHICS Pub Date : 2024-12-14 DOI: 10.1007/s41649-024-00321-5
Lalit Kumar Radha Krishna, Nur Amira Binte Abdul Hamid, Nicole-Ann Lim, Chong Yao Ho, Halah Ibrahim

Witnessing 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.

在姑息治疗中目睹痛苦和死亡可能导致道德上的困扰、情感上的疲惫和适应不良的应对策略。从这些经历中产生的意义和意义如何影响医生作为专业人士的思考、感受和行为(职业认同形成或PIF)。它还决定了他们如何处理自己的角色,照顾病人以及与其他专业人士的互动。及时、个性化和适当的支持是塑造这些医生如何发展和应对有时相互竞争的信念和角色的关键。人格环理论(RToP)和Krishna-Pisupati模型(KPM)提供了一种映射人格环的方法,从而塑造、应对和创造意义。本研究使用RToP和KPM来探讨临终关怀患者对姑息治疗医师人格的影响。研究人员对一家癌症专科中心的13名姑息治疗医生进行了半结构化访谈,其中11名女性和2名男性,年龄在35岁至50岁之间。对录音访谈的文字记录进行了内容和主题分析,其中确定的互补主题和类别结合起来形成强调医生提供临终关怀的关键经验的领域。确定的领域是(1)身份形成,(2)冲突,(3)KPM要素和(4)支持系统。总之,研究结果表明,姑息治疗医生受到先天、个人、关系和社会信仰体系的驱动,这些信仰体系创造了一种交织在一起的职业和个人身份,使他们能够在自己的经历中找到意义,并在文化规范和专业期望下适应当前的环境。然而,在不断变化的个人、存在和临床因素的阻碍下,他们未能认识到自己的支持需求,这突显了持续监测的紧迫性,以及基于rtop的工具和组合系统的潜在作用,该系统可以发现并向有需要的医生提供及时、适当的支持。补充信息:在线版本包含补充资料,可在10.1007/s41649-024-00321-5获得。
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引用次数: 0
Response to Nakamura et al. 对Nakamura等人的回应。
IF 1.3 Q3 ETHICS Pub Date : 2024-12-10 DOI: 10.1007/s41649-024-00343-z
Kathryn Muyskens, Yonghui Ma, Jerry Menikoff, James Hallinan, Julian Savulescu
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引用次数: 0
Navigating Artificial Intelligence in Malaysian Healthcare: Research Developments, Ethical Dilemmas, and Governance Strategies 在马来西亚医疗保健中导航人工智能:研究发展,道德困境和治理策略。
IF 1.1 Q3 ETHICS Pub Date : 2024-12-10 DOI: 10.1007/s41649-024-00314-4
Kean Chang Phang, Tze Chang Ng, Sharon Kaur Gurmukh Singh, Teck Chuan Voo, Wellester Anak Alvis

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.

在不断发展的医疗保健人工智能(AIH)领域,了解管理其研发的实体和法律框架至关重要。本报告深入研究了马来西亚AIH的复杂性,对科学数据库、政府门户网站和新闻来源进行了全面的文献检索。此外,文献计量分析已同时进行,以辨别趋势和发展AIH多年来。值得注意的是,自2017年以来,对AIH的兴趣一直在持续上升,本地和外国创新者和应用程序开发的用例越来越多(这里报告了25个)。尽管研究和应用激增,但马来西亚缺乏专门针对AIH技术的直接立法,使其受制于11项现有法律。地方监管和伦理机构缺乏有效评估AIH研究和部署的专门知识,使这种缺乏明确监督的情况更加严重。由此产生的挑战包括人工智能创新者和应用程序面临的官僚障碍,引发了与患者自主权、隐私、数据管理、人工智能稳健性和责任相关的伦理问题。为了解决这些问题,本文建议:(1)采用AIH的国际伦理准则,(2)加强公众对AI技术的认识和教育,以及(3)通过临床或沉默试验促进AIH研究,以改善监督和促进创新。
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引用次数: 0
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Asian Bioethics Review
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