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Environmental risk and market approval for human pharmaceuticals. 人类药品的环境风险和市场审批。
IF 1.6 Q2 ETHICS Pub Date : 2024-07-03 DOI: 10.1007/s40592-024-00195-1
Davide Fumagalli

This paper contributes to the growing discussion about how to mitigate pharmaceutical pollution, which is a threat to human, animal, and environmental health as well as a potential driver of antimicrobial resistance. It identifies market approval of pharmaceuticals as one of the most powerful ways to shape producer behavior and highlights that applying this tool raises ethical issues given that it might impact patients' access to medicines. The paper identifies seven different policy options that progressively give environmental considerations increased priority in the approval process, identifies ethically relevant interests affected by such policies, and makes explicit tensions and necessary tradeoffs between these interests. While arguing that the current European regulation gives insufficient weight to environmental considerations, the paper highlights concerns with the strongest policy options, on the grounds that these may very well endanger patients' access to effective medication.

制药污染是对人类、动物和环境健康的威胁,也是抗菌药耐药性的潜在驱动因素。本文指出,药品的市场审批是影响生产者行为的最有力方法之一,并强调应用这一工具会引发道德问题,因为它可能会影响患者获得药品。本文提出了七种不同的政策选择,在审批过程中逐步提高环境因素的优先级,确定了受这些政策影响的伦理相关利益,并明确指出了这些利益之间的紧张关系和必要的权衡。本文认为现行的欧洲法规对环境因素的重视程度不够,同时强调了对最强有力的政策方案的担忧,理由是这些方案很可能会危及患者获得有效药物的机会。
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引用次数: 0
COVID-19 vaccines: history of the pandemic's great scientific success and flawed policy implementation. COVID-19 疫苗:大流行病的巨大科学成功与政策实施缺陷的历史。
IF 1.6 Q2 ETHICS Pub Date : 2024-06-01 Epub Date: 2024-03-09 DOI: 10.1007/s40592-024-00189-z
Vinay Prasad, Alyson Haslam

The COVID-19 vaccine has been a miraculous, life-saving advance, offering staggering efficacy in adults, and was developed with astonishing speed. The time from sequencing the virus to authorizing the first COVID-19 vaccine was so brisk even the optimists appear close-minded. Yet, simultaneously, United States' COVID-19 vaccination roll-out and related policies have contained missed opportunities, errors, run counter to evidence-based medicine, and revealed limitations in the judgment of public policymakers. Misplaced utilization, contradictory messaging, and poor deployment in those who would benefit most-the elderly and high-risk-alongside unrealistic messaging, exaggeration, and coercion in those who benefit least-young, healthy Americans-is at the heart. It is important to consider the history of COVID-19 vaccines to identify where we succeeded and where we failed, and the effects that these errors may have more broadly on vaccination hesitancy and routine childhood immunization programs in the decades to come.

COVID-19 疫苗是一项拯救生命的奇迹,它对成人的疗效惊人,而且研发速度惊人。从病毒测序到授权生产第一支 COVID-19 疫苗的时间如此之快,甚至连乐观主义者都显得心胸狭窄。然而,与此同时,美国 COVID-19 疫苗的推广和相关政策却错失良机,出现失误,与循证医学背道而驰,并暴露出公共政策制定者判断力的局限性。其核心问题是,对受益最大的人群--老年人和高危人群--使用不当、信息矛盾、部署不当,而对受益最小的人群--年轻、健康的美国人--则采取了不切实际的信息传递、夸大宣传和强制措施。回顾 COVID-19 疫苗的历史,找出我们成功的地方和失败的地方,以及这些错误在未来几十年中可能对疫苗接种犹豫不决和常规儿童免疫计划产生的更广泛的影响,这一点非常重要。
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引用次数: 0
Assisted dying in Swedish healthcare: a qualitative analysis of physicians' reasoning about physician-assisted suicide. 瑞典医疗保健中的协助死亡:对医生协助自杀推理的定性分析。
IF 1.6 Q2 ETHICS Pub Date : 2024-06-01 Epub Date: 2024-07-26 DOI: 10.1007/s40592-024-00202-5
Anna Lindblad, Niklas Juth, Ingemar Engström, Mikael Sandlund, Niels Lynøe

To explore Swedish physicians' arguments and values for and against physician-assisted suicide (PAS) extracted from the free-text comments in a postal survey. A random selection of approximately 240 physicians from each of the following specialties: general practice, geriatrics, internal medicine, oncology, surgery and psychiatry. All 123 palliative care physicians in Sweden. A qualitative content analysis of free-text comments in a postal questionnaire commissioned by the Swedish Medical Society in collaboration with the Karolinska Institute in Stockholm. The total response rate was 59.2%. Of the 933 respondents, 1107 comments were provided. The free-text comments entailed both normative and factual arguments for and against PAS. The analysis resulted in two main categories: (1) "Safe implementation of PAS is unachievable" (with subcategories "Criteria of PAS difficult to fulfil" and "PAS puts societal norms and values at risk") and (2) "The role of PAS in healthcare" (with subcategories "No medical need for PAS", "PAS is not a task for physicians", "No ethical difference to other end-of-life decisions" and "PAS is in the patient's best interest"). The respondents brought up well-known arguments from academic and public debate on the subject. Comments from physicians against PAS were more often emotionally charged and used devices like dysphemisms and slippery-slope arguments.

从一项邮寄调查的自由文本评论中提取瑞典医生支持和反对医生协助自杀(PAS)的论点和价值观。从以下各专科随机抽取约 240 名医生:全科、老年病科、内科、肿瘤科、外科和精神病科。瑞典所有 123 名姑息关怀医生。瑞典医学会与斯德哥尔摩卡罗林斯卡研究所合作,对邮寄问卷中的自由文本评论进行了定性内容分析。总回复率为 59.2%。在 933 位受访者中,有 1107 条评论。自由文本评论包括支持和反对 PAS 的规范性和事实性论据。分析结果分为两大类:(1) "无法安全实施临终关怀"(子类为 "临终关怀的标准难以实现 "和 "临终关怀使社会规范和价值观面临风险")和 (2) "临终关怀在医疗保健中的作用"(子类为 "临终关怀没有医疗需求"、"临终关怀不是医生的任务"、"与其他临终决定在伦理上没有区别 "和 "临终关怀符合患者的最佳利益")。受访者提出了学术界和公众辩论中众所周知的论点。医生反对临终关怀的评论则更多地带有情绪色彩,并使用了语病和滑坡论证等手段。
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引用次数: 0
The foundations of informed consent and bodily self-sovereignty: a positive suggestion. 知情同意和身体自我主权的基础:一个积极的建议。
IF 1.6 Q2 ETHICS Pub Date : 2024-06-01 Epub Date: 2024-08-22 DOI: 10.1007/s40592-024-00203-4
Joanna Smolenski

In medical care, the obtaining of informed consent is taken to be required prior to treatment in order to ensure that patients sufficiently understand the potential risks and benefits of a given medical procedure. In this paper, I begin by looking at the history of informed consent and consider how the norms and laws in medicine have evolved away from benevolent paternalism and toward a blanket obligation to obtain informed consent. In so doing, I consider what values might be taken to underpin such a requirement. After dismissing some unsatisfactory answers, I offer a positive view as to the constellation of values I think informed consent ought to be protecting. I call these bodily self-sovereignty, which I take to be a coupling of two groups of values: autonomy and non-domination on the one hand, and self-ownership and personal integrity on the other. Given the connection between autonomy and responsibility, autonomy is both required for the act of consenting, and respected by allowing it. And, because of our special and inescapable relationship to our own bodies, this authorization is particularly important when our bodies are involved. So, I suggest that informed consent protects our self-sovereignty over our own bodies.

在医疗保健中,为了确保患者充分了解特定医疗程序的潜在风险和益处,在治疗前必须获得知情同意。在本文中,我首先回顾了知情同意的历史,并探讨了医学规范和法律是如何从仁慈的家长式管理演变为全面的知情同意义务的。在此过程中,我还考虑了支持这一要求的价值观是什么。在否定了一些不尽人意的答案之后,我提出了一个积极的观点,即我认为知情同意应当保护的价值观。我把这些价值称为身体的自我主权,我认为它是两组价值的结合:一方面是自主权和非统治权,另一方面是自我所有权和人格完整。鉴于自主与责任之间的联系,自主既是同意行为的必要条件,也是允许同意行为的尊重条件。而且,由于我们与自己的身体有着不可分割的特殊关系,当涉及到我们的身体时,这种授权就显得尤为重要。因此,我认为知情同意保护了我们对自己身体的自我主权。
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引用次数: 0
The mutuality account of parenthood: a subjective approach to parent-child relationships. 亲子关系的相互性:亲子关系的主观方法。
IF 1.6 Q2 ETHICS Pub Date : 2024-06-01 Epub Date: 2024-07-11 DOI: 10.1007/s40592-024-00198-y
Isabella Holmes, Rosalind McDougall

Stimulated by development of reproductive technologies, many current bioethical accounts of parenthood focus on defining parenthood at or around birth. They tend to exclude from their scope some parent-child relationships that develop later in a child's life. In reality, a parent-child relationship can emerge or dissolve over time: the parents of person A as an adolescent or adult may be different to her parents when she is a young child. To address this aspect of parenthood, we propose a new 'mutuality account' of parenthood, grounded in the concept of ontological security. We argue that in most cases a parent-child relationship exists if there is mutual ontological security between the parent and child. We suggest that this mutual ontological security is constituted and sustained by shared frameworks of reality and cohesive personal narratives. Our intention is to broaden the conceptual understanding of parenthood, to include parent-child relationships that do not fall neatly into current bioethical accounts, and to argue against the notion that objective physiological, causal, or social ties are necessary to 'make' a parent.

在生殖技术发展的推动下,目前许多关于父母身份的生物伦理论述都侧重于界定出生时或出生前后的父母身份。它们往往将儿童生命后期发展起来的一些亲子关系排除在外。在现实生活中,亲子关系会随着时间的推移而出现或消解:青少年或成年人 A 的父母可能不同于她年幼时的父母。针对亲子关系的这一方面,我们提出了一种新的亲子关系 "相互性解释",其基础是本体安全概念。我们认为,在大多数情况下,如果父母与子女之间存在本体论上的相互安全感,亲子关系就会存在。我们认为,这种相互的本体论安全感是由共同的现实框架和有凝聚力的个人叙事构成和维持的。我们的目的是拓宽对亲子关系的概念性理解,将那些不完全属于当前生命伦理学范畴的亲子关系纳入其中,并反对客观的生理、因果或社会关系是 "造就 "父母的必要条件这一观点。
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引用次数: 0
Biosafety, biosecurity, and bioethics. 生物安全、生物安保和生物伦理。
IF 1.6 Q2 ETHICS Pub Date : 2024-06-01 Epub Date: 2024-07-30 DOI: 10.1007/s40592-024-00204-3
David B Resnik

The COVID-19 pandemic has highlighted the importance of biosafety in the biomedical sciences. While it is often assumed that biosafety is a purely technical matter that has little to do with philosophy or the humanities, biosafety raises important ethical issues that have not been adequately examined in the scientific or bioethics literature. This article reviews some pivotal events in the history of biosafety and biosecurity and explores three different biosafety topics that generate significant ethical concerns, i.e., risk assessment, risk management, and risk distribution. The article also discusses the role of democratic governance in the oversight of biosafety and offers some suggestions for incorporating bioethics into biosafety practice, education, and policy.

COVID-19 大流行凸显了生物医学科学中生物安全的重要性。虽然人们通常认为生物安全是一个纯粹的技术问题,与哲学或人文学科关系不大,但生物安全提出了一些重要的伦理问题,而这些问题在科学或生物伦理学文献中尚未得到充分研究。本文回顾了生物安全和生物安保历史上的一些关键事件,探讨了引发重大伦理问题的三个不同的生物安全主题,即风险评估、风险管理和风险分配。文章还讨论了民主治理在生物安全监督中的作用,并就将生物伦理纳入生物安全实践、教育和政策提出了一些建议。
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引用次数: 0
Deference or critical engagement: how should healthcare practitioners use clinical ethics guidance? 遵从还是批判性参与:医疗从业人员应如何使用临床伦理指南?
IF 1.6 Q2 ETHICS Pub Date : 2024-06-01 Epub Date: 2024-02-29 DOI: 10.1007/s40592-023-00186-8
Ben Davies, Joshua Parker

Healthcare practitioners have access to a range of ethical guidance. However, the normative role of this guidance in ethical decision-making is underexplored. This paper considers two ways that healthcare practitioners could approach ethics guidance. We first outline the idea of deference to ethics guidance, showing how an attitude of deference raises three key problems: moral value; moral understanding; and moral error. Drawing on philosophical literature, we then advocate an alternative framing of ethics guidance as a form of moral testimony by colleagues and suggest that a more promising attitude to ethics guidance is to approach it in the spirit of 'critical engagement' rather than deference.

医疗从业人员可以获得一系列伦理指导。然而,这些指导在伦理决策中的规范作用却未得到充分探讨。本文探讨了医疗从业人员对待伦理指导的两种方式。我们首先概述了服从伦理指导的观点,说明服从的态度如何引发三个关键问题:道德价值、道德理解和道德错误。然后,我们借鉴哲学文献,主张将伦理指导作为同事道德见证的一种形式,并建议以 "批判性参与 "的精神而非敬畏的态度对待伦理指导,这是一种更有前途的态度。
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引用次数: 0
COVID-19 ethics: unique aspects and a review as of early 2024. COVID-19 伦理学:独特方面和截至 2024 年初的审查。
IF 1.6 Q2 ETHICS Pub Date : 2024-06-01 Epub Date: 2024-07-13 DOI: 10.1007/s40592-024-00199-x
Wayne X Shandera

COVID-19 presents a variety of ethical challenges in a set of arenas, arenas not always considered in past pandemics. These challenges include issues related to autonomy, distributive ethics, and the establishment of policies of equity and justice. Methods are a literature review based on regular editing of an online textbook during the COVID-19 outbreak and a literature review using key ethical terms. Patients are confronted with new issues related to autonomy. Providers need to expand their concepts of ethical issues to include decisions based on proportionality and public health ethics. The public health sector needs to assess the beneficence of alternative modes of disease control. The research community needs to redefine the concept of informed consent in emergent conditions. All elements of the medical spectrum-physicians, scientists, and the community-at-large including the pharmaceutical industry-need to consider the multifaceted methods for preventing future pandemics. This will require giving particular emphasis to public health funding and ending the documented discrimination that exists in the provision of proven therapies. The developing world is especially at risk for most of the ethical issues, especially those related to equity and justice. The ethical issues associated with the COVID-19 outbreak are not unique but provide a diverse set of issues that apply to patients, providers, social groups, and investigators. The further study of such issues can help with preventing future outbreaks.

COVID-19 在一系列领域提出了各种伦理挑战,这些领域在以往的大流行病中并不总是得到考虑。这些挑战包括与自主权、分配伦理以及公平和正义政策的制定有关的问题。研究方法是在 COVID-19 爆发期间定期编辑在线教科书的基础上进行文献综述,以及使用关键伦理术语进行文献综述。患者面临着与自主权相关的新问题。医疗服务提供者需要扩展他们的伦理问题概念,将基于相称性和公共卫生伦理的决策纳入其中。公共卫生部门需要评估其他疾病控制模式的益处。研究界需要重新定义紧急情况下的知情同意概念。医学界的所有成员--医生、科学家和包括制药业在内的整个社会--都需要考虑预防未来流行病的多方面方法。这就需要特别重视公共卫生资金,结束在提供行之有效的疗法方面存在的歧视。在大多数伦理问题上,特别是与公平和正义有关的问题上,发展中国家尤其面临风险。与 COVID-19 爆发相关的伦理问题并非独一无二,但却提供了一系列适用于患者、医疗服务提供者、社会团体和研究人员的不同问题。对这些问题的进一步研究有助于预防未来的疫情爆发。
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引用次数: 0
Contact investigation in multidrug-resistant tuberculosis: ethical challenges. 耐多药结核病的接触调查:伦理挑战。
IF 1.6 Q2 ETHICS Pub Date : 2024-06-01 Epub Date: 2024-03-02 DOI: 10.1007/s40592-024-00188-0
Hnin Si Oo, Pascal Borry

Contact investigation is an evidence-based intervention of multidrug-resistant tuberculosis (MDR-TB) to protect public health by interrupting the chain of transmission. In pursuit of contact investigation, patients' MDR-TB status has to be disclosed to third parties (to the minimum necessary) for tracing the contacts. Nevertheless, disclosure to third parties often unintentionally leads the MDR-TB patients suffered from social discrimination and stigma. For this reason, patients are less inclined to reveal their MDR-TB status and becomes a significant issue in contact investigation. This issue certainly turns into a negative impact on the public interest. Tension between keeping MDR-TB status confidential and safeguarding public health arises in relation to this issue. Regarding MDR-TB management, patient compliance with treatment and contact investigation are equally important. Patients might fail to comply with anti-TB therapy and be reluctant to seek healthcare due to disclosure concerns. In order to have treatment adherence, MDRTB patients should not live through social discrimination and stigma arising from disclosure and TB team has a duty to support them as a mean of reciprocity. However, implementation of contact investigation as a public health policy can still be challenging even with promising reciprocal support to the patients because MDR-TB patients are living in different contexts and situations. There can be no straight forward settlement but an appropriate justification for each distinct context is needed to strike a balance between individual confidentiality and public interest.

接触调查是一种以证据为基础的耐多药结核病(MDR-TB)干预措施,通过阻断传播链来保护公众健康。在进行接触调查时,患者的耐多药结核病状况必须(在必要的最低限度内)向第三方披露,以便追踪接触者。然而,向第三方披露病情往往会无意中导致 MDR-TB 患者遭受社会歧视和羞辱。因此,患者不太愿意透露自己的 MDR-TB 感染情况,这成为接触者调查中的一个重要问题。这一问题无疑会对公众利益造成负面影响。在对 MDR-TB 病情保密和保护公众健康之间,出现了与此相关的矛盾。关于 MDR-TB 的管理,患者遵从治疗和接触调查同样重要。患者可能无法坚持抗结核治疗,并因担心泄露而不愿寻求医疗服务。为了保证治疗的依从性,MDRTB 患者不应因披露而遭受社会歧视和羞辱,结核病团队有责任为他们提供支持,以实现互惠互利。然而,由于 MDRTB 患者的生活环境和处境各不相同,即使承诺为患者提供互惠支持,作为公共卫生政策的接触调查的实施仍具有挑战性。没有一劳永逸的解决办法,但需要为每种不同的情况提供适当的理由,以便在个人保密和公共利益之间取得平衡。
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引用次数: 0
Justification for coercion in a public health crisis: not just a matter of individual harm. 公共卫生危机中的胁迫理由:不仅仅是个人伤害问题。
IF 1.6 Q1 Arts and Humanities Pub Date : 2024-05-18 DOI: 10.1007/s40592-024-00196-0
Lucie White

The COVID pandemic was an exceptional public health situation - which brought with it unprecedented restrictions across the global populace. But what was it about this pandemic which caused us to implement such drastic restrictions on liberty? Much of the ethical debate on restrictive measures such as lockdowns and vaccine requirements focused on the potential harm that individuals cause to other individuals by the risk of infection. I will suggest that this may come from a reliance on J.S. Mill's harm principle as providing the ultimate justification for coercion - i.e., the well-accepted principle that state coercion is justified in order to prevent the imposition of unacceptable risk of harm to others. Though there have been attempts, in the wider public health ethics literature, to use the harm principle as a basis for restricting contribution to collective harms, I will suggest that these attempts cannot rely on the harm principle alone. I will then turn to the ways in which an individual-based line of reasoning does not capture a distinctive sort of harm posed by the COVID pandemic (and others like it): the potential failure of healthcare systems. I will draw out three ways in which a focus on the harm that an individual poses to another individual fails to capture the full scope of harm wrought by the collapse of healthcare systems. First, it can't adequately capture the cumulative and "looping effects" of the harm caused by strained healthcare systems. Second, it fails to capture the widespread ripple effects the failure of a central societal institution can have on other institutions. And third, the failure of a healthcare system can impose "psychic costs", affecting the moral character of all members of society, reducing trust in institutions, and potentially posing an existential threat to the fabric of society. Finally, I will sketch some implications of the recognition of this distinctive sort of harm for the justification of coercive public health measures.

COVID 大流行是一次特殊的公共卫生事件--它给全球民众带来了前所未有的限制。但究竟是什么原因导致我们对自由实施如此严厉的限制?关于封锁和疫苗要求等限制性措施的伦理辩论大多集中在个人因感染风险而对他人造成的潜在伤害上。我认为,这可能是由于人们依赖 J.S. 密尔的伤害原则,将其作为强制的最终理由--即国家强制是为了防止对他人造成不可接受的伤害风险,这一原则已被广泛接受。尽管在更广泛的公共卫生伦理学文献中,有人试图将伤害原则作为限制集体伤害的基础,但我将指出,这些尝试不能仅仅依赖于伤害原则。然后,我将论述基于个体的推理如何无法捕捉到 COVID 大流行(以及其他类似流行)所造成的一种独特伤害:医疗保健系统的潜在失灵。我将从三个方面来说明,关注个体对他人造成的伤害并不能全面反映医疗系统崩溃所造成的伤害。首先,它无法充分捕捉到医疗系统紧张所造成的伤害的累积效应和 "循环效应"。其次,它未能反映出一个核心社会机构的失败可能对其他机构产生的广泛连锁反应。第三,医疗系统的失灵会造成 "心理成本",影响社会所有成员的道德品质,降低对机构的信任,并可能对社会结构的存在构成威胁。最后,我将简要说明认识到这种独特的伤害对强制性公共卫生措施的合理性的一些影响。
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引用次数: 0
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Monash Bioethics Review
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