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Pathogen dematerialization and the ABS loophole. 病原体非物质化和ABS漏洞。
IF 3.4 2区 哲学 Q1 ETHICS Pub Date : 2023-01-01 DOI: 10.1093/jlb/lsad002
Abbie-Rose Hampton
Law School, Oxford University Press, and Stanford Law School. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. Journal of Law and the Biosciences, 1–20 https://doi.org/10.1093/jlb/lsad002 Essay
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引用次数: 0
Why reason-based abortion bans are not a remedy against eugenics: an empirical study. 为什么基于理性的堕胎禁令不是对优生学的补救措施:一项实证研究。
IF 3.4 2区 哲学 Q1 ETHICS Pub Date : 2023-01-01 DOI: 10.1093/jlb/lsac033
Sonia M Suter

In Box v Planned Parenthood, Justice Thomas wrote an impassioned concurrence describing abortions based on sex, disability or race as a form of 'modern-day eugenics'. He defended the challenged Indiana reason-based abortion (RBA) ban as a necessary antidote to these practices. Inspired by this concurrence, legislatures have increasingly enacted similar bills and statutes allegedly as a prophylactic to 'eugenics', its underlying discrimination, and the racial disparities eugenics caused. This article tests my hypothesis that this legislative focus on eugenics is largely performative, rather than evidence of true concern about the discrimination and disparities underlying eugenics. My research examined state laws in several areas that fall within narrow and broad understandings of eugenics to determine whether states with RBA bans have implemented policies to counteract eugenics more broadly. My analysis shows that they generally have not. Instead, the apparent motivation is to commandeer concerns about eugenics to restrict reproductive rights. This legislative mission is hypocritical, and it harms the very groups impacted by the eugenics movements-minorities, women, people with disabilities, the LGBTQ+ community, and immigrants. Ultimately, it has led us to Dobbs, which makes everyone vulnerable to the eugenics policies Thomas condemns by undercutting previous constitutional protections against eugenics.

在方框诉计划生育一案中,托马斯大法官写了一篇慷慨激昂的意见书,将基于性别、残疾或种族的堕胎描述为“现代优生学”的一种形式。他为印第安纳州受到质疑的理性堕胎禁令(RBA)辩护,称这是应对这些做法的必要手段。在这种共识的启发下,立法机构越来越多地颁布了类似的法案和法规,据称是为了预防“优生学”,其潜在的歧视,以及优生学造成的种族差异。本文验证了我的假设,即立法对优生学的关注主要是表现性的,而不是对优生学背后的歧视和差异的真正关注的证据。我的研究检查了几个领域的州法律,这些领域属于对优生学的狭义和广义理解,以确定有RBA禁令的州是否实施了更广泛的政策来抵制优生学。我的分析表明,他们通常没有。相反,明显的动机是利用对优生学的担忧来限制生育权利。这项立法任务是虚伪的,它伤害了受优生学运动影响的群体——少数民族、妇女、残疾人、LGBTQ+社区和移民。最终,它把我们引向了多布斯,它削弱了以前反对优生学的宪法保护,使每个人都容易受到托马斯谴责的优生学政策的影响。
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引用次数: 0
Chinese legal response to the shared motherhood model in lesbians' family-making. 中国法律对女同性恋共同母性模式的回应。
IF 3.4 2区 哲学 Q1 ETHICS Pub Date : 2023-01-01 DOI: 10.1093/jlb/lsad015
Chunyan Ding

Despite the non-recognition of same-sex relationships or marriage by the law, lesbian motherhood has become an emerging socio-legal issue in China. To fulfil their desires to reproduce and make a family, some Chinese lesbian couples adopt a `shared motherhood model' where one lesbian contributes an egg while her partner becomes pregnant through embryo transfer following artificial insemination with a donor's sperm. Because the shared motherhood model intentionally divides the roles of biological mother and gestational mother between lesbian couples, this has allowed legal controversies to emerge associated with the parenthood of the conceived child as well as custody, support of, and visitation of the child. There are two pending judicial cases involving a shared motherhood arrangement reported in the country. The courts have appeared reluctant to rule on them because Chinese law has not provided clear legal solutions to these controversial issues. They are highly cautious about delivering a decision not in line with the current legal position of non-recognition of same-sex marriage. Given little literature discussing Chinese legal responses to the shared motherhood model, this article aims to fill the gap by investigating the basis of parenthood under Chinese law and analysing the parentage issue concerning the different types of relationships between lesbians and children born of a shared motherhood arrangement.

尽管法律不承认同性关系或婚姻,但女同性恋母亲已经成为中国一个新兴的社会法律问题。为了满足生育和组建家庭的愿望,一些中国女同性恋夫妇采取了“共享母性模式”,即女同性恋一方提供卵子,而她的伴侣则通过人工授精后的胚胎移植怀孕。由于共同母性模式有意地将女同性恋伴侣之间的生母和孕母的角色分开,这就导致了与怀孕孩子的父母身份以及孩子的监护权、抚养权和探视权相关的法律争议。据报告,该国有两起涉及共同母亲安排的未决司法案件。法院似乎不愿就这些问题作出裁决,因为中国法律没有为这些有争议的问题提供明确的法律解决方案。他们对做出不符合目前不承认同性婚姻的法律立场的决定非常谨慎。鉴于很少有文献讨论中国法律对共同母性模式的回应,本文旨在通过调查中国法律下的亲子关系基础,并分析涉及女同性恋者与共同母性安排下出生的孩子之间不同类型关系的亲子关系问题,来填补这一空白。
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引用次数: 0
Who would own the HeLa cell line if the Henrietta Lacks case happened in present-day South Africa? 如果亨丽埃塔·拉克斯的案子发生在今天的南非,谁会拥有海拉细胞系?
IF 3.4 2区 哲学 Q1 ETHICS Pub Date : 2023-01-01 DOI: 10.1093/jlb/lsad011
Donrich W Thaldar

The HeLa cell line was created in 1951 without consent from Henrietta Lacks, the person whose tissue sample was used. In 2021, the descendants of Henrietta Lacks sued a well-known biotechnology company for the profits it made from the HeLa cell line. In this article, ownership of the cell lines is investigated from a South African legal perspective by considering three possible contemporary scenarios bearing points of similarity to the Henrietta Lacks case. In the first scenario, informed consent is obtained to use a tissue sample for research and to commercialize the products of such research; in the second scenario, informed consent is materially deficient because of an honest mistake on the part of the research institution; and in the third scenario, informed consent is materially deficient due to willful disregard of the law on the part of the research institution. In the first two scenarios, ownership of the cell line created from the tissue sample would vest in the research institution, and the research participant would not have any legal action for financial compensation. However, in the third scenario, ownership of the cell line would vest in the research participant, who would be able to claim all profits made from trading the cell line. Whether the research institution acted in good faith is therefore a crucial determinant of the legal outcome.

海拉细胞系是在1951年未经亨丽埃塔·拉克斯(Henrietta Lacks)同意的情况下创建的,她的组织样本被使用了。2021年,亨丽埃塔·拉克斯的后代起诉了一家知名生物技术公司,要求该公司从海拉细胞系中获利。在本文中,通过考虑与Henrietta Lacks案件相似的三种可能的当代情景,从南非法律角度调查了细胞系的所有权。在第一种情况下,获得知情同意,使用组织样本进行研究并将此类研究的产品商业化;在第二种情况下,由于研究机构的无心之失,知情同意存在重大缺陷;在第三种情况下,由于研究机构故意无视法律,知情同意在实质上是有缺陷的。在前两种情况下,从组织样本中产生的细胞系的所有权将归属于研究机构,研究参与者无需采取任何法律行动以获得经济赔偿。然而,在第三种情况下,细胞系的所有权将归属于研究参与者,他们将能够要求从交易细胞系中获得的所有利润。因此,研究机构的行为是否诚信是决定法律结果的关键因素。
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引用次数: 0
Allocating organs through algorithms and equitable access to transplantation-a European human rights law approach. 通过算法和公平的移植机会分配器官——这是欧洲人权法的做法。
IF 3.4 2区 哲学 Q1 ETHICS Pub Date : 2023-01-01 DOI: 10.1093/jlb/lsad004
Audrey Lebret

Digitization in transplantation is not a new phenomenon. Algorithms are being used, for example, to allocate organs based on medical compatibility and priority criteria. However, digitization is accelerating as computer scientists and physicians increasingly develop and use machine learning (ML) models to obtain better predictions on the chances of a successful transplant. The objective of the article is to shed light on the potential threats to equitable access to organs allocated through algorithms, whether these are the consequence of political choices made upstream of digitization or of the algorithmic design, or are produced by self-learning algorithms. The article shows that achieving equitable access requires an overall vision of the algorithmic development process and that European legal norms only partially contribute to preventing harm and addressing equality in access to organs.

移植中的数字化并不是一个新现象。例如,正在使用算法根据医疗兼容性和优先标准分配器官。然而,随着计算机科学家和医生越来越多地开发和使用机器学习(ML)模型来更好地预测移植成功的几率,数字化正在加速。本文的目的是阐明通过算法分配器官的公平获取所面临的潜在威胁,无论这些威胁是数字化或算法设计的上游政治选择的结果,还是由自我学习算法产生的。这篇文章表明,实现公平获取需要对算法开发过程有一个全面的认识,欧洲的法律规范只能部分地有助于防止伤害和解决获取器官的平等问题。
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引用次数: 0
Vaccination of individuals lacking decision-making capacity during a public health emergency. 在突发公共卫生事件中为缺乏决策能力的个人接种疫苗。
IF 3.4 2区 哲学 Q1 ETHICS Pub Date : 2022-07-01 DOI: 10.1093/jlb/lsac030
G Owen Schaefer, Tess Johnson, Ryan Friets, Sumytra Menon, Julian Savulescu

This paper explores the ethical challenges in deciding whether to vaccinate individuals lacking the decision-making capacity needed to provide informed consent during a public health emergency like COVID-19. The best interests standard ordinarily governs such decisions, which under the law in jurisdictions like England, Wales and Singapore takes into account the individual's past wishes and present preferences. However, in a public health emergency, the interests of third parties become more salient: those whom the unvaccinated individual might expose to infection have an interest in the individual's being vaccinated. While current mental capacity law has not been interpreted to take such public health considerations into account, we argue that such considerations are nevertheless ethically relevant, and can legitimately be weighed up alongside other considerations such as the preferences of the individual and impacts on their health. This is most relevant for individuals lacking decision-making capacity who have previously declined or presently resist vaccination. The public health impact of vaccination may in some instances be enough to outweigh preferences of the individual and justify providing vaccination against their past or present wishes.

本文探讨了在COVID-19等突发公共卫生事件中,在决定是否为缺乏知情同意所需决策能力的个人接种疫苗时面临的伦理挑战。根据英格兰、威尔士和新加坡等司法管辖区的法律,这类决定通常以最大利益标准为依据,考虑到个人过去的愿望和现在的偏好。然而,在突发公共卫生事件中,第三方的利益变得更加突出:那些未接种疫苗的个人可能暴露于感染的人对个人接种疫苗有兴趣。虽然目前的精神能力法没有被解释为考虑到这些公共卫生因素,但我们认为,这些考虑在伦理上仍然是相关的,并且可以合法地与其他考虑因素(如个人偏好及其对健康的影响)一起权衡。这与以前拒绝或目前抵制疫苗接种的缺乏决策能力的个人最为相关。在某些情况下,疫苗接种的公共卫生影响可能足以超过个人的偏好,并有理由违背他们过去或现在的意愿提供疫苗接种。
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引用次数: 1
Prescribing unproven cancer drugs: physician perspectives on expanded access and right to try. 处方未经证实的抗癌药物:医生对扩大获取和试用权的看法。
IF 3.4 2区 哲学 Q1 ETHICS Pub Date : 2022-07-01 DOI: 10.1093/jlb/lsac031
Haley Manley, Bryan A Sisk, Zubin Master, Christopher Thomas Scott

Background: For gravely ill patients who have no treatment options and who are ineligible for clinical trials, the US Food and Drug Administration (FDA) established the Expanded Access Program (EAP). Motivated by efforts to weaken FDA regulation and sold as providing greater access to experimental drugs, the federal Right to Try Act (RTT) was passed in 2017. It reduces FDA oversight by not requiring physicians to report safety data and foregoes approval of protocols by local institutional review boards.

Methods: This study explored the views of 17 neuro-oncologists from 15 different academic medical centers with varying experience with EAP and RTT using convenience sampling. We conducted semi-structured interviews and qualitative analysis to identify emerging themes.

Results: Most oncologists were confused between the two pathways, had little familiarity with RTT, and had little knowledge about experimental medicine available through either pathway. Oncologists reported a preference of enrolling patients in clinical trials over off-trial preapproval pathways with scant data. As a result, oncologists revealed concerns over properly evaluating risks for their patients.

Conclusion: Our findings suggest that neuro-oncologists need better resources and clearer mechanisms at their institutions to help navigate EAP and RTT in order to counsel patients interested in experimental medicine.

背景:对于没有治疗选择和不符合临床试验资格的重症患者,美国食品和药物管理局(FDA)建立了扩大准入计划(EAP)。在削弱FDA监管的努力的推动下,并以提供更多的实验药物为卖点,联邦《尝试权法案》(RTT)于2017年获得通过。它通过不要求医生报告安全数据和放弃当地机构审查委员会对协议的批准来减少FDA的监督。方法:本研究采用方便抽样的方法,对来自15个不同学术医疗中心的17名神经肿瘤学家在EAP和RTT方面的不同经验进行了探讨。我们进行了半结构化访谈和定性分析,以确定新出现的主题。结果:大多数肿瘤学家对这两种途径感到困惑,对RTT不太熟悉,对通过这两种途径获得的实验医学知识也知之甚少。肿瘤学家报告说,他们更倾向于让患者参加临床试验,而不是在数据不足的情况下进行非试验预批准。因此,肿瘤学家透露了对正确评估患者风险的担忧。结论:我们的研究结果表明,神经肿瘤学家在他们的机构中需要更好的资源和更清晰的机制来帮助他们导航EAP和RTT,以便为对实验医学感兴趣的患者提供建议。
{"title":"Prescribing unproven cancer drugs: physician perspectives on expanded access and right to try.","authors":"Haley Manley,&nbsp;Bryan A Sisk,&nbsp;Zubin Master,&nbsp;Christopher Thomas Scott","doi":"10.1093/jlb/lsac031","DOIUrl":"https://doi.org/10.1093/jlb/lsac031","url":null,"abstract":"<p><strong>Background: </strong>For gravely ill patients who have no treatment options and who are ineligible for clinical trials, the US Food and Drug Administration (FDA) established the Expanded Access Program (EAP). Motivated by efforts to weaken FDA regulation and sold as providing greater access to experimental drugs, the federal Right to Try Act (RTT) was passed in 2017. It reduces FDA oversight by not requiring physicians to report safety data and foregoes approval of protocols by local institutional review boards.</p><p><strong>Methods: </strong>This study explored the views of 17 neuro-oncologists from 15 different academic medical centers with varying experience with EAP and RTT using convenience sampling. We conducted semi-structured interviews and qualitative analysis to identify emerging themes.</p><p><strong>Results: </strong>Most oncologists were confused between the two pathways, had little familiarity with RTT, and had little knowledge about experimental medicine available through either pathway. Oncologists reported a preference of enrolling patients in clinical trials over off-trial preapproval pathways with scant data. As a result, oncologists revealed concerns over properly evaluating risks for their patients.</p><p><strong>Conclusion: </strong>Our findings suggest that neuro-oncologists need better resources and clearer mechanisms at their institutions to help navigate EAP and RTT in order to counsel patients interested in experimental medicine.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"9 2","pages":"lsac031"},"PeriodicalIF":3.4,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/03/17/lsac031.PMC9596169.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9146699","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Exploring access to genomic risk information and the contours of the HIPAA public health exception. 探索获得基因组风险信息和HIPAA公共卫生例外的轮廓。
IF 3.4 2区 哲学 Q1 ETHICS Pub Date : 2022-07-01 DOI: 10.1093/jlb/lsac034
Jennifer K Wagner, Juhi K Tanniru, Courtney A Chane, Michelle N Meyer

Considerable resources have been invested in research to identify pathogenic and likely pathogenic variants that cause morbidity and mortality and also in returning these results to patients. The public health impact and cost-effectiveness of these efforts are maximized when probands' relatives are informed of their risk and offered testing. However, such 'Traceback' cascade testing programs face multiple obstacles, including perceived or actual legal and regulatory hurdles. Here, using genetic cancer syndromes as a test case, we explore the contours of the Public Health Exception to the HIPAA Privacy Rule to assess whether it is a viable pathway for implementing a Traceback program. After examining the Privacy Rule as well as state laws and regulations for reportable conditions and genetic privacy, we conclude that this is not currently a viable approach for Traceback programs. We conclude by reflecting on ethical considerations of leveraging HIPAA's public health exception to disclose PHI directly to at-risk relatives and offering insights for how legal hurdles to such a Traceback program could be overcome, if desired.

已投入大量资源进行研究,以确定导致发病率和死亡率的致病和可能致病变异,并将这些结果反馈给患者。当先证者的亲属被告知其风险并提供检测时,这些努力的公共卫生影响和成本效益将最大化。然而,这种“回溯”级联测试项目面临多重障碍,包括感知到的或实际存在的法律和监管障碍。在这里,我们以遗传癌症综合征作为测试案例,探讨HIPAA隐私规则的公共卫生例外的轮廓,以评估它是否是实施追溯计划的可行途径。在审查了隐私规则以及关于可报告条件和基因隐私的州法律法规后,我们得出结论,这不是目前Traceback计划的可行方法。最后,我们反思了利用HIPAA的公共健康例外来直接向有风险的亲属披露PHI的道德考虑,并提供了如何克服此类追溯计划的法律障碍的见解,如果需要的话。
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引用次数: 0
Deconstructing age(s): an analysis of the different conceptions of age as a legal criterion for access to assisted reproductive technologies. 解构年龄:分析将年龄作为获得辅助生殖技术的法律标准的不同概念。
IF 3.4 2区 哲学 Q1 ETHICS Pub Date : 2022-07-01 DOI: 10.1093/jlb/lsac036
Andrea Martani, Eva De Clercq, Christian De Geyter, Guido Pennings, Tenzin Wangmo, Bernice Simone Elger

Whether there should be restrictions for access to Assisted Reproductive Technologies (ART) is a matter of continuous medical, societal, and ethico-legal debate. One of the most controversial topics in this context is the use of parental age as a criterion to limit access to ART. Views are divided on whether there should be an upper age limit for one or both parents and on where such limits should be. Although this debate is centered around the issue of 'age' and although age-related limits are present in many legislations, the intrinsic ambiguity of the term `age' is largely overlooked. In this article, we build on gerontological, medical, and sociological literature on the concepts of 'age' and 'aging' to distinguish three conceptions of age that are relevant for ART regulation: the chronological, the biological, and the social-cultural one. Beyond mapping out these conceptions of age, we describe how they relate to ART and reproduction, and illustrate the advantages and disadvantages of relying on each of them as a basis for limiting ART access. Finally, we propose a template for defining legal age limits for ART access in the law, based on the refined understanding of the different conceptions of age that we outline and we discuss two potential objections to our proposal.

是否应该限制获得辅助生殖技术(ART)是一个持续的医学、社会和伦理法律辩论的问题。在这方面最具争议的话题之一是使用父母年龄作为限制获得抗逆转录病毒治疗的标准。对于父母一方或双方是否应该有年龄上限,以及年龄上限应该在哪里,人们的看法存在分歧。尽管这场辩论围绕着“年龄”问题展开,尽管许多立法中都存在与年龄相关的限制,但“年龄”一词内在的模糊性在很大程度上被忽视了。在本文中,我们以老年学、医学和社会学文献为基础,对“年龄”和“衰老”的概念进行了区分,以区分与ART调控相关的三个年龄概念:时间、生物和社会文化。除了绘制这些年龄概念之外,我们还描述了它们与ART和生殖的关系,并说明了依赖它们作为限制ART获取的基础的优点和缺点。最后,基于对我们所概述的不同年龄概念的精细化理解,我们提出了一个在法律中定义ART获取的法定年龄限制的模板,并讨论了对我们建议的两种潜在反对意见。
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引用次数: 0
Mifepristone, preemption, and public health federalism. 米非司酮,优先权和公共卫生联邦制。
IF 3.4 2区 哲学 Q1 ETHICS Pub Date : 2022-07-01 DOI: 10.1093/jlb/lsac037
Patricia J Zettler, Annamarie Beckmeyer, Beatrice L Brown, Ameet Sarpatwari

On June 24, 2022, the Supreme Court issued an opinion in which five justices voted to overturn Roe v Wade. Even before the final opinion issued, scholars and advocates had begun to consider legal strategies that might mitigate the decision's anticipated harmful consequences. One such strategy involves challenging state restrictions on Food and Drug Administration (FDA)-approved pregnancy termination drugs on preemption grounds. This article begins by exploring how these challenges might fare-considering both drug-specific restrictions and complete bans on abortion-arguing that there are compelling legal grounds on which courts should conclude that many state restrictions are preempted. Importantly, although these state restrictions have arisen within a larger debate about reproductive health care, this is far from the only area in which states seek to regulate prescription drugs. States have long regulated drugs in ways that diverge from FDA, arguably increasingly so in recent years. Accordingly, the article investigates the implications that preemption challenges in the abortion context may have for other areas of state drug regulation, making the case that the benefits of public health federalism need not be undermined by successful preemption challenges in the abortion arena.

2022年6月24日,最高法院发表了一项意见,五名法官投票推翻了罗伊诉韦德案。甚至在最终意见发表之前,学者和倡导者就已经开始考虑可能减轻该决定预期的有害后果的法律策略。其中一个策略是挑战国家对食品和药物管理局(FDA)批准的终止妊娠药物的限制,以先发制人的理由。这篇文章首先探讨了这些挑战将如何进行——考虑到特定药物的限制和完全禁止堕胎——认为有令人信服的法律依据,法院应该据此得出结论,许多州的限制是先发制人的。重要的是,尽管这些州的限制是在关于生殖保健的更大辩论中出现的,但这远非各州寻求监管处方药的唯一领域。长期以来,各州对药品的监管方式与FDA有所不同,可以说近年来这种情况越来越严重。因此,本文调查了堕胎方面的先发制人挑战可能对州药物监管的其他领域产生的影响,论证了公共卫生联邦制的好处不必因堕胎领域成功的先发制人挑战而受到损害。
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引用次数: 2
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