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Why the South African National Health Research Ethics Council is wrong about ownership of human biological material and data 为什么南非国家卫生研究伦理委员会在人类生物材料和数据的所有权问题上是错误的。
IF 1 3区 哲学 Q3 ETHICS Pub Date : 2025-02-03 DOI: 10.1111/dewb.12475
Donrich Thaldar, Uyanda Maboea, Amy Gooden

The South African National Health Research Ethics Council (NHREC) states in its 2024 Ethics Guidelines that human biological material (HBM) and data cannot be privately owned under South African law. This position conflicts with established legal principles, guidelines by the Health Professions Council of South Africa (HPCSA), and South African university policies, all of which support private ownership of HBM and data. Private ownership is not only legally sound but also ethically necessary, providing a framework for accountability, ensuring fair recognition of institutional contributions, and enabling responsible custodianship over these valuable resources. The NHREC's denial of private ownership of HBM and data undermines South African research institutions’ ability to control their research assets and leaves them vulnerable to exploitation by foreign entities. The NHREC should issue a corrigendum to delete its incorrect position on private ownership of HBM and data.

南非国家卫生研究伦理委员会(NHREC)在其2024年伦理准则中指出,根据南非法律,人类生物材料(HBM)和数据不能为私人所有。这一立场与既定的法律原则、南非卫生专业委员会(HPCSA)的指导方针以及南非大学政策相冲突,所有这些政策都支持HBM和数据的私人所有权。私有制不仅在法律上是合理的,而且在道德上也是必要的,它提供了一个问责制框架,确保对机构贡献的公平承认,并能够对这些宝贵资源进行负责任的管理。NHREC拒绝私人拥有HBM和数据,破坏了南非研究机构控制其研究资产的能力,并使它们容易受到外国实体的利用。NHREC应该发布一份更正,删除其关于HBM和数据私人所有权的错误立场。
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引用次数: 0
A quarter of a century Developing World Bioethics – An invitation to you, our readers 发展中国家的生命伦理学——对你的邀请,我们的读者。
IF 0.9 3区 哲学 Q3 ETHICS Pub Date : 2025-02-03 DOI: 10.1111/dewb.12476
Udo Schuklenk

When Willem Landman and I both met in South Africa twenty-five years ago - he a recent returnee from a lengthy stint as a bioethics professor in the United States, and me, an expat academic on a mission to establish a new bioethics unit at the Wits University's Faculty of Health Sciences in Johannesburg - we both agreed that we ought to do something about the lack of quality bioethics content relevant to but also from the global south. Research ethics training programmes, for instance, that were conducted by WHO and other international groups consisted at the time very much of content produced by well-meaning faculty in the global north and were directed at faculty in the global south. These activities, well-intentioned as they were, also constituted arguably ideology transfer in matters deemed ethics. There was little ‘homegrown’ academic bioethics capacity to speak of.

Much has thankfully changed since then. Flourishing bioethics programmes exist across the globe in the global south. Not to the same extent as in the global north, but they do exist, and they make their existence known both at home as well as on the international stage. There is still a somewhat uncomfortable dependence on the largesse of wealthy international funders to be reported, in terms of what research is undertaken, for instance. However, many programmes succeed today as their counterparts in the global north succeed, by teaching health sciences and life sciences students bioethics and medical ethics. ‘Hard money’ earned through teaching in universities matters as much in the global south as it matters in the global north!

Developing World Bioethics has been the target of some criticism because we made clear some years ago that we would not publish content of a religious nature such as, for instance, interpretations of particular religious scriptures. We still see ourselves in a tradition that understands ethics as an impartial enterprise seeking universal ethical truths. They cannot be found in sectarian approaches to ethics. Strangely, among the charges leveled against us were ‘colonialism’ and ‘epistemic injustice’. Let me merely note regarding the former, the religious content we have received over the years invariably was content unthinkable without the influence of colonialism that spread monotheistic ideologies (often violently) across continents. And while the ‘epistemic injustice’ charge tends to also be deployed liberally by critics, it's never quite clearly what it actually entails with regard to this journal, and how it is applicable to us, if at all.

However, given that bioethics is no longer ‘virgin’ territory in the global south, it seems right for us, as the co-editors of Developing World Bioethics, to ask you, our readers, what kinds of content you would like to see in the journal. What topics do you think have authors, who submitted their content successful upon review to the journal, neglected? Why do you think those t

25年前,当Willem Landman和我在南非相遇时——他刚从美国长期担任生命伦理学教授归来,而我是一名外派学者,在约翰内斯堡的Wits大学健康科学学院建立一个新的生命伦理学单位——我们都同意,我们应该做些什么来解决缺乏高质量的生物伦理学内容的问题,这些内容既与南半球相关,也来自南半球。例如,世卫组织和其他国际团体开展的研究伦理培训方案,当时大部分内容是由全球北方善意的教员制作的,针对的是全球南方的教员。这些活动虽然是出于好意,但也构成了道德问题上的意识形态转移。几乎没有什么“本土的”学术生物伦理能力可言。自那以后,很多事情都发生了可喜的变化。在全球南部,蓬勃发展的生物伦理项目遍布全球。与全球北方的程度不同,但它们确实存在,而且它们在国内和国际舞台上都让人知道自己的存在。例如,就所进行的研究而言,对富有的国际资助者的慷慨捐赠的依赖仍然有些令人不安。然而,今天许多方案取得了成功,就像全球北方的同类方案一样,它们通过向健康科学和生命科学学生教授生物伦理学和医学伦理学而取得成功。通过大学教学挣来的“辛苦钱”在南半球和北半球同样重要!《发展中世界生命伦理学》一直是一些批评的目标,因为我们几年前就明确表示,我们不会发表具有宗教性质的内容,例如对特定宗教经典的解释。我们仍然认为自己处于这样一种传统,即把伦理学理解为一项寻求普遍伦理真理的公正事业。它们不能在宗派主义的伦理方法中找到。奇怪的是,在针对我们的指控中有“殖民主义”和“认识上的不公正”。关于前者,我只想指出,如果没有殖民主义的影响,我们多年来收到的宗教内容总是不可想象的,殖民主义在各大洲传播一神论意识形态(通常是暴力的)。虽然“认识上的不公正”的指控也倾向于被批评者自由地使用,但它从来没有很清楚它实际上涉及到这本杂志,以及它如何适用于我们,如果有的话。然而,鉴于生命伦理学在南半球不再是“处女地”,作为《发展中国家生物伦理学》的共同编辑,我们似乎应该问你们,我们的读者,你们希望在期刊上看到什么样的内容。您认为哪些主题的文章被忽视了,而这些作者的文章在期刊评审中获得了成功?为什么你认为这些话题值得骄傲的出版地点?“认识上的不公正”是一个真正的问题,阻止你向《发展中世界生物伦理学》提交你的内容吗?如果是这样,解释一下这是如何影响你在哪里提交研究文章的决策的,这样我们就有机会在给作者的指导方针中解决这个问题。如果有的话,你认为期刊采用了哪些你认为无法克服的认知障碍?一种确保你认为重要的话题进入《发展中国家生物伦理学》的方法是自愿担任该杂志特刊的客座编辑。黛博拉·迪尼兹和我都很乐意讨论你的想法。您可以通过我们的编辑部联系我们。我们只是一封邮件的距离。另一种确保你认为应该引起同事注意的话题的方法是向我们推荐一篇客座社论,你可以——评论风格,就像我在这篇社论中所做的那样——以相对简短的形式阐述你的观点,比同行评议期刊文章所需的时间投入要少。把这篇社论作为一个开放式的邀请,让我们知道你认为我们不足的地方,建议如何使这本杂志对你更有用,并且让我们知道你认为我们应该在这本出版物中涵盖的主题。作者声明不存在利益冲突。
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引用次数: 0
Medical ethics on research-related organ donation and transplantation in China 中国研究相关器官捐献与移植的医学伦理。
IF 0.9 3区 哲学 Q3 ETHICS Pub Date : 2025-01-15 DOI: 10.1111/dewb.12474
Zhu Liduzi Jiesisibieke, Tao-Hsin Tung
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引用次数: 0
Dual-use research assessment in emerging medical biotechnology: An ethical perspective from China 新兴医学生物技术的双重用途研究评估:来自中国的伦理视角。
IF 1 3区 哲学 Q3 ETHICS Pub Date : 2024-12-11 DOI: 10.1111/dewb.12472
Xiaonan Wang, Xiaomei Zhai

Emerging medical biotechnology, with its dual-use nature, presents both unprecedented opportunities and challenges for human society. As we benefit from technological innovation, it is crucial for Chinese academics and policymakers to effectively identify and address potential risks. However, the current framework for evaluating dual-use research faces multiple challenges, including difficulties in identifying dual-use issues, a lack of consideration for broader impacts in assessments, and a lack of consensus on balancing benefits and risks. Furthermore, inadequacies in the review mechanism, such as uneven progress among institutions, insufficient review capabilities, and lacking specialized knowledge among assessment personnel, hamper the effectiveness of evaluation efforts. This article aims to explore these challenges and propose practical recommendations for strengthening the evaluation and governance mechanisms of dual-use research. By effectively mitigating the risks associated with dual-use research, it facilitates the promotion of responsible scientific progress in emerging medical biotechnologies in China and internationally.

新兴的医学生物技术具有双重用途,给人类社会带来了前所未有的机遇和挑战。随着我们从技术创新中获益,中国学者和政策制定者有效识别和应对潜在风险至关重要。然而,目前评估军民两用研究的框架面临多重挑战,包括难以确定军民两用问题,评估中缺乏对更广泛影响的考虑,以及在平衡利益和风险方面缺乏共识。此外,审查机制的不足,如机构间进展不平衡、审查能力不足、评估人员缺乏专业知识等,影响了评估工作的有效性。本文旨在探讨这些挑战,并为加强军民两用研究的评估和治理机制提出切实可行的建议。通过有效降低与军民两用研究相关的风险,它有助于促进中国和国际新兴医学生物技术的负责任的科学进步。
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引用次数: 0
THANK YOU TO DEVELOPING WORLD BIOETHICS REVIEWERS 感谢发展中国家生物伦理审查员
IF 0.9 3区 哲学 Q3 ETHICS Pub Date : 2024-12-09 DOI: 10.1111/dewb.12473
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引用次数: 0
Feasibility of implementing the elective oocyte cryopreservation in China: A case study 中国实施选择性卵母细胞冷冻保存的可行性:个案研究。
IF 1 3区 哲学 Q3 ETHICS Pub Date : 2024-12-02 DOI: 10.1111/dewb.12471
Yijing Xie, Xiaomei Zhai

In China, a prominent case exists wherein a medically fit woman filed a lawsuit against a hospital for denying her request to undergo oocyte cryopreservation. She contended the hospital had infringed upon her rights. This paper focuses on medicalization and gender equality to discuss whether or not a hospital can infringe upon a woman's rights. We believe elective oocyte cryopreservation is not a medical treatment and it may lead to an overwhelming utilization of extensive medical resources. Reproductive medicine may face the risk of resource commercialization due to the practice of selective egg freezing. There are physiological disparities between males and females. The ability of men to cryopreserve sperm does not necessarily extend to a woman's capacity for oocyte cryopreservation. We contend that the application of this technology should continue to adhere to the principle of prudence.

在中国,有一个著名的案例,一名身体健康的妇女起诉一家医院,因为医院拒绝了她进行卵母细胞冷冻保存的请求。她声称医院侵犯了她的权利。本文主要从医疗化和性别平等两个方面来探讨医院是否可以侵犯妇女的权利。我们认为选择性卵母细胞冷冻保存不是一种医学治疗,它可能导致大量医疗资源的压倒性利用。选择性冷冻卵子的做法可能会使生殖医学面临资源商业化的风险。男女之间存在着生理上的差异。男性冷冻保存精子的能力并不一定延伸到女性冷冻保存卵子的能力。我们认为,这项技术的应用应继续坚持谨慎的原则。
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引用次数: 0
Adults aged 65 years and older in South Africa have a responsibility to vaccinate against influenza 南非 65 岁及以上的成年人有责任接种流感疫苗。
IF 1 3区 哲学 Q3 ETHICS Pub Date : 2024-11-18 DOI: 10.1111/dewb.12470
Ruach Sarangarajan, Cornelius Ewuoso

In this article, we draw on the thinking about incompleteness and conviviality grounded in Afro-communitarianism ethics from the Global South to argue that adults aged 65 years and above have a prima facie responsibility to vaccinate against influenza. Notably, adults aged 65 years and above have a duty of conviviality to act in ways that limit harm to them and others. This article is intrinsically valuable to promote epistemic justice, thereby contributing towards the decolonisation of the global healthcare system. Moreover, this project has social significance in contributing to mitigation efforts against future public health challenges associated with population ageing in resource-limited developing African nations, wherein the impact of population transition will be felt most.

在本文中,我们借鉴全球南部非洲社群主义伦理学中关于不完整性和集体性的思想,认为 65 岁及以上的成年人有初步责任接种流感疫苗。值得注意的是,65 岁及以上的成年人有责任以限制对自己和他人造成伤害的方式行事。这篇文章的内在价值在于促进认识论正义,从而为全球医疗保健系统的非殖民化做出贡献。此外,本项目还具有社会意义,有助于缓解资源有限的非洲发展中国家未来因人口老龄化而面临的公共卫生挑战,因为人口老龄化对这些国家的影响最大。
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引用次数: 0
Revision of a self-assessment tool for research ethics committees in low- and middle-income countries: Incorporation of elements that safeguard participants' rights and welfare 修订中低收入国家研究伦理委员会的自我评估工具:纳入保障参与者权利和福利的要素。
IF 1 3区 哲学 Q3 ETHICS Pub Date : 2024-11-14 DOI: 10.1111/dewb.12469
Hany Sleem, Henry J. Silverman

Evaluating the quality of research ethics committees (RECs) is crucial but challenging due to the difficulty of developing meaningful quality measures. Recently, commentators assessed ten quality instruments for RECs, including the Research Ethics Committee Quality Assurance Self-Assessment Tool developed for RECs in the Arab Middle East. They identified several missing items in this tool regarding safeguarding participants' rights and welfare.

To address these gaps, we aimed to redesign the tool. Using the Delphi method, we involved 15 REC chairs to provide feedback and recommendations for a revised tool. This process led to a modified instrument that incorporated the missing items and additional elements regarding the monitoring of research conduct (an essential oversight function of RECs), and the independence of the RECs from institutional and external influences.

We conclude that the revised tool effectively addresses the quality of RECs by including elements relevant to participant outcomes, board deliberations, and participant protection. The added focus on ethics oversight enhances its robustness, significantly impacting participants' rights and welfare.

评估研究伦理委员会 (REC) 的质量至关重要,但由于难以制定有意义的质量衡量标准,评估工作充满挑战。最近,评论者评估了 REC 的十种质量工具,包括为阿拉伯中东地区 REC 开发的研究伦理委员会质量保证自我评估工具。他们在该工具中发现了几个有关保障参与者权利和福利的缺失项。为了弥补这些缺失,我们打算重新设计该工具。我们采用德尔菲法,让 15 位区域选举中心主席为修订工具提供反馈和建议。在此过程中,我们修改了工具,纳入了缺失的项目,并增加了有关监督研究行为(REC 的基本监督职能)以及 REC 独立于机构和外部影响的内容。我们的结论是,修订后的工具通过纳入与参与者结果、董事会审议和参与者保护相关的要素,有效地解决了研究伦理委员会的质量问题。对伦理监督的额外关注增强了其稳健性,对参与者的权利和福利产生了重大影响。
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引用次数: 0
From COVID-19 to mpox vaccine hoarding - Has the Global North learned its global health lessons? 从 COVID-19 到囤积麻风腮疫苗--全球北方是否吸取了全球卫生方面的教训?
IF 0.9 3区 哲学 Q3 ETHICS Pub Date : 2024-10-24 DOI: 10.1111/dewb.12468
Udo Schuklenk
<p>During the COVID-19 pandemic many writers decried the global north's hoarding of COVID-19 vaccines. The response ranged from authors calling said hoarding tamely ‘unethical’1 or, more aggressively, labeling this conduct as ‘Vaccine Apartheid.’2 Now that we have established that at a certain point in time in a WHO declared ‘public health emergency of international concern’3 vaccine hoarding becomes ethically problematic, how are things playing out in the currently ongoing mpox outbreak on the African continent? After all, in August this year the WHO declared just that. The Africa Centres for Disease Control and Prevention declared the mpox outbreak ‘a public health emergency of continental security’.4 This clearly constitutes a call to arms, both directed at partners in the global north, as well as to African governments, to take this outbreak seriously, and to commit the resources required to address it efficiently.</p><p>Mpox was first described in the Democratic Republic of Congo (DRC) in 1970. At the time of writing this editorial, it is spreading rapidly in a number of African countries, including Burundi, Kenya, and Uganda, countries where mpox had never been reported before. Since then, it has also spread to South Africa and caused disease and death there, as well as to Sweden and Thailand. Such is the nature of global travel that an illness that is often sexually transmitted moves around quickly. At greatest risk of death are seemingly young children and people living with compromised immune systems, which undoubtedly will include many in sub-Saharan Africa who don't have reliable access to HIV medication.</p><p>At this point in time the DRC ‘remains the epicentre of disease, accounting for 96% of new cases and deaths.’ It is estimated that the currently affected African countries require about 10 million vaccine doses to get the mpox outbreak under control. Only around 2.6-3.6 million doses are available, and countries of the global north haven't donated what is needed, despite having uncontroversial ethical obligations to do so.5<sup>,</sup>6</p><p>Of course, there will be much talk about the need for transparency, but African countries’ governments will recall what happened after they reported truthfully the discovery of the COVID-19 Omicron variant. Racist, punitive travel bans were issued, and the harms they did to African people was much worse than anything caused by Omicron. None of that travel ban grandstanding implemented in many nation states, partly in order to avoid inflaming already existing xenophobic sentiments, prevented the rapid spread of the variant across the globe. One would hope Western governments have learned relevant lessons from this.</p><p>As a result of the failure of the global north to provide COVID-19 vaccines to people in the global south in a timely fashion, the WHO's legally binding International Health Regulations (IHR) were updated to include equitable access to lifesaving countermeasures. The IHR als
在COVID-19大流行期间,许多作家谴责全球北方囤积COVID-19疫苗。作者们的反应不一,有的称这种囤积是“不道德的”,有的则更为激进地将这种行为称为“疫苗种族隔离”。现在我们已经确定,在世卫组织宣布的“国际关注的突发公共卫生事件”的某个时间点,囤积疫苗在道德上存在问题,那么目前正在非洲大陆爆发的麻疹疫情的情况如何呢?毕竟,今年8月世界卫生组织就这样宣布了。非洲疾病控制和预防中心宣布麻疹的爆发是“大陆安全的突发公共卫生事件”这显然是对全球北方伙伴和非洲各国政府发出的战斗呼吁,要求它们认真对待这一疫情,并承诺提供有效应对这一疫情所需的资源。麻疹于1970年在刚果民主共和国首次被发现。在撰写这篇社论时,麻疹正在包括布隆迪、肯尼亚和乌干达在内的一些非洲国家迅速传播,这些国家以前从未报告过麻疹。从那时起,它也蔓延到南非,并在那里以及瑞典和泰国造成疾病和死亡。这就是全球旅行的本质,一种通常通过性传播的疾病传播得很快。死亡风险最大的是看似年幼的儿童和免疫系统受损的人,这无疑包括撒哈拉以南非洲的许多人,他们无法可靠地获得艾滋病毒药物。目前,刚果民主共和国仍然是疾病中心,占新发病例和死亡病例的96%。据估计,目前受影响的非洲国家需要大约1000万剂疫苗才能控制麻疹疫情。只有大约260万至360万剂疫苗可供使用,而全球北方国家还没有捐赠所需的疫苗,尽管它们有这样做的无可争议的伦理义务。5,6当然,关于透明度的必要性会有很多讨论,但非洲国家政府会回忆起他们如实报告发现新冠病毒欧米克隆变异后发生的事情。种族主义的、惩罚性的旅行禁令被颁布,它们对非洲人民造成的伤害比欧米克隆造成的任何伤害都要严重得多。在许多民族国家实施的旅行禁令,部分是为了避免激起已经存在的仇外情绪,并没有阻止这种变体在全球的迅速传播。人们希望西方政府能从中吸取相关的教训。由于全球北方未能及时向全球南方人民提供COVID-19疫苗,世卫组织更新了具有法律约束力的《国际卫生条例》,以包括公平获得挽救生命的对策。《国际卫生条例》还明确要求各国避免实施不必要的旅行禁令。看看这在现实政治中意味着什么将会很有趣。麻疹通常是通过性行为传播的,包括男性与其他男性发生性行为。相当多的非洲国家最近已立法将此类性活动定为犯罪。撇开其他人权考虑不提,这些措施会适得其反,因为它们将使那些有风险的人在疫苗可用时不太可能考虑接种疫苗。正如Larry Gostin及其同事在最近的一篇社论中指出的那样,全球北方国家可以获得大量的mpox疫苗,然而,作为对世卫组织声明的回应,美国只捐赠了区区5万剂,欧盟又提供了20万剂当非洲大陆的疫情无法得到控制并最终蔓延到全球时,这里展示的囤积疫苗很可能适得其反。虽然这种传播与COVID-19病毒完全不同,但由于其性传播性,它仍可能影响更多的人。在北美和欧洲,人群对麻疹的免疫力都很低,使这些国家的人们容易受到全球疫情的影响。最好的解决办法是防止全球爆发,但目前做得太少,无法做到这一点。看起来,全球北方的政府似乎没有从2019冠状病毒病大流行期间的全球卫生失败中吸取多少教训。
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引用次数: 0
Moral challenges and understanding of clinical ethics in Tanzanian hospitals: Perspectives of healthcare professionals 坦桑尼亚医院面临的道德挑战和对临床伦理的理解:医护人员的观点。
IF 1 3区 哲学 Q3 ETHICS Pub Date : 2024-10-19 DOI: 10.1111/dewb.12467
Shija Kevin Kuhumba, Bert (A.C) Molewijk, Jan Helge Solbakk, Nandera Ernest Mhando, Trygve Johannes Lereim Sævareid

Healthcare professionals encounter many moral challenges in their daily clinical practice. However, there have been few studies on the subject matter in Tanzania. This study aims to provide an account of moral challenges faced by healthcare professionals in Tanzanian hospitals, their understanding of clinical ethics, and the ethics education they have received. Many participants reported receiving some kind of ethics training through formal education and on-the-job training. Some participants understood ethics in healthcare settings as adherence to established laws, regulations, guidelines, procedures, norms, and rules essential in clinical practice. Analysis of the data identified four themes of moral challenges. These challenges are related to 1) decision-making and communication in clinical practice, 2) scarcity of medical resources and prioritization in clinical practice, 3) withdrawal of curative treatment, and 4) conflicts between professional judgment, religious convictions and adherence to alternative treatments. Based on the findings, we suggest a context-sensitive form of clinical ethics training to prepare healthcare professionals to recognize and address these moral challenges.

医护人员在日常临床实践中会遇到许多道德挑战。然而,坦桑尼亚在这方面的研究却很少。本研究旨在介绍坦桑尼亚医院医护人员所面临的道德挑战、他们对临床伦理的理解以及他们所接受的伦理教育。许多参与者表示通过正规教育和在职培训接受了某种伦理培训。一些参与者将医疗机构的伦理理解为遵守既定的法律、法规、指导方针、程序、规范和临床实践中必不可少的规则。对数据的分析确定了道德挑战的四个主题。这些挑战涉及:1)临床实践中的决策和沟通;2)医疗资源稀缺和临床实践中的优先顺序;3)放弃治疗;4)专业判断、宗教信仰和坚持替代疗法之间的冲突。根据研究结果,我们建议开展一种对具体情况有敏感认识的临床伦理培训,使医护人员做好准备,认识并应对这些道德挑战。
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引用次数: 0
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Developing World Bioethics
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