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Ethical analysis of informed consent methods in longitudinal cohort studies: A Chinese perspective 纵向队列研究中知情同意方法的伦理分析:中国视角
IF 2.2 3区 哲学 Q3 ETHICS Pub Date : 2024-09-13 DOI: 10.1111/dewb.12460
Kun Li, Mingtao Huang, Xiaomei Zhai, Chen Wang
In longitudinal cohort studies involving large populations over extended periods, informed consent entails numerous urgent challenges. This paper explores challenges regarding informed consent in long‐term, large‐scale longitudinal cohort studies based on the longitudinal and dynamic nature of such research. It analyzes and evaluates widely recognized broad consent and dynamic consent methods, highlighting limitations concerning their ability to adapt to evolving research objectives and participant perspectives. This paper discusses trust‐based informed consent and emphasizes the needs to establish and maintain trust with research participants and to balance information disclosure with respect for participants' autonomy. Informed consent in long‐term studies is an evolving process that must adapt to changing research environments. Based on participant trust, researchers should observe and assess potential research risks. Finally, the paper recommends enhancing institutional credibility, implementing reconsent procedures, and ensuring robust ethical oversight to safeguard participants' rights despite the complexity of modern biomedical research.
在涉及大量人群的长期纵向队列研究中,知情同意会带来许多紧迫的挑战。本文基于此类研究的纵向和动态性质,探讨了长期、大规模纵向队列研究中的知情同意所面临的挑战。本文分析并评估了广泛认可的广泛同意和动态同意方法,强调了这些方法在适应不断变化的研究目标和参与者观点方面的局限性。本文讨论了以信任为基础的知情同意,强调需要建立并保持与研究参与者的信任,并在信息披露与尊重参与者自主权之间取得平衡。长期研究中的知情同意是一个不断发展的过程,必须适应不断变化的研究环境。在参与者信任的基础上,研究人员应观察和评估潜在的研究风险。最后,本文建议,尽管现代生物医学研究十分复杂,但仍要提高机构的可信度,实施重新同意程序,并确保强有力的伦理监督,以保障参与者的权利。
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引用次数: 0
Social disharmony, inauthenticity and patriarchy: an Ubuntu perspective on the practice of female genital mutilation. 社会不和谐、不真实和父权制:从乌班图视角看待切割女性生殖器的做法。
IF 0.9 3区 哲学 Q3 ETHICS Pub Date : 2024-09-07 DOI: 10.1111/dewb.12464
Tauseef Ahmad Ally, Lizeka Amanda Tandwa

Female Genital Mutilation (FGM) is a universal issue which affects girls in Africa, the Middle East, Asia and South America, and immigrant communities in Western Europe, North America, Australia and New Zealand. FGM is a cultural practice in approximately 29 countries in Africa, affecting over 140 million girls. FGM is practiced as a rite of passage, where girls are initiated into womanhood. This practice is promoted as a means for incorporation, thus ascribing personhood, and belonging for girls to their communities. African scholars hold conflicting positions about FGM, with some arguing that it is essential for relational fullness and harmony. While others believe FGM is unjustified because of the health and social risks associated with the practice. We argue, applying sustainable social harmony and Gyekye's views on cultural revitalization, that FGM is morally unjustified and should be prohibited. We believe the claims that FGM fosters harmony, a value of Ubuntu, are fallacious, and this perceived harmony is pretentious and unsustainable. We claim that FGM is inauthentic, unjust and steeped in patriarchal underpinnings that are unsustainable, thus it is a disharmonious practice. Cultural practices that are disharmonious should be refined and pruned and must be dynamic and responsive to current realities.

切割女性生殖器(FGM)是一个普遍问题,影响着非洲、中东、亚洲和南美洲的女童,以及西欧、北美、澳大利亚和新西兰的移民社区。切割女性生殖器是非洲约 29 个国家的一种文化习俗,影响到 1.4 亿多女童。切割女性生殖器是一种成年仪式,是女孩成为女人的开始。这种习俗被视为融入社会的一种手段,从而赋予女孩人格和对其社区的归属感。非洲学者对女性外阴残割持有不同的立场,有些人认为这种做法对人际关系的完整与和谐至关重要。而另一些学者则认为,切割女性生殖器官是不合理的,因为这种做法会带来健康和社会风险。我们认为,根据可持续的社会和谐和 Gyekye 关于文化振兴的观点,切割女性生殖器在道德上是不合理的,应予以禁止。我们认为,切割女性生殖器能促进和谐--"乌班图 "的价值观--的说法是荒谬的,这种所谓的和谐是自命不凡的,是不可持续的。我们认为,女性外阴残割是不真实、不公正的,其父权制的根基是不可持续的,因此它是一种不和谐的习俗。不和谐的文化习俗应加以改进和修剪,必须充满活力,顺应当前的现实。
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引用次数: 0
Oropouche fever in Brazil: When the time is now 巴西的奥罗普切热时不我待
IF 0.9 3区 哲学 Q3 ETHICS Pub Date : 2024-08-28 DOI: 10.1111/dewb.12463
Debora Diniz, Luciana Brito, Giselle Carino, Alessandra Hora dos Santos
<p>“We have the right to be informed of the latest scientific learnings in real time. Ultimately, it falls upon us to inform and care for these families, women, and children”, states Alessandra Hora dos Santos, who cosigns this editorial. Ms. Hora dos Santos oversees one of the several community-level non-governmental organizations created to safeguard the needs and rights of women and their children affected by the Zika virus in Brazil, “Família de Anjos”.</p><p>Brazil has a public health system, but the needs of children with Zika congenital syndrome are diverse and demand a strong connection between providers and facilities: from adapted transportation for mobility to daily physiotherapy, from access to home care for more dependent children to access to high-cost medicines. Família de Anjos leads political advocacy to prioritize Zika-affected children's treatment and offers some public-private partnership services. They connect around 400 women and their families in Alagoas, a small state in the poor Northeast, where Zika has hit communities dramatically since 2015.1 When Ms. Hora dos Santos emphasizes the organization's role in providing care, she highlights how the experience of health emergencies has different timings for communities and policies, for the lived experience of people and the abstraction of numbers. While an epidemic may be over in terms of health policies and surveillance guidelines, it can be a long-lasting experience for those most affected by it.2</p><p>Brazil has been the epicenter of two significant public health emergencies that have had a profound impact on women of reproductive age. The initial outbreak of the Zika virus occurred in 2015, with a subsequent decline in new cases over the past six years. However, the risk to women residing in endemic mosquito zones persists. Ms. Hora's organization has received approximately eight cases of Zika-affected children each year since the epidemic was declared to be over by the Brazilian Ministry of Health. The second health emergency was the global pandemic of the Covid-19 virus, which has resulted in elevated maternal mortality rates in the same zones as those most affected by Zika.3 Moreover, children with Zika faced interrupted treatment during the pandemic due to the lack of services, medicines, and social distancing.4</p><p>In July 2024, a new threat emerged in the conversations of the WhatsApp groups in which Ms. Hora participated with other women: Oropouche fever. The Oropouche virus has been circulating in Brazil for several decades mostly confined to the North region but has recently migrated to different parts of the country due to environmental changes. The vectors are another well-known mosquito in the communities, where the first cases of adult deaths, spontaneous abortion, stillbirth, or the birth of newborns with microcephaly –all tell-tale signs of Oropouche– have been reported.5 The symptoms of Oropouche fever are quite similar to other febrile arbovirus, incl
对于生活在奥罗普切病毒目前通过病媒蚊子传播的地区的育龄妇女来说,现在有一种紧迫感:这可能会对她们的生活产生长期影响,类似于在寨卡疫情中观察到的影响。问题是,如何平衡延长研究时间的需要和采取预防措施的需要,以便在调查发现新的因果关系时提供预期保护。霍拉女士认为,应对措施很简单:作为全面准备工作的一部分,开辟永久性的沟通渠道并采取预防措施。这不仅仅需要发布监测公告,还需要找到新的沟通方式,解释垂直传播假说的不确定性,同时将妇女和其他育龄人群置于医疗保健决策的中心。在公共卫生突发事件中,最初的病例被称为 "零号病人"。他们代表着疫情爆发时,风险事件甚至还未被视为现实的时期--奥罗普切地区的妇女希望更详细地了解这段历史的前尘往事,以了解她们现在有多么脆弱。未来,当疫情真正引起关注时,零号病人的姓名和简历才会公之于众,她们的故事才会成为理解新现象的框架。垂直传播的 "零号病人 "将是女性,就像寨卡病毒一样。妇女需要实时了解科学的不确定性,而且,在同一人群遭遇两次健康突发事件后,决策者本应做好更充分的准备,将零散的知识转化为普遍的交流。从道德角度讲,人们有权了解现有的最佳科学,因为他们有责任对这些群体负责--普通人不理解科学的不确定性这一论点已不再令人信服。
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引用次数: 0
The Letter to the Editor as a tool to promote critical thinking in Latin American bioethics pedagogy 致编辑的信是促进拉丁美洲生物伦理学教学中批判性思维的工具。
IF 0.9 3区 哲学 Q3 ETHICS Pub Date : 2024-08-22 DOI: 10.1111/dewb.12462
Timothy Daly PhD
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引用次数: 0
Personhood: An emergent view from Africa and the West. 人格:来自非洲和西方的新观点。
IF 0.9 3区 哲学 Q3 ETHICS Pub Date : 2024-08-22 DOI: 10.1111/dewb.12461
Nancy S Jecker, Caesar A Atuire

African understandings of personhood are complex, with different accounts emphasizing distinct aspects of what it means to be a person. Some accounts stress excellence of character and performing well in social roles and relationships, while others focus on innate moral qualities of individuals independent of their conduct and character. This paper sheds new light on these twin aspects of personhood. It proposes a way to navigate these dual features by bringing African and Western personhood into conversation, building on the strengths of each approach, and developing a new view of personhood that we call, Emergent Personhood. Section 1 introduces diverse approaches to personhood within African thought. Section 2 compares African and Western approaches. Section 3 evaluates advantages and disadvantages of each and identifies conditions that any account of personhood must meet to leverage the advantages and avoid the disadvantages identified. Section 4 introduces Emergent Personhood, which meets these conditions. Section 5 concludes that expanding the conversation about personhood across cultures enriches an ongoing conversation about what it means to be a person.

非洲人对 "人 "的理解是复杂的,不同的说法强调 "人 "的不同含义。有些观点强调卓越的品格以及在社会角色和人际关系中的良好表现,而另一些观点则侧重于个人与生俱来的道德品质,与其行为和品格无关。本文对人格的这两个方面进行了新的阐释。本文提出了一种方法,通过将非洲人格和西方人格引入对话,借鉴每种方法的长处,发展出一种新的人格观,我们称之为 "新兴人格",从而驾驭这些双重特征。第 1 节介绍了非洲思想中关于人格的各种方法。第 2 节比较了非洲和西方的方法。第 3 节评估了每种方法的优缺点,并确定了任何关于人格的论述都必须满足的条件,以充分利用所确定的优势,避免所确定的劣势。第 4 节介绍了符合这些条件的新兴人格。第 5 节的结论是,扩展关于跨文化人格的对话可以丰富目前关于 "作为人意味着什么 "的对话。
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引用次数: 0
Factors associated with Saudi physicians' utilization of clinical ethics consultation services. 沙特医生利用临床伦理咨询服务的相关因素。
IF 0.9 3区 哲学 Q3 ETHICS Pub Date : 2024-07-15 DOI: 10.1111/dewb.12459
Ruaim A Muaygil, Raaoum M Jabor, Rahaf A Alrayes, Ghada S Alharbi, Shaima A Alqoud, Manar A Alenazi, Ftoon A Alenazi, Taim A Muayqil

Clinical Ethics Consultation (CEC) aims to resolve ethical dilemmas at the bedside. Through a structured process, CEC allows practitioners and patients to consult ethicists at times of moral conflict or uncertainty. Over the past few decades, CEC has become an invaluable part of healthcare practice. In Saudi Arabia, however, CEC services remain inexplicably underutilized. This study attempts to understand the factors associated with Saudi physicians' utilization of CEC to better meet the needs of practitioners and patients. Results indicate that although physicians routinely experience moral dilemmas, they seldom request a CEC. This is not due to unfamiliarity, lack of accessibility, or suspicion of ethical expertise. Rather, reluctance is likely due to an ingrained medical cultural stronghold that pressures practitioners to act heroically, and to resolve ethical dilemmas independently. Recommendations to improve the utilization of CEC services include wider availability, active collaborations with clinical practitioners, routine quality improvements, and managerial and national support.

临床伦理咨询(CEC)旨在解决床边的伦理难题。通过结构化流程,CEC 允许从业人员和患者在道德冲突或不确定时向伦理学家咨询。在过去的几十年里,CEC 已成为医疗实践中不可或缺的一部分。然而,在沙特阿拉伯,CEC 服务的利用率仍然低得令人费解。本研究试图了解与沙特医生利用 CEC 相关的因素,以更好地满足从业人员和患者的需求。研究结果表明,虽然医生经常会遇到道德困境,但他们很少会请求 CEC。这并不是因为不熟悉、缺乏可及性或对道德专业知识的怀疑。相反,不情愿的原因可能是根深蒂固的医学文化堡垒迫使从业人员逞英雄,独立解决道德困境。提高 CEC 服务利用率的建议包括:更广泛地提供 CEC 服务、与临床从业人员积极合作、例行质量改进以及管理和国家支持。
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引用次数: 0
Modifications to consent documentation with adults with communication disorders following brain injury: An exploratory study. 修改脑损伤后有交流障碍的成人的同意文件:一项探索性研究。
IF 0.9 3区 哲学 Q3 ETHICS Pub Date : 2024-07-14 DOI: 10.1111/dewb.12458
Jennifer Watermeyer, Chiara Aylward

Consent documentation for research studies is often inaccessible to people with neurogenic communication disorders following brain injury and there is limited literature on specific modifications for informed consent. This exploratory study aimed to identify effective strategies and modifications to consent processes for adults with brain injury. Using a fictitious research study, we developed a set of Participant Information Sheets (PISs) varying in complexity, presentation format, and communication modality. Evaluations were conducted with eight participants. Findings indicated diverse participant preferences for PIS modifications, suggesting simplified vocabulary, reduced text, carefully selected images, and an interactive presentation modality as helpful strategies. Building on previous literature, we present refined guidelines for consent modifications for adults with neurogenic communication disorder after brain injury. These guidelines can promote more appropriate inclusion of communicatively impaired populations in research and assist ethics committees and researchers in preparing modified consent documents.

脑损伤后有神经源性交流障碍的人通常无法获得研究项目的同意文件,而关于知情同意的具体修改方法的文献也很有限。这项探索性研究旨在确定针对脑损伤成人的同意程序的有效策略和修改方法。通过一项虚构的研究,我们开发了一套参与者信息表 (PIS),其复杂程度、展示形式和交流方式各不相同。我们对八名参与者进行了评估。评估结果表明,不同的参与者对 PIS 的修改有不同的偏好,建议将简化词汇、减少文字、精心挑选的图片和互动演示模式作为有用的策略。在以往文献的基础上,我们提出了针对脑损伤后神经源性交流障碍成人的同意书修改指南。这些指南可以促进将有交流障碍的人群更适当地纳入研究,并帮助伦理委员会和研究人员准备修改后的同意书文件。
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引用次数: 0
Analysis of the legal situation regarding euthanasia in Ecuador, Colombia, and Peru: Towards a Latin American model of medical assistance in dying? 分析厄瓜多尔、哥伦比亚和秘鲁有关安乐死的法律状况:建立拉丁美洲临终医疗救助模式?
IF 0.9 3区 哲学 Q3 ETHICS Pub Date : 2024-07-12 DOI: 10.1111/dewb.12457
Luis Espericueta

Colombia was one of the first countries to decriminalise euthanasia. However, what is known in the international academic literature about the country's regulations is scarce and outdated. Such lack of information on the situation in Latin America is even more evident in the case of Peru, where the Lima Superior Court of Justice set a precedent by allowing a person to have access to euthanasia in 2021. Ecuador, which has just decriminalised euthanasia for all its citizens in February 2024, risks being similarly absent from the international dialogue. This article summarises for the first time all the regulations in force regarding euthanasia in Latin America, through a study of primary sources in Spanish, and analyses some of the convergences between these three neighbouring countries.

哥伦比亚是最早将安乐死非刑罪化的国家之一。然而,国际学术文献中有关该国法规的内容很少,而且已经过时。秘鲁利马高等法院开创了先例,允许在 2021 年实施安乐死。厄瓜多尔刚刚于 2024 年 2 月将安乐死合法化,其所有公民都有可能同样无法参与国际对话。本文通过对西班牙文原始资料的研究,首次总结了拉丁美洲关于安乐死的所有现行法规,并分析了这三个邻国之间的一些共同点。
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引用次数: 0
Benefit-sharing with human participants in health research in South Africa: A call for clarity. 在南非的健康研究中与人类参与者分享利益:呼吁澄清。
IF 2.2 3区 哲学 Q3 ETHICS Pub Date : 2024-05-29 DOI: 10.1111/dewb.12456
Claude Kamau, Larisse Prinsen, Donrich Thaldar

This study critically examines the concept of benefit-sharing in the context of health research involving human participants in South Africa, identifying a significant gap in the precision and application of terminology. It introduces a new terminological framework designed to provide clarity and facilitate standardisation in both national and international discourse on benefit-sharing. The analysis extends to the complex legal landscape in South Africa, highlighting the nuances of mandated, permitted, and prohibited practices of benefit-sharing across various statutes. This reveals substantial implications for ethics committees, researchers, and participants, emphasising the need for a legal and ethical recalibration. Furthermore, the manuscript critiques South Africa's main ethics instruments for their inadequate guidance on benefit-sharing and proposes recommendations for enhancing the Department of Health's ethics guidelines. By advocating for a coherent, legally informed approach to ethical decision-making, the study underscores the need for integrating the proposed framework and legal insights into ethics guidelines. This comprehensive strategy aims not only to advance ethical practices within South Africa but also to contribute significantly to the global discourse on benefit-sharing in health research.

本研究对南非涉及人类参与者的健康研究中的 "利益共享 "概念进行了批判性研究,发现在术语的准确性和应用方面存在重大差距。它引入了一个新的术语框架,旨在为国内和国际上有关利益分享的讨论提供清晰度并促进标准化。分析扩展到南非复杂的法律环境,强调了各种法规中规定的、允许的和禁止的利益分享做法的细微差别。这揭示了对伦理委员会、研究人员和参与者的重大影响,强调了重新调整法律和伦理的必要性。此外,该手稿还批评了南非的主要伦理文书对利益分享的指导不足,并提出了加强卫生部伦理指南的建议。本研究倡导以连贯一致、有法律依据的方式进行伦理决策,强调有必要将建议的框架和法律见解纳入伦理指南。这项综合战略不仅旨在推动南非国内的伦理实践,还将极大地促进关于健康研究中利益共享的全球讨论。
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引用次数: 0
The ethics of research informed consent from the Kyrgyz perspective: A qualitative study. 从吉尔吉斯斯坦的角度看研究知情同意的伦理问题:定性研究。
IF 2.2 3区 哲学 Q3 ETHICS Pub Date : 2024-05-14 DOI: 10.1111/dewb.12451
Tamara Kudaibergenova

To ensure informed consent is tailored to ethnic Asian communities, it is necessary to establish an ethical foundation that is relevant to the specific populations. We hypothesized that certain communitarian factors unique to traditional Kyrgyz culture may influence an individual's decision to participate in research. Guided by Seedhouse's (2005) Rational Field Theory, we conducted qualitative, in-depth interviews with cultural experts in Kyrgyzstan to identify the ethical foundations of decision-making for informed consent in Kyrgyz culture. The results indicate that Kyrgyz people have a distinctive decision-making style influenced by their nomadic culture and history, which values and prioritizes family integrity and reputation. These findings indicate that a multidimensional approach based on socio-cultural sensitivities is necessary to assess the appropriateness of consent procedures. We believe our results may have implications for revising the guidelines of local and regional research ethics committees in Kyrgyzstan and other Central Asian countries.

为了确保知情同意适合亚洲少数民族社区,有必要建立一个与特定人群相关的伦理基础。我们假设,吉尔吉斯传统文化中某些独特的社群因素可能会影响个人参与研究的决定。在 Seedhouse(2005 年)的理性场理论指导下,我们对吉尔吉斯斯坦的文化专家进行了深入的定性访谈,以确定吉尔吉斯文化中知情同意决策的伦理基础。结果表明,吉尔吉斯人受其游牧文化和历史的影响,具有独特的决策风格,重视并优先考虑家庭完整性和声誉。这些结果表明,有必要采用基于社会文化敏感性的多维方法来评估同意程序的适当性。我们相信,我们的研究结果可能会对吉尔吉斯斯坦和其他中亚国家修订当地和地区研究伦理委员会的指导方针产生影响。
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引用次数: 0
期刊
Developing World Bioethics
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