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Editorial - ethical practice and genomic research. 编辑-伦理实践和基因组研究。
Q1 Arts and Humanities Pub Date : 2020-12-09 DOI: 10.1080/11287462.2020.1855712
Janet Seeley, Michael Parker
Genomic research offers the potential of significant improvements in diagnosis, treatment, and in health care more broadly. The achievement of these benefits against a background of well-founded pu...
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引用次数: 1
Assessing training needs in health research ethics: a case study from the University of Zambia School of Medicine. 评估卫生研究伦理方面的培训需求:来自赞比亚大学医学院的案例研究。
Q1 Arts and Humanities Pub Date : 2020-12-02 DOI: 10.1080/11287462.2020.1853001
Gershom Chongwe, Bornwell Sikateyo, Linda Kampata, Joseph Ali, Kristina Hallez, Adnan A Hyder, Nancy Kass, Charles Michelo

In many settings, and perhaps especially in low-middle income countries, training institutions do not adequately prepare their students for the ethical challenges that confront them in professional life. We conducted a survey to assess the training needs in research ethics among the faculty at the University of Zambia, School of Medicine (UNZASoM) using a structured questionnaire distributed to faculty members in January 2015. The study was approved by the University of Zambia Biomedical Research Ethics Committee. Seventy-five faculty members of various ranks completed the questionnaire. It was found that 31% of the faculty had not received any research ethics training. Of those who had received training, most of them had received it through short workshops of five days or less (57.4%, n = 31), while only 27.7% received ethics training as a component of an academic degree and 22.2% obtained it through electronic web-based courses. While most faculty (70.7%) reported being well-prepared to guide their students in developing a research methods section of a research protocol, only 25.3% felt they were well-prepared to guide on ethical considerations. This study has demonstrated gaps in research ethics training among faculty members at UNZASoM. Mandatory instruction in research ethics among faculty and students is recommended.

在许多情况下,尤其是在中低收入国家,培训机构并没有为学生在职业生涯中面临的道德挑战做好充分的准备。我们在2015年1月对赞比亚大学医学院(UNZASoM)的教师进行了一项调查,以评估他们在研究伦理方面的培训需求。这项研究得到了赞比亚大学生物医学研究伦理委员会的批准。75名不同级别的教师完成了问卷调查。调查发现,31%的教师没有接受过任何研究伦理培训。在接受过培训的人中,大多数是通过五天或更短的短期讲习班接受培训的(57.4%,n = 31),而只有27.7%的人将道德培训作为学位的组成部分,22.2%的人通过电子网络课程获得道德培训。虽然大多数教师(70.7%)报告说他们准备好了指导学生制定研究方案的研究方法部分,但只有25.3%的人认为他们准备好了指导道德考虑。这项研究表明,联扎索特派团教员在研究伦理培训方面存在差距。建议对教师和学生进行强制性的研究伦理指导。
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引用次数: 1
Global responsibility vs. individual dreams: addressing ethical dilemmas created by the migration of healthcare practitioners. 全球责任与个人梦想:解决医疗从业者迁移造成的伦理困境。
Q1 Arts and Humanities Pub Date : 2020-06-16 DOI: 10.1080/11287462.2020.1773054
Fahmida Hossain

Background The migration of health care professionals from developing to developed countries is a trend. This migration benefits the destination countries but is quite often devastating to healthcare systems within the home countries. Skilled practitioners from developing countries forego opportunities in their homelands to migrate to developed countries. This leaves a vacuum of talent, weakening the health systems in the 'home' countries. Methods This piece analyzes the consequence of such migration through the lens of the four principles of Universal Declaration of Bioethics and Human rights (UDBHR): equality, justice and equity, solidarity and cooperation, and sharing of benefits. Results In the light of moral imagination and moral reflection, we can understand one another as global citizens. Policymakers must develop guides to restore balance and ensure equitable healthcare worldwide. Incorporating ethics education in medical schools and hospitals, implementing temporary migration visas, and helping home countries offer attractive compensation can address this concern. Conclusions Health is a universal human right; the well-being of all must be addressed without overly limiting the rights of practitioners to build the lives they imagine. On the other hand, practitioners should consider themselves global citizens and consider their ethical obligations when considering their migration.

卫生保健专业人员从发展中国家向发达国家迁移是一种趋势。这种移徙使目的国受益,但往往对原籍国的卫生保健系统造成毁灭性影响。发展中国家的熟练从业人员放弃在本国的机会,移民到发达国家。这造成了人才真空,削弱了“母国”的卫生系统。本文从《世界生命伦理与人权宣言》(UDBHR)的四项原则(平等、正义与公平、团结与合作、利益共享)的角度分析了这种迁移的后果。结果:在道德想象和道德反思的光照下,我们可以作为世界公民相互理解。决策者必须制定指南,以恢复平衡并确保全世界的公平医疗保健。将道德教育纳入医学院和医院,实施临时移民签证,并帮助原籍国提供有吸引力的补偿,可以解决这一问题。健康是一项普遍人权;所有人的福祉必须得到解决,而不过度限制从业人员建立他们想象的生活的权利。另一方面,从业者应该将自己视为全球公民,并在考虑他们的移民时考虑他们的道德义务。
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引用次数: 2
"Are we getting the biometric bioethics right?" - the use of biometrics within the healthcare system in Malawi. “我们的生物识别技术是否符合生物伦理?”-在马拉维的医疗保健系统中使用生物识别技术。
Q1 Arts and Humanities Pub Date : 2020-06-05 DOI: 10.1080/11287462.2020.1773063
Mphatso Mwapasa, Kate Gooding, Moses Kumwenda, Marriott Nliwasa, Kruger Kaswaswa, Rodrick Sambakunsi, Michael Parker, Susan Bull, Nicola Desmond

Biometrics is the science of establishing the identity of an individual based on their physical attributes. Ethical concerns surrounding the appropriate use of biometrics have been raised, especially in resource-poor settings. A qualitative investigation was conducted to explore biometrics clients (n = 14), implementers (n = 12) and policy makers as well as bioethicists (n = 4) perceptions of the ethical aspects of implementing biometrics within the healthcare system in Malawi. Informed use, privacy and confidentiality as well as perceptions of benefits and harms were identified as major issues in the application of biometrics. Implementation of biometrics within the healthcare system in Malawi poses a range of potential ethical issues and practical challenges that impact on equitable uptake. There is a need for more research to explore the benefits and harms of biometrics in practice. Improved community engagement and sensitization should be a required component of biometrics introduction in Malawi.

生物计量学是一门根据个人的身体特征来确定其身份的科学。人们提出了关于适当使用生物识别技术的伦理问题,特别是在资源贫乏的环境中。进行了一项定性调查,以探讨生物识别客户(n = 14),实施者(n = 12)和政策制定者以及生物伦理学家(n = 4)对马拉维医疗保健系统内实施生物识别技术的伦理方面的看法。知情使用、隐私和保密以及对利益和危害的认识被确定为生物识别技术应用中的主要问题。生物识别技术在马拉维医疗保健系统的实施带来了一系列潜在的伦理问题和实际挑战,影响了公平的吸收。有必要进行更多的研究来探索生物识别技术在实践中的利弊。改善社区参与和宣传应成为马拉维引入生物识别技术的必要组成部分。
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引用次数: 2
HIV prevention clinical trials' community engagement guidelines: inequality, and ethical conflicts. 艾滋病预防临床试验的社区参与指南:不平等和伦理冲突。
Q1 Arts and Humanities Pub Date : 2020-06-05 DOI: 10.1080/11287462.2020.1773061
Morenike O Folayan, Kristin Peterson

In 2004 and 2005, the first clinical trials were launched to investigate the use of tenofovir for HIV prevention in Cambodia,Cameroon, Nigeria and Thailand. Controversies erupted over the ethical integrity of the research protocol. We reflect on the events that ledto the controversies and identified that scientific and ethical concerns raised by members of local communities at each of these sites wereerased by trialists, causing crisis that led to premature shut down the early PrEP trials. In the aftermath of these trials, the World HealthOrganisation, UNAIDS, and AVAC developed ethics guidelines intended to recognize the concerns as authentic, and developed guidelines toimprove researchers' engagement of communities in biomedical HIV prevention trial design and implementation. Our findings suggest thatthe ethics guidelines are limited in its ability to address power inequalities that leads to voice erasures and non-recognition of localcompetencies. Rather the ethical documents enabled trialists to gain a new sense of authority through the interpretations of ethical researchconduct enabling trialists regain power that can further entrench inequality and voice erasures. To address concerns with what seems anintractable problem, we suggested models of engagement for off-shored research may be the option.

2004年和2005年,在柬埔寨、喀麦隆、尼日利亚和泰国开展了第一批临床试验,以调查替诺福韦用于艾滋病毒预防的使用情况。研究方案的伦理完整性引发了争议。我们反思了导致争议的事件,并发现这些地点的当地社区成员提出的科学和伦理问题被试验人员消除了,造成了导致早期PrEP试验过早关闭的危机。在这些试验之后,世界卫生组织、联合国艾滋病规划署和AVAC制定了伦理准则,旨在承认这些担忧是真实的,并制定了准则,以提高研究人员在社区中参与艾滋病毒生物医学预防试验的设计和实施。我们的研究结果表明,道德准则在解决权力不平等问题上的能力有限,权力不平等导致了声音的抹去和对地方能力的不承认。相反,伦理文件使审判者通过对伦理研究行为的解释获得了一种新的权威感,使审判者重新获得权力,从而进一步巩固不平等和消除声音。为了解决这个看似棘手的问题,我们建议离岸研究的参与模式可能是一个选择。
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引用次数: 5
When can Muslims withdraw or withhold life support? A narrative review of Islamic juridical rulings. 穆斯林何时可以撤销或停止生命支持?伊斯兰司法裁决的叙述性回顾。
Q1 Arts and Humanities Pub Date : 2020-03-22 eCollection Date: 2020-01-01 DOI: 10.1080/11287462.2020.1736243
Afshan Mohiuddin, Mehrunisha Suleman, Shoaib Rasheed, Aasim I Padela

When it is ethically justifiable to stop medical treatment? For many Muslim patients, families, and clinicians this ethical question remains a challenging one as Islamic ethico-legal guidance on such matters remains scattered and difficult to interpret. In light of this gap, we conducted a systematic literature review to aggregate rulings from Islamic jurists and juridical councils on whether, and when, it is permitted to withdraw and/or withhold life-sustaining care. A total of 16 fatwās were found, 8 of which were single-author rulings, and 8 represented the collective view of a juridical council. The fatwās are similar in that nearly all judge that Islamic law, provided certain conditions are met, permits abstaining from life-sustaining treatment. Notably, the justifying conditions appear to rely on physician assessment of the clinical prognosis. The fatwās differ when it comes to what conditions justify withdrawing or withholding life- sustaining care. Our analyses suggest that while notions of futility greatly impact the bioethical discourse regarding with holding and/or withdrawal of treatment, the conceptualization of futility lacks nuance. Therefore, clinicians, Islamic jurists, and bioethicists need to come together in order to unify a conception of medical futility and relate it to the ethics of withholding and/or withdrawal of treatment.

何时停止治疗在伦理上是合理的?对于许多穆斯林患者、家属和临床医生来说,这个伦理问题仍然是一个具有挑战性的问题,因为伊斯兰教在此类问题上的伦理-法律指导仍然分散且难以解释。有鉴于此,我们进行了一次系统的文献综述,以汇总伊斯兰法学家和司法委员会关于是否允许以及何时允许撤销和/或暂停维持生命的治疗的裁决。共找到 16 篇法特瓦(fatwās),其中 8 篇为单一作者的裁决,8 篇代表了一个司法委员会的集体观点。这些法特瓦的内容大同小异,几乎所有的法特瓦都认为,只要满足某些条件,伊斯兰法允许放弃维持生命的治疗。值得注意的是,这些条件似乎都依赖于医生对临床预后的评估。法特瓦在哪些条件下可以撤销或停止维持生命的治疗方面存在分歧。我们的分析表明,虽然 "无效 "的概念在很大程度上影响了有关保留和/或撤销治疗的生命伦理讨论,但 "无效 "的概念缺乏细微差别。因此,临床医生、伊斯兰法学家和生命伦理学者需要走到一起,以统一医疗无效的概念,并将其与暂停和/或撤销治疗的伦理学联系起来。
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引用次数: 0
Informed consent in genomic research and biobanking: taking feedback of findings seriously. 基因组研究和生物银行中的知情同意:认真对待研究结果的反馈。
Q1 Arts and Humanities Pub Date : 2020-02-23 DOI: 10.1080/11287462.2020.1717896
Paulina Tindana, Cornelius Depuur, Jantina de Vries, Janet Seeley, Michael Parker

Genomic research and biobanking present several ethical, social and cultural challenges, particularly when conducted in settings with limited scientific research capacity. One of these challenges is determining the model of consent that should support the sharing of human biological samples and data in the context of international collaborative research. In this paper, we report on the views of key research stakeholders in Ghana on what should count as good ethical practice when seeking consent for genomic research and biobanking in Africa. This study was part of a multi-country qualitative case study conducted in three African countries: Ghana, Uganda and Zambia under the auspices of the Human Heredity and Health in Africa initiative (H3Africa). Our study suggests that while participants are willing to give consent for their samples and associated data to be used for future research purposes, they expect to receive feedback about the progress of the research and about the kinds of research being undertaken on their samples and data. These expectations need to be anticipated and discussed during the consent process which should be seen as part of an ongoing communication process throughout the research process.

基因组研究和生物银行提出了若干伦理、社会和文化挑战,特别是在科研能力有限的环境中进行时。其中一项挑战是确定在国际合作研究背景下支持共享人类生物样本和数据的同意模式。在本文中,我们报告了加纳主要研究利益相关者的观点,即在寻求非洲基因组研究和生物银行的同意时,什么应该算作良好的伦理实践。这项研究是在非洲人类遗传和健康倡议(H3Africa)主持下在加纳、乌干达和赞比亚这三个非洲国家进行的多国定性案例研究的一部分。我们的研究表明,虽然参与者愿意同意将他们的样本和相关数据用于未来的研究目的,但他们希望收到有关研究进展的反馈,以及正在对他们的样本和数据进行的研究类型。这些期望需要在同意过程中进行预期和讨论,这应被视为整个研究过程中持续沟通过程的一部分。
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引用次数: 13
Ethics and etiquette in an emergency vaccine trial. The orchestration of compliance. 紧急疫苗试验中的道德与礼仪遵从性的编排。
Q1 Arts and Humanities Pub Date : 2020-02-21 eCollection Date: 2020-01-01 DOI: 10.1080/11287462.2020.1726591
Arsenii Alenichev

Participant non-compliance and withdrawal from randomized clinical trials has increased focus on analysing the results from the "per-protocol" population that complies with a trial's protocols. There is no clear understanding of what shapes protocol compliance in practice. In this paper, I theorize clinical research from the perspective of participants in an Ebola vaccine trial by analysing the practices that contributed to very high compliance rates. In this setting, per-protocol compliance became an essential component in forming a class of "proper" researchers and participants working together in the rapidly expanding market of clinical research. Bioethics supports participants' right to withdraw from research as an ethical safeguard in the process. But participants seeking affiliations with powerful institutions may voluntarily embrace their trial responsibilities over a right to withdraw. To understand this phenomenon, this analysis uses the notion of bioetiquette - the set of rules specifying "proper" and "improper" trial subjects and behaviours - which runs in the shadow of formal bioethics in trials and requires careful transdisciplinary examination.

参与者不遵守随机临床试验和退出随机临床试验增加了人们对分析符合试验方案的“每个方案”人群结果的关注。对于在实践中是什么形成了协议遵从性,目前还没有明确的理解。在本文中,我从埃博拉疫苗试验参与者的角度对临床研究进行了理论化,分析了导致高依从率的做法。在这种情况下,在快速扩大的临床研究市场中,每个方案的依从性成为形成一类“适当的”研究人员和参与者共同工作的重要组成部分。生物伦理学支持参与者退出研究的权利,作为研究过程中的伦理保障。但寻求与强大机构建立联系的参与者可能会自愿接受他们的审判责任,而不是退出的权利。为了理解这一现象,该分析使用了生物礼仪的概念——一套规定“适当的”和“不适当的”试验对象和行为的规则——它在试验的正式生物伦理学的阴影下运行,需要仔细的跨学科检查。
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引用次数: 2
Community engagement and ethical global health research. 社区参与和伦理全球卫生研究。
Q1 Arts and Humanities Pub Date : 2019-12-20 eCollection Date: 2020-01-01 DOI: 10.1080/11287462.2019.1703504
Bipin Adhikari, Christopher Pell, Phaik Yeong Cheah

Community engagement is increasingly recognized as a critical element of medical research, recommended by ethicists, required by research funders and advocated in ethics guidelines. The benefits of community engagement are often stressed in instrumental terms, particularly with regard to promoting recruitment and retention in studies. Less emphasis has been placed on the value of community engagement with regard to ethical good practice, with goals often implied rather than clearly articulated. This article outlines explicitly how community engagement can contribute to ethical global health research by complementing existing established requirements such as informed consent and independent ethics review. The overarching and interlinked areas are (1) respecting individuals, communities and stakeholders; (2) building trust and social relationships; (3) determining appropriate benefits; minimizing risks, burdens and exploitation; (4) supporting the consent process; (5) understanding vulnerabilities and researcher obligations; (6) gaining permissions, approvals and building legitimacy and (7) achieving recruitment and retention targets.

社区参与日益被认为是医学研究的一个关键因素,这是伦理学家建议的,是研究资助者的要求,也是伦理准则所提倡的。社区参与的好处往往以工具性的方式强调,特别是在促进研究的征聘和留用方面。在道德良好做法方面,社区参与的价值受到的重视较少,目标往往是隐含的,而不是明确表达的。本文明确概述了社区参与如何通过补充知情同意和独立伦理审查等现有既定要求来促进全球卫生伦理研究。首要和相互关联的领域是:(1)尊重个人、社区和利益相关者;(2)建立信任和社会关系;(三)确定适当的利益;尽量减少风险、负担和剥削;(4)支持同意程序;(5)了解漏洞和研究人员的义务;(6)获得许可、批准和建立合法性;(7)实现招聘和保留目标。
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引用次数: 72
Health assessment and the capability approach. 健康评估和能力方法
Q1 Arts and Humanities Pub Date : 2019-09-30 eCollection Date: 2019-01-01 DOI: 10.1080/11287462.2019.1673028
Rodrigo López Barreda, Joelle Robertson-Preidler, Paula Bedregal García

Health has an important role in the achievement of a good quality of life. Many public policies intended to enhance individual and population health. Amartya Sen's Capability Approach (CA) offers a framework to assess well-being, as well as interventions seeking to increase it. There are, however, important practical challenges that must be faced before applying CA to concrete situations, such as health. One of these challenges is defining whether it is functioning or a capability that is the feature to be assessed. Moreover, some aspects of freedom that are relevant for CA are frequently neglected, such as agency. These aspects must be considered when performing a health assessment using the CA as a framework. A health assessment using the CA as a framework should include indicators based on the achieved dimension (health functioning), resources and conversion factors (health capability), and freedom to achieve (agency).

摘要健康在实现良好生活质量方面发挥着重要作用。许多旨在加强个人和人口健康的公共政策。Amartya Sen的能力方法(CA)提供了一个评估幸福感的框架,以及旨在提高幸福感的干预措施。然而,在将CA应用于健康等具体情况之前,必须面临一些重要的实际挑战。其中一个挑战是确定它是在发挥作用,还是作为要评估的特征的能力。此外,与CA相关的自由的某些方面经常被忽视,例如代理。在使用CA作为框架进行健康评估时,必须考虑这些方面。以CA为框架的健康评估应包括基于已实现维度(健康功能)、资源和转换因素(健康能力)以及实现自由度(机构)的指标。
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引用次数: 0
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Global Bioethics
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