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Protected from harm, harmed by protection: ethical consequences of the exclusion of pregnant participants from clinical trials 保护免受伤害,被保护伤害:将怀孕参与者排除在临床试验之外的伦理后果
IF 1.7 Q2 ETHICS Pub Date : 2023-07-25 DOI: 10.1177/17470161231189843
R. Zur
Pregnancy is a frequently applied exclusion criteria for many forms of research. Common justifications for this exclusion include the potential for teratogenicity, as well as the potential for physiologic changes in pregnancy to impact the research itself. The systematic exclusion of pregnant persons from clinical studies has created a significant gap in knowledge regarding medication safety and efficacy in pregnancy, which continues to cause significant harm to pregnant persons in need of medical therapy. To produce meaningful data and facilitate effective knowledge translation to the clinical setting, special consideration to the pharmacology of pregnancy, as well as to outcomes of concern for this population is essential. The exclusion of pregnant participants from research is not ethically justifiable, as it violates the principles of autonomy, justice and nonmaleficence. While the inclusion of pregnant patients in research presents it’s own challenges, with appropriate methodological, ethical, and clinical considerations, we may be able to narrow the knowledge gap and improve drug availability and safety for pregnant patients and their children.
怀孕是许多研究中经常使用的排除标准。这种排除的常见理由包括潜在的致畸性,以及怀孕期间的生理变化可能影响研究本身。系统地将孕妇排除在临床研究之外,造成了妊娠期药物安全性和有效性知识的重大空白,继续对需要药物治疗的孕妇造成重大伤害。为了产生有意义的数据和促进有效的知识转化到临床设置,特别考虑怀孕的药理学,以及对这一人群的关注结果是必不可少的。将怀孕参与者排除在研究之外在伦理上是不合理的,因为它违反了自主、公正和无害的原则。虽然将怀孕患者纳入研究本身就存在挑战,但通过适当的方法、伦理和临床考虑,我们可能能够缩小知识差距,提高怀孕患者及其子女的药物可用性和安全性。
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引用次数: 0
Who reviews what you do at the zoo? Considerations for research ethics with captive exotic animals 谁评论你在动物园做的事?对圈养外来动物研究伦理的考虑
IF 1.7 Q2 ETHICS Pub Date : 2023-07-25 DOI: 10.1177/17470161231188615
E. Fernandez, Todd J. McWhorter
Research in zoos is an important scientific endeavor that requires several complex considerations in order to occur. Among those many considerations are the ethics involved in conducting zoo research. However, it is not always clear how zoo researchers should go about resolving any research ethics matters, even determining when some type of research ethics committee should be involved in those deliberations. Our paper attempts to provide some resolutions for these issues, namely in three sections: (1) a brief history of human and animal research ethics, (2) general guidelines for zoo research ethics applications, and (3) theoretical, ethical dilemmas at the zoo. In each section, we consider pragmatic attempts to resolve any issues, as well as provide examples to illustrate our points. The primary focus of the paper is to facilitate consideration of the wide array of ethical factors any zoo researcher might encounter, as well as provide a basic set of ethical guidelines for zoo research. We also emphasize the importance of the welfare of the animals for all zoo research projects.
动物园里的研究是一项重要的科学努力,需要考虑几个复杂的因素才能进行。在众多考虑中,进行动物园研究涉及的伦理问题是其中之一。然而,人们并不总是清楚动物园的研究人员应该如何解决任何研究伦理问题,甚至不知道什么时候应该由某种研究伦理委员会参与这些审议。本文试图从三个方面为这些问题提供一些解决方案:(1)人类和动物研究伦理的简史;(2)动物园研究伦理应用的一般准则;(3)动物园的理论和伦理困境。在每个部分中,我们考虑解决任何问题的实用尝试,并提供示例来说明我们的观点。本文的主要重点是促进对任何动物园研究人员可能遇到的各种伦理因素的考虑,并为动物园研究提供一套基本的伦理准则。我们也强调动物福利对所有动物园研究项目的重要性。
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引用次数: 1
Reconceptualizing participant vulnerability in Scholarship of Teaching and Learning research: exploring the perspectives of health faculty students in Aotearoa New Zealand 重新定义教学和学习研究中的参与者脆弱性:探索新西兰奥特罗阿卫生学院学生的观点
IF 1.7 Q2 ETHICS Pub Date : 2023-07-25 DOI: 10.1177/17470161231188720
A. Lees, R. Godbold, S. Walters
While the need to protect vulnerable research participants is universal, conceptual challenges with the notion of vulnerability may result in the under or over-protection of participants. Ethics review bodies making assumptions about who is vulnerable and in what circumstance can be viewed as paternalistic if they do not consider participant viewpoints. Our study focuses on participant vulnerability in Scholarship of Teaching and Learning (SoTL) research. We aim to illuminate students’ views on participant vulnerability to contribute to critical analysis of the role and processes of ethics review. Additionally, we aim to highlight the importance of seeking the views of participant communities, especially in research environments beyond ethics review’s medical origins. Thirty-four students from a health-related faculty at a university in Aotearoa New Zealand, participated in five focus groups. Participants discussed factors affecting their potential participation in research drawing upon a series of vignettes based on examples of published SoTL projects. Themes, generated using reflexive thematic analysis, built a participant-informed picture of vulnerability. Findings indicate that students do not generally consider themselves vulnerable and instead consider participation in SoTL research through an agentic lens. Students expect that participation will be voluntary, not negatively impact their grades, and not single them out so that others could judge them. Our study also highlights the value students place on relationships with one another and teaching staff and the implications these have for SoTL research participation and future professional practice. This research challenges research ethics committees to think further about vulnerability in the context of SoTL whilst highlighting the importance of providing opportunities for research participants more broadly to explore and vocalize their views as members of participant communities.
虽然保护脆弱的研究参与者的需要是普遍的,但对脆弱性概念的概念性挑战可能导致对参与者的保护不足或过度。伦理审查机构如果不考虑参与者的观点,就会假设谁是弱势群体,在什么情况下会被视为家长式作风。本研究主要关注教与学学术研究中的参与者脆弱性。我们的目标是阐明学生对参与者脆弱性的看法,以有助于对伦理审查的作用和过程进行批判性分析。此外,我们的目标是强调寻求参与者群体意见的重要性,特别是在超越伦理审查医学起源的研究环境中。来自新西兰奥特罗阿一所大学健康系的34名学生参加了5个焦点小组。与会者根据一系列以已发表的SoTL项目为基础的例子,讨论了影响他们可能参与研究的因素。使用反身性主题分析生成的主题构建了参与者知情的脆弱性图景。研究结果表明,学生通常不认为自己是弱势群体,而是通过代理视角来考虑参与SoTL研究。学生们希望参与是自愿的,不会对他们的成绩产生负面影响,也不会把他们挑出来让别人评判他们。我们的研究还强调了学生对彼此关系和教师关系的重视,以及这些关系对SoTL研究参与和未来专业实践的影响。这项研究挑战了研究伦理委员会进一步思考SoTL背景下的脆弱性,同时强调了为研究参与者提供更广泛的机会来探索和表达他们作为参与者社区成员的观点的重要性。
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引用次数: 0
Shifting attitudes on animal ‘ownership’: Ethical implications for welfare research and practice terminology 对动物“所有权”态度的转变:福利研究和实践术语的伦理含义
IF 1.7 Q2 ETHICS Pub Date : 2023-07-11 DOI: 10.1177/17470161231186060
Julia Henning, Ana Goncalves Costa, E. Fernandez
The roles companion animals have played in our lives has dramatically changed over the last few decades. At the same time, the terms we use to describe both the people and animals in these human-animal relationships have also changed. One example includes the use of the terms ‘owner’ or ‘guardian’ to refer to the human caretaker. While preferences by society appear to indicate increased interest in referring to companion animal caretakers as ‘guardians’, others have cautioned against its use or attempted to restrict it. Additionally, the use of animal welfare terminology has direct implications for how we conduct both welfare research and practice. Our paper examines the use of ‘owner’ and ‘guardian’ with respect to (1) the implications for changing terminology on the function, clarity and uniformity of their use, and (2) the ethical and welfare impact that coincides with each term’s use. Our goal is to propose terminological considerations that could influence future welfare research, as well as help guide our interactions with companion animals.
在过去的几十年里,伴侣动物在我们生活中扮演的角色发生了巨大的变化。与此同时,我们用来描述人与动物之间关系的术语也发生了变化。一个例子包括使用术语“所有者”或“监护人”来指代人类看护人。虽然社会的偏好似乎表明,人们对将伴侣动物的看护人称为“监护人”越来越感兴趣,但也有人警告不要使用这种称呼,或试图限制这种称呼。此外,动物福利术语的使用对我们如何进行福利研究和实践有直接的影响。我们的论文从以下方面考察了“所有者”和“监护人”的使用:(1)改变术语对其使用的功能、清晰度和统一性的影响,以及(2)每个术语的使用对道德和福利的影响。我们的目标是提出可以影响未来福利研究的术语考虑,以及帮助指导我们与伴侣动物的互动。
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引用次数: 0
Ethical considerations and dilemmas for the researcher and for families in home-based research: A case for situated ethics 基于家庭的研究中研究者和家庭的伦理考虑和困境:一个情境伦理的案例
IF 1.7 Q2 ETHICS Pub Date : 2023-07-03 DOI: 10.1177/17470161231181860
I. Palaiologou, Alice V. Brown
When researching with or about families in home-based research, there are numerous unexpected ethical issues that can emerge, particularly in qualitative research. This paper is based on reflective accounts of four homed-based research projects, two in the UK and two Australia, which examined ethical dilemmas identified when engaged in home-based research with young children. Using a synergy of ecocultural theory and Foucauldian ideas of Heterotopia as theoretical conceptualisations, the authors employed reflective lenses to guide their approach, and examine dilemmas and complexities when conducting research in the home. We argue that, to address ethical dilemmas, researchers need to problematise and reflect upon the nature of respectful approaches and the ethical implications of their behaviours. We conclude that, although ethical codes are valuable when researching families at home, researchers should plan for and forefront their methodological approaches in ways that are family-centred, whilst also framed by practices that are ethical, respectful and reflective to the situated contexts of family’s ecologies and heterotopias.
在以家庭为基础的研究中,当与家庭一起或关于家庭进行研究时,会出现许多意想不到的伦理问题,特别是在定性研究中。本文基于对四个家庭研究项目的反思,其中两个在英国,两个在澳大利亚,这些项目研究了在与幼儿进行家庭研究时发现的伦理困境。利用生态文化理论和福柯的异托邦思想作为理论概念的协同作用,作者使用反射透镜来指导他们的方法,并在进行家庭研究时检查困境和复杂性。我们认为,为了解决伦理困境,研究人员需要对尊重方法的本质及其行为的伦理含义进行问题化和反思。我们的结论是,尽管伦理准则在家庭研究中是有价值的,但研究人员应该以家庭为中心的方式规划和前沿他们的方法方法,同时也要以伦理、尊重和反思家庭生态和异托邦的情境的实践为框架。
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引用次数: 0
Erratum to “Using wearable cameras to investigate health-related daily life experiences: A literature review of precautions and risks in empirical studies” “使用可穿戴相机调查与健康相关的日常生活体验:实证研究中的预防措施和风险的文献综述”的勘误
IF 1.7 Q2 ETHICS Pub Date : 2023-07-01 DOI: 10.1177/17470161231159486
Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). Erratum to “Using wearable cameras to investigate health-related daily life experiences: A literature review of precautions and risks in empirical studies”
知识共享非商业性CC BY-NC:本文在知识共享署名-非商业4.0许可(https://creativecommons.org/licenses/by-nc/4.0/)的条款下发布,该许可允许非商业用途,复制和分发作品,无需进一步许可,前提是原始作品的署名与SAGE和开放获取页面(https://us.sagepub.com/en-us/nam/open-access-at-sage)上指定的一致。“使用可穿戴相机调查与健康相关的日常生活体验:实证研究中的预防措施和风险的文献综述”的勘误
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引用次数: 0
Opinions and attitudes of research ethics committees in Arab countries in the Middle East and North African region toward ethical issues involving biobank research 中东北非地区阿拉伯国家研究伦理委员会对涉及生物样本库研究的伦理问题的看法和态度
IF 1.7 Q2 ETHICS Pub Date : 2023-06-29 DOI: 10.1177/17470161231185510
Zeinab Mohammed, F. Abdelgawad, M. Ahram, M. E. Ibrahim, A. Elgamri, Ehsan B. Gamel, L. Adarmouch, K. Rhazi, S. Abd ElHafeez, H. Silverman
Members of research ethics committees (RECs) face a number of ethical challenges when reviewing genomic research. These include issues regarding the content and type of consent, the return of individual research results, mechanisms of sharing specimens and health data, and appropriate community engagement efforts. This article presents the findings from a survey that sought to investigate the opinions and attitudes of REC members from four Arab countries in the Middle East and North Africa (Egypt, Morocco, Sudan, and Jordan) toward these ethical issues. Our findings suggest that efforts are required to better familiarize REC members with the requirements for ethical biobank research. Additionally, we recommend that further research is undertaken with REC members regarding the main items that should be present in the Material Transfer Agreements /Data Transfer Agreements in their corresponding countries and the type of consent that should be used in genomic research.
研究伦理委员会(rec)的成员在审查基因组研究时面临着许多伦理挑战。这些问题包括同意的内容和类型、归还个人研究成果、共享标本和卫生数据的机制以及适当的社区参与努力。本文介绍了一项调查的结果,该调查旨在调查来自中东和北非四个阿拉伯国家(埃及、摩洛哥、苏丹和约旦)的REC成员对这些伦理问题的意见和态度。我们的研究结果表明,需要努力使REC成员更好地熟悉伦理生物库研究的要求。此外,我们建议与REC成员就相应国家的材料转移协议/数据转移协议中应包含的主要项目以及基因组研究中应使用的同意类型进行进一步的研究。
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引用次数: 0
Agreement of farm animal behaviour and welfare studies with the ARRIVE Essential 10 农场动物行为和福利研究与抵达基本10的协议
IF 1.7 Q2 ETHICS Pub Date : 2023-06-29 DOI: 10.1177/17470161231183100
J. Calderón-Amor, Daniela Luna, T. Tadich
The inclusion of animals in research studies involves a great responsibility to ensure animal welfare within the relevant ethical and legal frameworks. This study aimed to review compliance with the ARRIVE Essential 10 requirements and the ethical oversight of animal behaviour and welfare studies in farm animals. Three journals and a total of 133 articles were reviewed for compliance with the ARRIVE Essential 10 items and criteria. Each article obtained a final score according to whether or not each criterion was met within each item. Likewise, ethical declaration in each article was recorded. Chi-square test and linear models were built to assess associations between the ethical statement presentation and the final ARRIVE Essential 10 score with the country, the species, and the journal. We found that 15% of the articles did not present an ethical statement. The journal with the highest impact factor and the countries of the Global South presented an ethical statement more frequently. Regarding the Essential 10, the item with the lowest agreement score was ‘Blinding’ and the one with the highest agreement was ‘Outcome Measures’. Also, significant differences were found between journals in terms of the Essential 10 score. Essential 10 provides relevant information that allows reviewers and readers to identify possible welfare risks and the validity of the results in animal welfare science publications.
将动物纳入研究涉及到在相关伦理和法律框架内确保动物福利的重大责任。本研究旨在审查对reach基本10项要求的遵守情况,以及对农场动物行为和福利研究的道德监督。三份期刊和总共133篇文章被审查是否符合ARRIVE基本的10项和标准。每篇文章根据是否满足每个项目中的每个标准获得最终分数。同样,记录每篇文章的伦理声明。建立了卡方检验和线性模型来评估伦理声明的呈现和最终的ARRIVE Essential 10评分与国家、物种和期刊之间的关系。我们发现15%的文章没有提供伦理声明。影响因子最高的期刊和全球南方国家更频繁地发表道德声明。在Essential 10中,一致性得分最低的是“Blinding”,一致性得分最高的是“Outcome Measures”。此外,不同期刊在Essential 10分方面也存在显著差异。Essential 10提供相关信息,使审稿人和读者能够识别动物福利科学出版物中可能存在的福利风险和结果的有效性。
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引用次数: 0
Ethical standards for research on marine mammals 海洋哺乳动物研究的伦理标准
IF 1.7 Q2 ETHICS Pub Date : 2023-06-22 DOI: 10.1177/17470161231182066
V. Papastavrou, C. Ryan
Conducting marine mammal research can raise several important ethical issues. For example, the continuation of whaling for commercial purposes despite the international moratorium provides opportunities for scientists to obtain data and tissue samples. In 2021 we analysed 35 peer-reviewed papers reporting research based on collaborations with Icelandic whalers. Results highlighted little consideration or understanding of the legal and ethical issues associated with the deliberate killing of whales amongst those researchers, funding bodies, universities and journals involved. Ethical statements were rarely provided. Those that were written were incomplete. Whilst research using whaling data may seem acceptable to some, it often becomes hard to justify when subject to scrutiny by the media and the public. Thus, there is a particular danger of reputational harm for early career researchers who may become unwittingly involved in such activities. Here we also consider the broader variety of ethical issues raised by non-lethal research (both historical and recent) on marine mammals including tagging and biopsy. We discuss instances where study animals were harmed or even killed and where the public mistook tags for harpoons. Without clear guidelines, reviewers and journal editors are put in an impossible position when considering whether to reject papers on ethical grounds. We propose that for such studies, universities, funders, journals, and permit issuers must require ethical assessments and that journals more effectively implement their existing policies on publishing ethical statements. The professional marine mammal societies need to work together to produce modern ethical guidance. Such guidance should require transparency in the provenance of data and samples while including advice on law, welfare issues, involvement of local scientists, and offshoring. Furthermore, it should require appraisal of and justification for the absolute necessity of invasive procedures. As is already the case in biomedical disciplines, ethical statements should be required in marine mammal science.
进行海洋哺乳动物研究可能会引发几个重要的伦理问题。例如,尽管国际禁止捕鲸,但出于商业目的的捕鲸仍在继续,这为科学家获取数据和组织样本提供了机会。2021年,我们分析了35篇同行评议的论文,这些论文报告了基于与冰岛捕鲸者合作的研究。研究结果表明,研究人员、资助机构、大学和期刊对与故意捕杀鲸鱼相关的法律和伦理问题缺乏考虑或理解。很少提供道德声明。所写的是不完整的。虽然使用捕鲸数据的研究似乎对某些人来说是可以接受的,但在受到媒体和公众的审查时,往往很难证明其合理性。因此,对于那些可能在不知不觉中卷入此类活动的早期职业研究人员来说,存在声誉受损的特别危险。在这里,我们还考虑了由海洋哺乳动物的非致命性研究(包括历史和最近的)引起的更广泛的伦理问题,包括标记和活检。我们讨论了研究动物受到伤害甚至被杀死的例子,以及公众将标签误认为鱼叉的例子。如果没有明确的指导方针,审稿人和期刊编辑在考虑是否以伦理理由拒绝论文时就会陷入两难境地。我们建议,对于此类研究,大学、资助者、期刊和许可证发行人必须要求进行伦理评估,并且期刊必须更有效地执行其发表伦理声明的现有政策。专业海洋哺乳动物协会需要共同努力,制定现代伦理指导。这种指导应要求数据和样本的来源具有透明度,同时包括关于法律、福利问题、当地科学家的参与和离岸外包的建议。此外,它应该要求评估和证明侵入性手术的绝对必要性。正如在生物医学学科中已经出现的情况一样,在海洋哺乳动物科学中应该要求伦理声明。
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引用次数: 1
Let’s do better: Improving research ethics knowledge, practice and systems of oversight 做得更好:完善科研伦理知识、实践和监管体系
IF 1.7 Q2 ETHICS Pub Date : 2023-06-22 DOI: 10.1177/17470161231183840
E. Dove, K. Chatfield
Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). Let’s do better: Improving research ethics knowledge, practice and systems of oversight
知识共享非商业性CC BY-NC:本文在知识共享署名-非商业4.0许可(https://creativecommons.org/licenses/by-nc/4.0/)的条款下发布,该许可允许非商业用途,复制和分发作品,无需进一步许可,前提是原始作品的署名与SAGE和开放获取页面(https://us.sagepub.com/en-us/nam/open-access-at-sage)上指定的一致。做得更好:完善科研伦理知识、实践和监管体系
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引用次数: 0
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Research Ethics
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