IRB

IRB
  • 文章类型: Journal Article
    常见的多基因风险评分(PRS)研究,遗传复杂的慢性病旨在改善与健康相关的预测,量身定制降低风险的干预措施,改善健康结果。然而,在临床环境中研究和使用PRS提高了公平性,临床,以及监管挑战,对于历史上被边缘化的种族,民族,和其他少数民族社区。作为国家人类基因组研究所资助的电子病历和基因组学IV网络的一部分,我们与患者/社区成员进行了在线焦点小组,临床医生,和机构审查委员会成员探讨他们对关键问题的看法,包括PRS研究,返回PRS结果,临床翻译,以及响应PRS结果的健康行为变化的障碍和促进者。跨利益相关者群体,我们的研究结果表明支持PRS的开发,并且对将PRS结果返回给研究参与者有浓厚兴趣.然而,我们还发现了多层次的障碍和利益相关者对成功实施所需要和可能的观点的显著差异。这些包括研究人员-参与者互动格式,健康和基因组素养,和一系列结构性障碍,比如金融不稳定,保险范围,以及在较贫穷的社区缺乏健康支持的基础设施和负担得起的健康食品选择。我们的发现强调了在PRS研究中重新审视和实施措施的必要性(例如,后续护理的激励措施和资源),以及促进基因组研究和健康结果公平的系统级政策。
    Research on polygenic risk scores (PRSs) for common, genetically complex chronic diseases aims to improve health-related predictions, tailor risk-reducing interventions, and improve health outcomes. Yet, the study and use of PRSs in clinical settings raise equity, clinical, and regulatory challenges that can be greater for individuals from historically marginalized racial, ethnic, and other minoritized communities. As part of the National Human Genome Research Institute-funded Electronic Medical Records and Genomics IV Network, we conducted online focus groups with patients/community members, clinicians, and members of institutional review boards to explore their views on key issues, including PRS research, return of PRS results, clinical translation, and barriers and facilitators to health behavioral changes in response to PRS results. Across stakeholder groups, our findings indicate support for PRS development and a strong interest in having PRS results returned to research participants. However, we also found multi-level barriers and significant differences in stakeholders\' views about what is needed and possible for successful implementation. These include researcher-participant interaction formats, health and genomic literacy, and a range of structural barriers, such as financial instability, insurance coverage, and the absence of health-supporting infrastructure and affordable healthy food options in poorer neighborhoods. Our findings highlight the need to revisit and implement measures in PRS studies (e.g., incentives and resources for follow-up care), as well as system-level policies to promote equity in genomic research and health outcomes.
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  • 文章类型: Journal Article
    机构审查委员会(IRB)对当地情况进行审查的性质含糊不清。对多中心试验进行单一IRB审查的要求需要更好地理解当地背景审查的解释和实施,以及如何最好地集中实施此类审查。我们通过探索利益相关者的态度和看法,寻求对IRB本地背景审查的务实理解。与26名IRB成员和工作人员进行了半结构化访谈,机构官员,研究人员与80项类似利益相关者的调查进行了整合,并通过基于主题的定性文本分析和描述性统计分析进行了分析。利益相关者描述了他们认为是当地的情况,地方背景审查的价值,以及用于实施对一般当地情况的审查以及除知情同意外进行的紧急情况研究的关键过程。与会者表达了集中审查当地情况的关切和潜在优势。视角的变化表明,本地背景审查不是一个离散的过程,这为定义单一IRB审查的途径提供了机会。
    The nature of the review of local context by institutional review boards (IRBs) is vague. Requirements for single IRB review of multicenter trials create a need to better understand interpretation and implementation of local-context review and how to best implement such reviews centrally. We sought a pragmatic understanding of IRB local-context review by exploring stakeholders\' attitudes and perceptions. Semistructured interviews with 26 IRB members and staff members, institutional officials, and investigators were integrated with 80 surveys of similar stakeholders and analyzed with qualitative theme-based text analysis and descriptive statistical analysis. Stakeholders described what they considered to be local context, the value of local-context review, and key processes used to implement review of local context in general and for emergency research conducted with an exception from informed consent. Concerns and potential advantages of centralized review of local context were expressed. Variability in perspectives suggests that local-context review is not a discrete process, which presents opportunities for defining pathways for single IRB review.
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  • 文章类型: Journal Article
    硼在化学中具有重要作用,生物学和材料科学。双原子过渡金属硼化物(MBs)是许多络合物和材料的组成部分,它们呈现出独特的电子结构,具有有趣和独特的性质,以及在这里分析的各种键合方案。在本文的第一部分,我们对第一行过渡金属硼化物的实验和理论研究进行了综述,即,ScB,TiB,VB,CrB,MnB,FeB,CoB,NiB,CuB,和ZnB;第二行过渡金属硼化物,即,YB,ZrB,NBB,MoB,TcB,RuB,RhB,PdB,AgB,和CdB;和第三行过渡金属硼化物,即,LaB,HfB,TAB,WB,ReB,OSB,IrB,PtB,AuB,和HgB。因此,在第二部分,使用B3LYP通过DFT计算研究第二行和第三行MB,TPSSh,和MN15函数和,在某些情况下,通过多参考方法,MRCISD+Q,结合aug-cc-pVQZ-PPM/aug-cc-pVQZB基础集。具体来说,粘结距离,离解能,频率,偶极矩,并报告了自然的NPA费用。沿着三行的MB分子之间的比较,并分析了它们的异同。还描述了双原子硼化物的键合;发现,除了RhB(X1Σ+),最近发现它形成了四重债券,RuB(X2Δ)和TcB(X3Σ-)也在其X态下形成四重σ2σ2π2π2键。此外,为了填补现有文献中存在的空白,在这里,我们计算TcB分子。
    Boron presents an important role in chemistry, biology, and materials science. Diatomic transition-metal borides (MBs) are the building blocks of many complexes and materials, and they present unique electronic structures with interesting and peculiar properties and a variety of bonding schemes which are analyzed here. In the first part of this paper, we present a review on the available experimental and theoretical studies on the first-row-transition-metal borides, i.e., ScB, TiB, VB, CrB, MnB, FeB, CoB, NiB, CuB, and ZnB; the second-row-transition-metal borides, i.e., YB, ZrB, NbB, MoB, TcB, RuB, RhB, PdB, AgB, and CdB; and the third-row-transition-metal borides, i.e., LaB, HfB, TaB, WB, ReB, OsB, IrB, PtB, AuB, and HgB. Consequently, in the second part, the second- and third-row MBs are studied via DFT calculations using the B3LYP, TPSSh, and MN15 functionals and, in some cases, via multi-reference methods, MRCISD+Q, in conjunction with the aug-cc-pVQZ-PPM/aug-cc-pVQZB basis sets. Specifically, bond distances, dissociation energies, frequencies, dipole moments, and natural NPA charges are reported. Comparisons between MB molecules along the three rows are presented, and their differences and similarities are analyzed. The bonding of the diatomic borides is also described; it is found that, apart from RhB(X1Σ+), which was just recently found to form quadruple bonds, RuB(X2Δ) and TcB(X3Σ-) also form quadruple σ2σ2π2π2 bonds in their X states. Moreover, to fill the gap existing in the current literature, here, we calculate the TcB molecule.
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  • 文章类型: Journal Article
    我们的图像识别系统采用深度学习模型来区分图像中的左右上肢,允许医生确定正确的手术位置。从实验结果来看,研究发现,本文提出的预防上肢手术错误部位的智能图像识别系统的准确率和召回率可以达到98%和93%,分别。结果证明,我们的人工智能图像识别系统(AIIRS)确实可以帮助骨科医生防止发生错误部位的左右上肢手术。同时,在未来,我们将根据我们的原型实验结果申请IRB,我们将进行第二阶段的人体试验。本文的研究结果对上肢骨科手术有很大的益处和研究价值。
    Our image recognition system employs a deep learning model to differentiate between the left and right upper limbs in images, allowing doctors to determine the correct surgical position. From the experimental results, it was found that the precision rate and the recall rate of the intelligent image recognition system for preventing wrong-site upper limb surgery proposed in this paper could reach 98% and 93%, respectively. The results proved that our Artificial Intelligence Image Recognition System (AIIRS) could indeed assist orthopedic surgeons in preventing the occurrence of wrong-site left and right upper limb surgery. At the same time, in future, we will apply for an IRB based on our prototype experimental results and we will conduct the second phase of human trials. The results of this research paper are of great benefit and research value to upper limb orthopedic surgery.
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  • 文章类型: Journal Article
    背景:在审查协议时,研究伦理委员会(REC,相当于机构审查委员会-IRB)有责任考虑拟议的研究是否合理。如果研究没有道理,它可以浪费参与者的时间,研究人员的时间和资源。由于RECs的构成并不涵盖科学或学术专业知识的所有领域,这可能是困难的区域经济共同体来决定研究是否科学或方法上合理,特别是在缺乏权威的(通常以系统的形式)审查。如果没有此类审查,一些人认为,REC应该坚持对现有证据进行新的审查,作为REC赞成意见的条件。然而,随着RECs回顾广泛的研究,此类请求必须与类型成比例,和程度,提议的项目。风险是可能影响REC确定新项目是否合理的证据需求程度的一个因素,但不是唯一的因素。这里描述的工作的目的是确定REC成员和研究人员是否将风险与研究方法的类型具体联系起来,如果是这样,这个链接是否可以用来帮助指导系统的需求,或其他,评论的类型。
    方法:我们进行了一项横断面研究,在2020年11月至2021年1月之间收集数据,以检查拟议的研究方法是否会影响REC对参与者的风险感知。我们以国际调查的形式向REC成员和研究人员介绍了31种研究方法。
    结果:我们收集了283个回答,其中包括定性和定量数据,关于研究方法如何影响参与者对风险的看法。我们使用这些数据得出结论,REC确实看到了风险与研究类型之间的联系。因此,我们通过1期和2期临床试验构建了风险等级,和临床心理学/精神病学干预研究,在顶部(即被认为是最危险的)。
    结论:我们讨论了这种层次结构是否有助于指导RECs在审查拟议的研究方案时应寻求的科学依据水平,并提交一页纸的指导表,以帮助RECs在他们的审查。
    When reviewing a protocol, research ethics committees (RECs, equivalent to institutional review boards - IRBs) have the responsibility to consider whether the proposed research is justified. If research is not justified, it can waste participants\' time, researchers\' time and resources. As RECs are not constituted to cover all areas of scientific or academic expertise, it can be difficult for RECs to decide whether research is scientifically or methodologically justified especially in the absence of authoritative (often in the form of systematic) reviews. Where such reviews are absent, some have argued that RECs should insist on a new review of existing evidence as a condition of the REC favourable opinion. However, as RECs review a wide range of research, such requests must be proportionate to the type, and extent, of proposed projects. Risk is one factor that may influence the extent of evidence need for a REC to determine that the new project is justified, but not the only factor. The aim of the work described here was to determine whether REC members and researchers specifically link risk to the type of research methodology, and if so, whether this link could be used to help guide the need for systematic, or other, types of reviews.
    We conducted a cross-sectional study, gathering data between November 2020 and January 2021, to examine whether proposed research methodologies impact how RECs perceive risk to participants. We presented 31 research methodologies to REC members and researchers in the form of an international survey.
    We collected 283 responses that included both qualitative and quantitative data as to how research methodology impacts perceptions of risk to participants. We used the data to conclude that RECs did see a link between risk and type of research. We therefore constructed a hierarchy of risk with Phase 1 and 2 clinical trials, and clinical psychology/psychiatry intervention studies, at the top (i.e. viewed as most risky).
    We discuss whether this hierarchy is useful for guiding RECs as to the level of scientific justification that they should seek when reviewing proposed research protocols, and present a one-page guidance sheet to help RECs during their reviews.
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  • 文章类型: Journal Article
    向学生讲授人类主题研究(HSR)的伦理学应成为学生研究教育的基本组成部分。在这篇文章中,我们分析了排名第一的文理学院(LAC)的机构审查委员会(IRB)网站,以检查由本科生进行的HSR框架。我们对美国50个排名最高的LAC进行的描述性定量分析表明,大多数IRB网站都提供有关本科生研究的信息,大多数包括关于学生的基于课堂的研究信息。我们对十个学院的子样本进行的定性内容分析IRB网站提供了有关他们如何告知和教育包括知情同意在内的问题的信息,并为包括研究顾问在内的学生突出了不同的资源。和纪律标准。最后,我们讨论了IRB对本科生的可及性的建议。
    Teaching students about the ethics of Human Subject Research (HSR) should be a fundamental component of students\' education about research. In this article, we analyze the Institutional Review Board (IRB) websites of top-ranked Liberal Arts Colleges (LACs) to examine their framing of HSR carried out by undergraduate students. Our descriptive quantitative analysis from 50 top-ranked LACs in the United States indicates that a majority of IRB websites provide information about undergraduate research, and most include information about students\' classroom-based research. Our qualitative content analysis of a subsample of ten colleges\' IRB websites provides information on how they inform and educate about issues including informed consent and highlight different resources for students including their research advisor, and disciplinary standards. We conclude by discussing recommendations for IRBs in their accessibility to undergraduates.
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  • 文章类型: Journal Article
    移动健康(mHealth)技术对用户隐私和机密性提出了独特的风险,这些风险通常嵌入在冗长而复杂的隐私政策中。使用条款,和最终用户许可协议。我们寻求通过提供一个框架来识别这些风险何时是研究风险,从而改善使用mHealth技术的研究中对这些文件(“用户协议”)及其风险的伦理审查。将这些协议中的关键信息分类为相关的道德和监管类别,并提出减轻它们的策略。MHealth用户协议通常描述mHealth技术收集的数据的性质,为什么或出于什么目的收集和共享用户数据,谁将有权访问收集的不同类型的数据,并可能包括免责的语言。数据收集和共享带来的风险通常随着数据的敏感性和可识别性而增加,并因数据是否与研究人员共享而有所不同,技术开发商,和/或第三方实体。最重要的风险缓解策略是在研究同意过程中向参与者披露用户协议中的关键信息。此外,研究人员应该优先考虑具有有利风险-收益平衡的mHealth技术。
    Mobile health (mHealth) technologies raise unique risks to user privacy and confidentiality that are often embedded in lengthy and complex Privacy Policies, Terms of Use, and End User License Agreements. We seek to improve the ethical review of these documents (\'user agreements\') and their risks in research using mHealth technologies by providing a framework for identifying when these risks are research risks, categorizing the key information in these agreements under relevant ethical and regulatory categories, and proposing strategies to mitigate them. MHealth user agreements typically describe the nature of the data collected by mHealth technologies, why or for what purposes user data are collected and shared, who will have access to the different types of data collected, and may include exculpatory language. The risks raised by data collection and sharing typically increase with the sensitivity and identifiability of the data and vary by whether data are shared with researchers, the technology developer, and/or third-party entities. The most important risk mitigation strategy is disclosure of the key information found in user agreements to participants during the research consent process. In addition, researchers should prioritize mHealth technologies with favorable risk-benefit balances.
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  • 文章类型: Journal Article
    公民科学的协作性质提出了有关管理其研究成果所有权的重要问题。潜在的公民科学研究产出包括数据集,调查结果,出版物,和新思想的发现,方法,产品,和技术。与其他学科的公民科学项目不同,生物医学公民科学项目通常包括功能,例如个人健康数据的贡献,这可能会提高公民科学家对他们能够访问的期望,control,或分享项目产出的收益。这里,我们指的是接触的道德要求,control,以及作为所有权要求的利益,以及项目对所有权索赔的管理作为其所有权实践。所有权的伦理管理被广泛认为是公民科学项目的重要考虑因素,以及从业人员和学者已经描述了有益的建议,以抢占问题并使利益相关者参与实践。在这些文献的基础上,我们提出了一个框架,以帮助生物医学公民科学项目系统地评估其所有权实践的道德合理性,基于四个考虑因素:互惠治疗,相对治疗,风险效益评估,合理的期望。
    The collaborative nature of citizen science raises important questions about managing ownership of its research outputs. Potential citizen science research outputs include data sets, findings, publications, and discoveries of new ideas, methods, products, and technologies. Unlike citizen science projects conducted in other disciplines, biomedical citizen science projects often include features, such as contribution of personal health data, that might heighten citizen scientists\' expectations that they will be able to access, control, or share in the benefits of project outputs. Here, we refer to moral claims of access, control, and benefit as ownership claims, and a project\'s management of ownership claims as its ownership practices. Ethical management of ownership is widely recognized as an important consideration for citizen science projects, and practitioners and scholars have described helpful recommendations for preempting issues and engaging stakeholders on practices. Building on this literature, we propose a framework to help biomedical citizen science projects systematically evaluate the ethical soundness of their ownership practices based on four considerations: reciprocal treatment, relative treatment, risk-benefit assessment, and reasonable expectations.
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  • 文章类型: Journal Article
    本文探讨了根据《精神能力法》对痴呆症患者进行正式道德监管的合法性,2005年在英格兰和威尔士。根据该法案,在被诊断患有痴呆症的人中进行的研究必须得到卫生研究管理局委员会的批准,无论该研究是否与卫生组织或服务使用者接触。作为例子,我讨论了两项与医疗保健服务无关的人种学痴呆症研究,但这仍然需要HRA的批准。这些情况引发了有关痴呆症治理中的合法性和互惠性的问题。通过能力立法,国家控制痴呆症患者,自动将他们划分为医疗保健对象,因为他们的诊断。这种诊断作为一种行政医学形式,使痴呆症成为医疗实体,而被诊断患有痴呆症的人成为正规医疗保健的财产。然而,英格兰和威尔士的许多痴呆症患者除了诊断外没有获得相关的健康或护理服务。这种高度治理和低支持的体制失衡破坏了痴呆症患者的契约公民身份,其中国家公民的权利和责任应该是对等的。作为回应,我认为人种学研究中对这一系统的抵制。这里的“抵抗”不一定是故意的,敌意,困难的或感知的,而是包含与权力或控制相反的微观政治效应,有时来自系统本身,而不是单个电阻行为者。抵抗可能是无意的,通过平凡的失败来满足治理官僚机构的特定方面。它也可以是故意的,通过拒绝遵守看似繁琐的限制,不适用或不道德,可能引发渎职和不当行为的问题。我认为,由于治理官僚机构的扩大,抵抗的可能性更大。一方面,无意和有意越轨的可能性增加,而另一方面,这些违法行为被发现和纠正的能力下降,因为维持对这样一个系统的控制需要大量的资源。在这场道德官僚骚乱的背后,痴呆症患者本身在很大程度上是看不见的。痴呆症患者通常与决定其研究参与的委员会没有互动。这进一步使道德治理成为痴呆症研究经济的特别剥夺权利的方面。该州规定,痴呆症患者必须因其诊断而受到区别对待,不咨询那些人。作为回应,对不道德治理的抵制可以直观地认为是道德本身,但我建议这样一个简单的二进制有点误导。
    This paper interrogates the legitimacy of formal ethical regulation regarding people with dementia under the Mental Capacity Act, 2005 in England and Wales. Under the Act, research among people diagnosed with dementia must be approved by Health Research Authority committees, irrespective of whether that research engages with health organisations or service users. As examples, I discuss two ethnographic dementia studies that do not engage with healthcare services, but which nonetheless require HRA approval. These instances raise questions regarding legitimacy and reciprocity in the governance of dementia. Through capacity legislation, the state exerts control over people with dementia, automatically delineating them as healthcare subjects because of their diagnoses. This diagnosis functions as a form of administrative medicalisation, rendering dementia a medical entity and those diagnosed with it the property of formal healthcare. However, many people with dementia in England and Wales do not receive related health or care services beyond diagnosis. This institutional imbalance of high governance and low support undermines the contractual citizenship of people with dementia, wherein state-citizen rights and responsibilities should be reciprocal. In response, I consider resistance to this system in ethnographic research. \"Resistance\" here is not necessarily deliberate, hostile, difficult or perceived, but rather encompasses micropolitical effects that are contrary to power or control, sometimes emerging from systems themselves rather than individual resistive actors. Resistance can be unintentional, through mundane failures to satisfy specific aspects of governance bureaucracies. It can also be deliberate, through refusals to comply with restrictions that seem cumbersome, inapplicable or unethical, potentially raising questions of malpractice and misconduct. I suggest that resistance is made more probable due to the expansion of governance bureaucracies. On the one hand, the potential for both unintentional and intentional transgression increases, while on the other hand, the capacity for those transgressions to be discovered and rectified decreases, because the maintenance of control over such a system requires vast resources. Behind this ethico-bureaucratic tumult, people with dementia themselves are largely invisible. People with dementia often have no interaction with committees that determine their research participation. This further renders ethical governance a particularly disenfranchising facet of the dementia research economy. The state stipulates that people with dementia must be treated differently because of their diagnoses, without consulting those people. In response, resistance to unethical governance could be intuitively deemed ethical per se, but I suggest that such a simplistic binary is somewhat misleading.
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  • 文章类型: Journal Article
    人-非人嵌合研究-对含有人类细胞的非人动物的研究-被用于了解人类疾病和发育,并创造潜在的人类治疗方法,如可移植器官。嵌合模型的一个优点是它们可以近似人类生物学,因此允许科学家了解和改善人类健康,而不会冒对人类造成伤害的风险。正在探索的新兴伦理问题之一是,嵌合体在什么时候“足够人类”才能拥有人权,因此比目前提供给非人类动物的研究保护标准更高。然而,这个问题和其他相关问题假设在非人类动物上实验的伦理已经解决,他们没有。在这篇文章中,我们认为,必须充分关注有关非人类动物研究的熟悉问题以及有关嵌合体研究的新问题,否则将导致对嵌合体研究伦理的扭曲理解。
    Human-nonhuman chimeric research-research on nonhuman animals who contain human cells-is being used to understand human disease and development and to create potential human treatments such as transplantable organs. A proposed advantage of chimeric models is that they can approximate human biology and therefore allow scientists to learn about and improve human health without risking harms to humans. Among the emerging ethical issues being explored is the question of at what point chimeras are \"human enough\" to have human rights and thus be owed higher standards of research protection than that currently afforded to nonhuman animals. However, this question and other related questions assume that the ethics of experimenting on nonhuman animals have been settled, which they have not. In this essay, we argue that it is imperative to give adequate attention to familiar questions about nonhuman animal research as well as new questions about chimera research and that failure to do so will result in a distorted understanding of the ethics of chimera research.
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