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Journal editors and publishers’ legal obligations with respect to medical research misconduct 期刊编辑和出版商在医学研究不端行为方面的法律义务
IF 1.7 Q1 Arts and Humanities Pub Date : 2022-12-25 DOI: 10.1177/17470161221147440
Naomi Holbeach, Ian Freckelton Ao Qc, Bency Mol
As the burden of misconduct in medical research is increasingly recognised, questions have been raised about how best to address this problem. Whilst there are existing mechanisms for the investigation and management of misconduct in medical literature, they are inadequate to deal with the magnitude of the problem. Journal editors and publishers play an essential role in protecting the veracity of the medical literature. Whilst ethical guidance for journal editors and publishers is important, it is not as readily enforceable as legal obligations might be. This article questions the legal obligations that might exist for journal editors and publishing companies with respect to ensuring the veracity of the published literature. Ultimately, there is no enforceable legal obligation in Australia, the United Kingdom, or the United States. In light of this, more robust mechanisms are needed to deliver greater confidence and transparency in the investigative process, the management of concerns or findings of misconduct and the need to cleanse the literature. We show that the law disincentivises journals and publishers from ensuring truth in their publications. There are harmful consequences for medical care and public confidence in the medical profession and health care system when the foundations of medical science are questionable.
随着医学研究不端行为的负担日益得到承认,人们提出了如何最好地解决这一问题的问题。虽然有现有的机制来调查和管理医学文献中的不当行为,但它们不足以处理这个问题的严重性。期刊编辑和出版商在保护医学文献的真实性方面发挥着至关重要的作用。虽然期刊编辑和出版商的道德指导很重要,但它并不像法律义务那样容易执行。本文对期刊编辑和出版公司在确保已发表文献的真实性方面可能存在的法律义务提出了质疑。最终,在澳大利亚、英国或美国没有强制执行的法律义务。有鉴于此,我们需要更健全的机制,在调查过程中提供更大的信心和透明度,管理不当行为的担忧或发现,以及清理文献的需要。我们表明,法律不利于期刊和出版商确保其出版物的真实性。当医学科学的基础受到质疑时,医疗保健和公众对医疗专业和卫生保健系统的信心都会受到有害的影响。
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引用次数: 0
The ethics review and the humanities and social sciences: disciplinary distinctions in ethics review processes 伦理审查与人文社会科学:伦理审查过程中的学科差异
IF 1.7 Q1 Arts and Humanities Pub Date : 2022-12-25 DOI: 10.1177/17470161221147202
Jessica Carniel, A. Hickey, Kim Southey, Annette Brömdal, Lynda Crowley-Cyr, Douglas C. Eacersall, William F Farmer, R. Gehrmann, T. Machin, Yosheen Pillay
Ethics review processes are frequently perceived as extending from codes and protocols rooted in biomedical disciplines. As a result, many researchers in the humanities and social sciences (HASS) find these processes to be misaligned, if not outrightly obstructive to their research. This leads some scholars to advocate against HASS participation in institutional review processes as they currently stand, or in their entirety. While ethics review processes can present a challenge to HASS researchers, these are not insurmountable and, in fact, present opportunities for ethics review boards (ERBs) to mediate their practices to better attend to the concerns of the HASS disciplines. By highlighting the potential value of the ethics review process in recognising the nuances and specificity across different forms of research, this article explores the generative possibilities of greater collaboration between HASS researchers and ERBs. Remaining cognisant of the epistemic and methodological differences that mark different disciplinary formations in turn will benefit the ethical conduct of all researchers.
伦理审查过程经常被认为是从植根于生物医学学科的规范和协议延伸出来的。因此,许多人文社会科学(HASS)的研究人员发现这些过程是不一致的,如果不是完全阻碍他们的研究的话。这导致一些学者主张反对HASS参与机构审查过程,因为他们目前的立场,或全部。虽然伦理审查过程可能给HASS研究人员带来挑战,但这些挑战并不是不可克服的,事实上,伦理审查委员会(erb)有机会调解他们的做法,以更好地关注HASS学科的关注。通过强调伦理审查过程在识别不同研究形式的细微差别和特异性方面的潜在价值,本文探讨了HASS研究人员和erb之间加强合作的产生可能性。认识到标志着不同学科形成的认识论和方法论差异,反过来将有利于所有研究人员的伦理行为。
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引用次数: 3
Promising practices and constraining factors in mobilizing community-engaged research 动员社区参与研究的前景实践和制约因素
IF 1.7 Q1 Arts and Humanities Pub Date : 2022-11-30 DOI: 10.1177/17470161221141275
Michelle Lam, Akech Mayuom
This article describes a project involving 13 community focus groups on the topic of anti-racism and belonging where the researchers concluded each group with a robust discussion about how the group would prefer to receive the findings from the project. Analysis of this data, existing literature, and the practical experiences of the researchers revealed that while there are multiple “bridges” researchers can take to connect their research with community-level users, and although it is desirable to offer tailored approaches for specific audiences, there are significant barriers and challenges for truly effective engagement. By describing the various factors that determined which bridges were taken, we hope to help other community-based researchers imagine new ways of mobilizing knowledge, consider promising practices to guide the connection of knowledge to the community and shine a light on the very real constraints of time, budget, personnel, and university system considerations that impact knowledge mobilization decisions.
本文描述了一个涉及13个社区焦点小组的项目,主题是反种族主义和归属,研究人员对每个小组进行了热烈的讨论,讨论该小组更愿意接受项目的研究结果。对这些数据、现有文献和研究人员的实践经验的分析表明,尽管研究人员可以利用多种“桥梁”将他们的研究与社区级用户联系起来,尽管为特定受众提供量身定制的方法是可取的,但真正有效的参与存在重大障碍和挑战。通过描述决定采取哪些桥梁的各种因素,我们希望帮助其他以社区为基础的研究人员想象动员知识的新方法,考虑有前途的实践来指导知识与社区的联系,并照亮影响知识动员决策的时间,预算,人员和大学系统考虑的非常现实的限制。
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引用次数: 0
Research ethics in a changing social sciences landscape 不断变化的社会科学景观中的研究伦理
IF 1.7 Q1 Arts and Humanities Pub Date : 2022-11-29 DOI: 10.1177/17470161221141011
N. Brown
The role of research ethics committees, and research ethics issues more broadly are often not viewed in the context of the development of scientific methods and the academic community. This topic piece seeks to redress this gap. I begin with a brief outline of the changes we experience within the social sciences before exploring in more detail their impact on research ethics and the practices of research ethics committees. I conclude with recommendations for how the existing research ethics processes may be made more future-proof.
研究伦理委员会的作用,以及更广泛的研究伦理问题,往往不是在科学方法和学术界发展的背景下看待的。这篇专题文章试图弥补这一差距。我首先简要概述了我们在社会科学领域所经历的变化,然后再详细探讨它们对研究伦理和研究伦理委员会的实践的影响。最后,我就如何使现有的研究伦理程序更经得起未来的考验提出了建议。
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引用次数: 4
‘But how will you ensure the objectivity of the researcher?’ Guidelines to address possible misconceptions about the ethical imperatives of community-based research “但你如何确保研究人员的客观性?”解决对基于社区的研究的伦理必要性可能存在的误解的指导方针
IF 1.7 Q1 Arts and Humanities Pub Date : 2022-11-21 DOI: 10.1177/17470161221135882
L. Wood, S. Kahts-Kramer
Many reviewers of applications for ethical approval of research at universities struggle to understand what is considered ethical conduct in community-based research (CBR). Their difficulty in understanding CBR and the ethics embedded within it is, in part, due to the exclusion of CBR from researchers’ mandatory research ethics training. After all, CBR challenges both pedagogically and epistemologically the dominant paradigm/s whose worldviews, values and inherent structures of power help sustain the status quo within academic institutions at large. Consequently, CBR ethics applications are often prolonged due to back-and-forth rebuttals. In this article, we analyse our experiences in a South African institution of the ethics approval process for our various CBR projects over the past couple of years. Data for this purpose was generated from analysis of our reflexive dialogues as well as our responses to feedback from the ethics review boards. To help support the trustworthiness of the study, we invited critical friends to a workshop to engage with our findings. We identified three main themes all associated with how the values, worldviews and approaches of CBR differ from those of the dominant research paradigm/s, that impeded on the progress of our applications through the ethics approval process. On the basis of our analysis, we offer guidelines and a participatory research checklist for university ethics review panels to help inform their evaluation of applications concerning CBR. While universities now actively promote community engagement initiatives, and since CBR is an efficacious approach to that end, we advocate for inclusion of CBR ethics in universities’ mandatory ethics training, to help address ethical concerns that impede CBR research.
许多大学研究伦理批准申请的审稿人很难理解什么是基于社区的研究(CBR)中的伦理行为。他们之所以难以理解CBR及其内含的伦理,部分原因是由于研究者在强制性的研究伦理培训中被排除了CBR。毕竟,CBR在教学和认识论上都挑战了主流范式,这些范式的世界观、价值观和内在的权力结构有助于维持整个学术机构的现状。因此,CBR伦理应用往往由于反复的反驳而延长。在本文中,我们分析了过去几年中我们在一家南非机构为我们的各种CBR项目进行伦理审批过程的经验。这方面的数据来自我们对反思性对话的分析,以及我们对伦理审查委员会反馈的回应。为了支持这项研究的可信度,我们邀请了一些挑剔的朋友参加一个研讨会,参与我们的研究结果。我们确定了三个主要主题,它们都与CBR的价值观、世界观和方法与主流研究范式的不同有关,这些都阻碍了我们的应用程序通过伦理审批过程的进展。基于我们的分析,我们为大学伦理审查小组提供了指导方针和参与性研究清单,以帮助他们评估有关CBR的申请。鉴于大学目前积极推动社区参与倡议,而CBR是实现这一目标的有效途径,我们主张将CBR伦理纳入大学的强制性伦理培训,以帮助解决阻碍CBR研究的伦理问题。
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引用次数: 1
Engaging key stakeholders to overcome barriers to studying the quality of research ethics oversight 与主要利益相关者合作,克服研究伦理监督质量方面的障碍
IF 1.7 Q1 Arts and Humanities Pub Date : 2022-11-18 DOI: 10.1177/17470161221138028
E. Anderson, Elisa A. Hurley, Kimberley Serpico, Ann R. Johnson, Jessica Rowe, Megan Singleton, Barbara E. Bierer, Brooke Cholka, S. Chaudhari, Holly Fernandez Lynch
The primary purpose of Institutional Review Boards (IRBs) is to protect the rights and welfare of human research participants. Evaluation and measurement of how IRBs satisfy this purpose and other important goals are open questions that demand empirical research. Research on IRBs, and the Human Research Protection Programs (HRPPs) of which they are often a part, is necessary to inform evidence-based practices, policies, and approaches to quality improvement in human research protections. However, to date, HRPP and IRB engagement in empirical research about their own activities and performance has been limited. To promote engagement of HRPPs and IRBs in self-reflective research on HRPP and IRB quality and effectiveness, barriers to their participation need to be addressed. These include: extensive workloads, limited information technology systems, and few universally accepted or consistently measured metrics for HRPP/IRB quality and effectiveness. Additionally, institutional leaders may have concerns about confidentiality. Professional norms around the value of participating in this type of research are lacking. Lastly, obtaining external funding for research on IRBs and HRPPs is challenging. As a group of HRPP professionals and researchers actively involved in a research consortium focused on IRB quality and effectiveness, we identify potential levers for supporting and encouraging HRPP and IRB engagement in research on quality and effectiveness. We maintain that this research should be informed by the core principles of patient- and community-engaged research, in which members and key stakeholders of the community to be studied are included as key informants and members of the research team. This ensures that relevant questions are asked and that data are interpreted to produce meaningful recommendations. As such, we offer several ways to increase the participation of HRPP professionals in research as participants, as data sharers, and as investigators.
机构审查委员会(irb)的主要目的是保护人类研究参与者的权利和福利。评估和测量irb如何满足这一目的和其他重要目标是需要实证研究的开放问题。对irb和人类研究保护计划(HRPPs)的研究是必要的,可以为基于证据的实践、政策和方法提供信息,以提高人类研究保护的质量。然而,迄今为止,HRPP和IRB对其自身活动和绩效的实证研究仍然有限。为了促进HRPP和IRB参与关于HRPP和IRB质量和有效性的自我反思研究,需要解决阻碍他们参与的障碍。这些问题包括:大量的工作量,有限的信息技术系统,以及很少普遍接受或一致测量HRPP/IRB质量和有效性的度量标准。此外,机构领导人可能会担心保密问题。缺乏关于参与这类研究的价值的专业规范。最后,为irb和hrpp的研究获得外部资金是具有挑战性的。作为一群HRPP专业人员和研究人员积极参与一个研究联盟,专注于IRB的质量和有效性,我们确定了支持和鼓励HRPP和IRB参与质量和有效性研究的潜在杠杆。我们认为,这项研究应遵循患者和社区参与研究的核心原则,其中包括被研究社区的成员和主要利益相关者,作为关键线人和研究团队的成员。这可以确保提出相关的问题,并解释数据以产生有意义的建议。因此,我们提供了几种方法来增加HRPP专业人员作为参与者、数据共享者和调查人员参与研究。
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引用次数: 3
Safeguarding research staff “in the field”: a blind spot in ethics guidelines 保护科研人员“在现场”:伦理准则的盲点
IF 1.7 Q1 Arts and Humanities Pub Date : 2022-11-14 DOI: 10.1177/17470161221131494
Lennart Kaplan, J. Kuhnt, Laura E Picot, C. Grasham
Across disciplines there is a large and increasing number of research projects that rely on data collection activities in low- and middle-income countries (LMICs). However, these are accompanied by an extensive range of ethical challenges. While the safeguarding of study participants is the primary aim of existing ethics guidelines, this paper argues that this “do no harm” principle should be extended to include research staff. This study is a comprehensive review of more than 80 existing ethics guidelines and protocols that reveals a lack of safeguarding research staff regarding the ethical challenges faced during data collection activities in LMICs. This is particularly the case when it comes to issues such as power imbalances, political risk, staff’s emotional wellbeing or dealing with feelings of guilt. Lead organizations are called upon to develop guiding principles that encompass the safeguarding of research staff, which are then to be adapted and translated into specific protocols and tools by institutions.
在低收入和中等收入国家,依赖数据收集活动的跨学科研究项目数量众多,而且数量还在不断增加。然而,这些都伴随着广泛的道德挑战。虽然保护研究参与者是现有伦理准则的主要目的,但本文认为,这一“不伤害”原则应扩大到包括研究人员。本研究是对80多项现有伦理准则和协议的全面审查,揭示了在中低收入国家数据收集活动中缺乏对研究人员的道德挑战的保障。在涉及权力失衡、政治风险、员工情绪健康或处理内疚感等问题时尤其如此。呼吁领导组织制定包括保护研究人员在内的指导原则,然后由各机构加以调整并转化为具体的协议和工具。
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引用次数: 1
Authorship disputes and patient research participation: collaborating across backgrounds 作者争议和患者研究参与:跨背景合作
IF 1.7 Q1 Arts and Humanities Pub Date : 2022-11-10 DOI: 10.1177/17470161221134023
Will Hall
Public participation and survivor research in mental health are widely recognized as vital to the field. At the same time, contributions of patient collaborators can present unique challenges to determining authorship. Using an unresolved dispute around research contributions to the American Psychiatric Association’s Psychiatric Services journal, authorship and contribution are addressed. Recommendations are suggested to prevent dilemmas and achieve responsible research credit inclusion, especially among researchers with different backgrounds and asymmetric power relations. Researchers and publishers can prepare proactively for conflict through consensus on authorship criteria, prior agreements around author inclusion, arrangement for third party dispute resolution, transparency in communication and contracts, notification to prospective publications of pending disputes, a contributor-guarantor model of contribution, journal editor “expressions of concern” when authorship disputes go unresolved, and expectation of conflict as generative.
公众参与和幸存者研究在心理健康领域被广泛认为是至关重要的。与此同时,患者合作者的贡献可能对确定作者身份提出独特的挑战。在美国精神病学协会的《精神病学服务》杂志上,作者身份和贡献是一个悬而未决的争论。针对不同背景和不对称权力关系的研究人员,本文提出了防止困境和实现负责任的科研信用包容的建议。研究人员和出版商可以通过以下方式积极应对冲突:作者身份标准的共识、作者纳入的事先协议、第三方争议解决的安排、沟通和合同的透明度、对未决争议的潜在出版物的通知、贡献者-担保人的贡献模式、期刊编辑在作者身份争议未解决时的“关注表达”,以及对冲突产生的预期。
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引用次数: 0
Peer review and the pillar of salt: a case study 同行评议和盐的支柱:一个案例研究
IF 1.7 Q1 Arts and Humanities Pub Date : 2022-11-01 DOI: 10.1177/17470161221131491
J. Powell
Peer review has long been regarded as the gold standard of scientific publication, essential to the integrity of science itself. But, as any publishing scientist knows, peer review has its downside, including long delays and reviewer bias. Until the coming of the Internet, there appeared to be no alternative. Now, articles appear online as preprints almost immediately upon submission. But they lack peer review and thus their scientific standing can be questioned. Post-publication discussion platforms such as PubPeer have proven useful, but are no substitute for pre-publication peer review. Nevertheless, some may be tempted to believe that peer review can now be done without. This article challenges that view by analyzing a recent, non-peer-reviewed article in Skeptical Enquirer, a magazine published by the Committee for Skeptical Enquiry (CSI). The article, “Sodom Meteor Strike Claims Should Be Taken With a Pillar of Salt,” casts doubt on one of the most widely read scientific articles of the last decade and provides a stern warning of the cost of abandoning peer review.
长期以来,同行评议一直被视为科学出版的黄金标准,对科学本身的完整性至关重要。但是,正如任何出版科学家所知,同行评议有其缺点,包括长时间的延迟和审稿人的偏见。在互联网出现之前,似乎没有其他选择。现在,文章几乎在提交后立即以预印本的形式出现在网上。但他们缺乏同行评议,因此他们的科学地位可能受到质疑。出版后讨论平台(如PubPeer)已被证明是有用的,但不能取代出版前的同行评议。然而,有些人可能会倾向于认为,同行评议现在可以不用。这篇文章通过分析一篇最近发表在怀疑论调查委员会(CSI)出版的杂志《怀疑论询问者》上的非同行评议文章,挑战了这一观点。这篇题为《索多玛流星撞击的说法应该被怀疑》的文章对过去十年中阅读量最大的科学文章之一提出了质疑,并对放弃同行评议的代价提出了严厉警告。
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引用次数: 1
WITHDRAWN—Administrative Duplicate Publication: Research ethics committees: The ineligibles 行政副本出版物:研究伦理委员会:不合格者
IF 1.7 Q1 Arts and Humanities Pub Date : 2022-09-30 DOI: 10.1177/17470161221125530
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引用次数: 0
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Research Ethics
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