Journal of Empirical Research on Human Research Ethics最新文献

英文中文

Faculty Members' Perceptions and Attitudes Towards Anti-Plagiarism Detection Tools: Applying the Theory of Planned Behavior. 教师对反抄袭检测工具的认知与态度:运用计划行为理论。

IF 1.3 4区哲学 Q2 ETHICS

Journal of Empirical Research on Human Research Ethics

Pub Date : 2022-07-01 DOI: 10.1177/15562646221078655

Rasha M Arabyat, Bashar R Qawasmeh, Sayer I Al-Azzam, Mohammad B Nusair, Karem H Alzoubi

Objective: To evaluate predictors of the use of anti-plagiarism detection tools (APTs) in higher education institutions.

Methods: An online survey based on the theory of planned behavior was sent to members of science faculties in Jordan. Multivariate Logistic regression was conducted to determine predictors of previous use of APTs, and multivariate linear regression to predict future intentions.

Results: A total of 173 faculty members completed the survey, with 78.13% indicating previous APTs use. Turnitin® (43%) and Ithenticate® (32.8%) were the most commonly used APTs. These tools were mainly used to evaluate papers before sending them to journals (65.5%) and to detect plagiarism in theses/dissertations (50.4%). Predictors of previous use were academic rank (p = 0.02) and perceived understanding of APT use (p = 0.043). Intentions for future use were predicted by attitudes (p < 0.001) and perceived behavioral control (p = 0.036).

Conclusion: The theory of planned behavior successfully predicted intentions to use APTs. The use of APTs should be encouraged to all faculty members and students.

目的:探讨高校反抄袭检测工具(APTs)使用的预测因素。方法:以计划行为理论为基础，对约旦的科学院系成员进行在线调查。采用多元逻辑回归确定既往使用APTs的预测因素，并采用多元线性回归预测未来使用意向。结果:共有173名教师完成了调查，78.13%的人表示以前使用过APTs。Turnitin®(43%)和Ithenticate®(32.8%)是最常用的APTs。这些工具主要用于论文投稿前的评估(65.5%)和检测论文/学位论文的抄袭(50.4%)。预测因子为学术等级(p = 0.02)和对APT使用的感知理解(p = 0.043)。结论:计划行为理论成功地预测了apt的使用意向。应该鼓励所有教师和学生使用apt。

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引用次数: 3

Tribal Deliberations about Precision Medicine Research: Addressing Diversity and Inequity in Democratic Deliberation Design and Evaluation. 关于精准医学研究的部落商议：解决民主商议设计和评估中的多样性和不公平问题。

IF 1.3 4区哲学 Q2 ETHICS

Journal of Empirical Research on Human Research Ethics

Pub Date : 2022-07-01 Epub Date: 2022-02-28 DOI: 10.1177/15562646221081267

Erika Blacksher, Susan Brown Trinidad, R Brian Woodbury, Scarlett E Hopkins, Erica L Woodahl, Bert B Boyer, Wylie Burke, Vanessa Hiratsuka

Deliberative democratic engagement is used around the globe to gather informed public input on contentious collective questions. Yet, rarely has it been used to convene individuals exclusively from Indigenous communities. The relative novelty of using this approach to engage tribal communities and concerns about diversity and inequities raise important methodological questions. We describe the design and quality outcomes for a 2.5-day deliberation that elicited views of American Indian and Alaska Native (AIAN) leaders about the potential value and ethical conduct of precision medicine research (PMR), an emerging approach to research that investigates the health effects of individual genetic variation in tandem with variation in health-relevant practices, social determinants, and environmental exposures. The event met key goals, such as relationship and rapport formation, cross-site learning, equality of opportunity to participate, and respect among participants in the context of disagreement.

慎思民主参与在全球各地都被用来收集公众对有争议的集体问题的知情意见。然而，这种方法很少被用来召集专门来自土著社区的个人。使用这种方法让部落社区参与进来相对比较新颖，而且人们对多样性和不平等的关注也提出了重要的方法问题。我们介绍了一次为期 2.5 天的讨论的设计和质量成果，这次讨论征求了美国印第安人和阿拉斯加原住民 (AIAN) 领导人对精准医学研究 (PMR) 的潜在价值和道德行为的看法，PMR 是一种新兴的研究方法，它研究个体基因变异对健康的影响，同时研究与健康相关的实践、社会决定因素和环境暴露的变异。此次活动实现了一些关键目标，如建立关系和默契、跨站点学习、平等参与机会以及在存在分歧的情况下尊重参与者。

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引用次数: 1

Consent Requirements for Testing Health Policies: An Intercontinental Comparison of Expert Opinions. 检测健康政策的同意要求：专家意见的洲际比较

IF 1.7 4区哲学 Q2 ETHICS

Journal of Empirical Research on Human Research Ethics

Pub Date : 2022-07-01 Epub Date: 2022-02-10 DOI: 10.1177/15562646221076764

Astrid Berner-Rodoreda, Shannon McMahon, Nir Eyal, Puspita Hossain, Atonu Rabbani, Mrittika Barua, Malabika Sarker, Emmy Metta, Elia Mmbaga, Melkizedeck Leshabari, Daniel Wikler, Till Bärnighausen

Individual informed consent is a central requirement for clinical research on human subjects, yet whether and how consent requirements should apply to health policy experiments (HPEs) remains unclear. HPEs test and evaluate public health policies prior to implementation. We interviewed 58 health experts in Tanzania, Bangladesh and Germany on informed consent requirements for HPEs. Health experts across all countries favored a strong evidence base, prior information to the affected populations, and individual consent for 'risky' HPEs. Differences pertained to individual risk perception, how and when consent by group representatives should be obtained and whether HPEs could be treated as health policies. The study adds to representative consent options for HPEs, yet shows that more research is needed in this field - particularly in the present Covid-19 pandemic which has highlighted the need for HPEs nationally and globally.

个人知情同意是人类受试者临床研究的核心要求，但同意要求是否以及如何适用于卫生政策实验仍不清楚。HPE在实施之前测试和评估公共卫生政策。我们采访了坦桑尼亚、孟加拉国和德国的58位卫生专家，了解HPE的知情同意要求。所有国家的卫生专家都支持建立强有力的证据基础，向受影响人群提供事先信息，并对“危险”的高氟氯烃给予个人同意。差异涉及个人风险认知、应如何以及何时获得团体代表的同意，以及是否可以将HPE视为健康政策。该研究增加了HPE的代表性同意选择，但表明该领域需要更多的研究，尤其是在当前新冠肺炎大流行中，这突出了全国和全球对HPE的需求。

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引用次数: 0

Ethical Analysis of Egypt's Law Regulating Clinical Research 埃及规范临床研究的法律伦理分析

IF 1.3 4区哲学 Q2 ETHICS

Journal of Empirical Research on Human Research Ethics

Pub Date : 2022-05-16 DOI: 10.1177/15562646221096188

A. Matar, H. Silverman

Lately, there has been increased research performed in Egypt. In response, the Egyptian Parliament published its first clinical research law in December 2020. The official version of the law was translated to English from Arabic and back by an accredited translation service. We performed an ethical analysis of the law based on the seven ethical requirements for clinical research proposed by Emanuel et al. and compared it with other regulations in the Arab region. The law contains provisions that fulfill all requirements for ethical research to varying degree. Provisions necessitating the sharing of participants’ data and biospecimens by the Central Intelligence Agency requires further specifications to ensure privacy protection. Also, the law poses problematic liabilities that could hamper medical research. Egypt's law compares favorably with other laws in the region. Potential items that require further specification can be addressed in the executive regulations currently being drafted for the law.

最近，在埃及进行了更多的研究。作为回应，埃及议会于2020年12月公布了首部临床研究法。该法律的官方版本由一家经过认证的翻译机构从阿拉伯语翻译成英语。我们根据Emanuel等人提出的临床研究的七项伦理要求对该法律进行了伦理分析，并将其与阿拉伯地区的其他法规进行了比较。该法律包含的条款在不同程度上满足了伦理研究的所有要求。要求中央情报局共享参与者数据和生物标本的规定需要进一步规范，以确保隐私保护。此外，该法律还提出了可能妨碍医学研究的问题责任。埃及的法律与该地区的其他法律相比较为有利。需要进一步说明的潜在项目可以在目前为该法律起草的行政法规中加以解决。

引用次数: 1

Capacity Development of Research Ethics Administrators: Scoping Review 研究伦理管理者的能力发展:范围审查

IF 1.3 4区哲学 Q2 ETHICS

Journal of Empirical Research on Human Research Ethics

Pub Date : 2022-04-27 DOI: 10.1177/15562646221097044

M. Mulondo, J. Tsoka-Gwegweni, P. Lenkabula, P. Chikobvu

Capacity development of research ethics committees is generally limited to members, and seldom includes administrators. This study sought to map the capacity development efforts of research ethics administrators. A scoping review was conducted. The literature search yielded 92 potentially relevant records, and further screening yielded 22 studies. The 22 studies were extracted and synthesized; two studies spoke directly on administrators’ capacity development, while the remaining 20 focused on the capacity development of committees or of committee members. The two studies which spoke directly on administrators reported about two capacity development efforts targeting administrators in Africa, namely the African Conference for Administrators of Research Ethics Committees, and the West African Bioethics Training Program.

科研伦理委员会的能力建设一般限于委员，很少包括管理人员。本研究试图绘制研究伦理管理人员能力发展工作的地图。进行了范围审查。文献检索产生了92个可能相关的记录，进一步筛选产生了22个研究。提取合成22项研究;两项研究直接谈到行政人员的能力发展，其余20项研究侧重于委员会或委员会成员的能力发展。这两项研究直接谈到了管理人员，报告了针对非洲管理人员的两项能力发展努力，即非洲研究伦理委员会管理人员会议和西非生物伦理培训计划。

引用次数: 0

Assessing the Quality and Performance of Institutional Review Boards: Impact of the Revised Common Rule 评估机构审查委员会的质量和业绩：经修订的共同规则的影响

IF 1.3 4区哲学 Q2 ETHICS

Journal of Empirical Research on Human Research Ethics

Pub Date : 2022-04-26 DOI: 10.1177/15562646221094407

M. Tsan, Hannah Van Hook

The Common Rule, revised extensively to enhance human subjects protections and to reduce burdens to investigators and institutional review boards (IRBs), was implemented on January 19, 2019. We analyzed IRB performance metric data from 2016 through 2021 to evaluate the potential impact of the revised Common Rule on the quality and performance of IRBs. From 2016 to 2021, exempt protocols increased by 159% and protocols requiring IRB continuing reviews decreased by 28%. As only 48% of all protocols in 2021 were subjected to the revised Common Rule requirements, numbers of exempt protocols and protocols requiring IRB continuing reviews will continue to increase and decrease, respectively, in the next few years. Among a total of 16 IRB performance metrics studied, 4 improved, 4 deteriorated, and 8 remained unchanged from 2016 through 2021. This study represents the first effort to evaluate the impact of revised Common rule on IRB quality and performance.

《共同规则》于2019年1月19日实施，该规则进行了广泛修订，以加强对受试者的保护，减轻调查人员和机构审查委员会（IRB）的负担。我们分析了2016年至2021年的IRB绩效指标数据，以评估修订后的通用规则对IRB质量和绩效的潜在影响。从2016年到2021年，豁免协议增加了159%，需要IRB持续审查的协议减少了28%。由于2021年只有48%的协议符合修订后的共同规则要求，因此在未来几年，豁免协议和需要IRB持续审查的协议的数量将分别继续增加和减少。在总共研究的16个IRB绩效指标中，从2016年到2021年，有4个指标改善，4个指标恶化，8个指标保持不变。这项研究首次评估了修订后的通用规则对IRB质量和性能的影响。

引用次数: 1

Practicalities of Impracticability: An Interim Review of Randomized Controlled Trials 不切实际的可行性:随机对照试验的中期回顾

IF 1.3 4区哲学 Q2 ETHICS

Journal of Empirical Research on Human Research Ethics

Pub Date : 2022-04-19 DOI: 10.1177/15562646221092663

Roma Dhamanaskar, W. Feldman, J. Merz

Impracticability is an ethical standard for waiver of informed consent in research. We examine how well the criterion of impracticability appears to have been fulfilled in a set of 36 completed randomized controlled trials (RCTs) that secured consent from some subjects or LARs and employed waivers to enroll others. These trials were identified among 155 RCTs using waivers of consent in a convenience sample drawn from 7 systematic reviews. Recruitment data were available for 19 of the 36 trials, revealing an average of 41.6% of subjects (range 0.2–98.7%, 95% CI: 24.8–58.4%) were enrolled without consent. Six trials enrolled less than 10% of subjects without consent and an overlapping set of 9 trials sought consent from all subjects or LARs at some sites while waiving consent at other sites. We question whether these trials were practicable without waivers and identify issues for consideration by investigators and ethics review boards.

不可行性是研究中放弃知情同意的伦理标准。我们在一组36个已完成的随机对照试验(RCTs)中检验了不可行的标准在多大程度上得到了满足，这些试验获得了一些受试者或LARs的同意，并使用了豁免来招募其他人。这些试验是在155项随机对照试验中确定的，这些随机对照试验使用了从7个系统评价中抽取的方便样本的同意弃权。36项试验中有19项的招募数据可用，显示平均41.6%的受试者(范围0.2-98.7%，95% CI: 24.8-58.4%)未经同意入组。6项试验在未经同意的情况下招募了不到10%的受试者，9项重叠试验在某些地点寻求所有受试者或LARs的同意，而在其他地点放弃同意。我们质疑这些试验在没有豁免的情况下是否可行，并确定供研究者和伦理审查委员会考虑的问题。

引用次数: 1

International Regulatory Standards for the Qualitative Measurement of Deep Brain Stimulation in Clinical Research 临床研究中脑深部刺激定性测量的国际监管标准

IF 1.3 4区哲学 Q2 ETHICS

Journal of Empirical Research on Human Research Ethics

Pub Date : 2022-04-14 DOI: 10.1177/15562646221094922

I. Stevens, F. Gilbert

Deep brain stimulation (DBS) has progressed to become a promising treatment modality for neurologic and psychiatric disorders like epilepsy and major depressive disorder due to its growing personalization. Despite evidence pointing to the benefits of DBS if tested on these personalized qualitative metrics, rather than randomized-control trial quantitative standards, the evaluation of these novel devices appears to be based on the latter. This study surveyed the presence of this trend in the national regulatory guidelines of the prominent DBS researching countries. It was found that two governing bodies, in the European Union and Australia, acknowledged the option for qualitative measures. These findings support further development of national regulatory guidelines, so the neuroscientific community developing these neurotechnologies can better understand the impact their treatments have on patients.

脑深部刺激（DBS）由于其日益个性化，已发展成为一种治疗癫痫和重性抑郁症等神经和精神疾病的有前途的治疗方式。尽管有证据表明，如果在这些个性化的定性指标而不是随机对照试验的定量标准上进行测试，DBS的益处，但对这些新型设备的评估似乎是基于后者。本研究调查了DBS主要研究国家的国家监管指南中存在的这一趋势。调查发现，欧洲联盟和澳大利亚的两个理事机构承认可以选择采取质量措施。这些发现支持国家监管指南的进一步发展，因此开发这些神经技术的神经科学界可以更好地了解其治疗对患者的影响。

引用次数: 2

The Multidimensional Nature of Research Ethics: Letters Issued by a French Research Ethics Committee Included Similar Proportions of Ethical and Scientific Queries 研究伦理的多维性质:法国研究伦理委员会发布的信件包括相似比例的伦理和科学问题

IF 1.3 4区哲学 Q2 ETHICS

Journal of Empirical Research on Human Research Ethics

Pub Date : 2022-04-13 DOI: 10.1177/15562646221093218

T. Haaser, V. Bouteloup, D. Berdaï, M. Saux

Debate is ongoing concerning the activities and functioning of Research Ethics Committees (REC), especially a possible science-or-ethics dichotomy in research ethics review. We retrospectively analyzed 145 letters issued by a French REC over 18 months. All queries were classified in three levels: qualification (definition of the problem), category (aggregation of broader topics) and finally fields (ethical, scientific, or administrative). Overall, 971 queries were identified, of which 407 (42%), 379 (39%), and 135 (14%) were deemed ethical, scientific, and administrative queries, respectively. The most frequent concern was about participants’ information. The main influencing factor was the profession of the reporting readers—scientific queries were more frequently raised by a methodologist, whereas ethical queries were more frequently raised by an ethicist. These results indicate that research ethics review is a multidimensional task that should be considered a collaborative effort.

关于研究伦理委员会（REC）的活动和运作，特别是研究伦理审查中可能存在的科学或伦理二分法，目前正在进行辩论。我们回顾性分析了法国REC在18个月内发出的145封信件。所有问题都分为三个级别：资格（问题的定义）、类别（更广泛主题的集合），最后是领域（伦理、科学或行政）。总体而言，共发现971个查询，其中407个（42%）、379个（39%）和135个（14%）分别被视为道德、科学和行政查询。最常见的问题是参与者的信息。主要的影响因素是报道读者的职业——科学问题更频繁地由方法学家提出，而伦理问题更经常地由伦理学家提出。这些结果表明，研究伦理审查是一项多层面的任务，应该被视为一项合作努力。

引用次数: 0

How do Research Ethics Committee Members Respond to Hypothetical Studies with Children? Results from the MESSI Study 研究伦理委员会成员如何应对儿童的假设研究？MESSI研究结果

IF 1.3 4区哲学 Q2 ETHICS

Journal of Empirical Research on Human Research Ethics

Pub Date : 2022-03-18 DOI: 10.1177/15562646221087530

S. Taplin, J. Chalmers, Judith Brown, Tim Moore, Anne Graham, M. McArthur

Hypothetical scenarios were used to assess the influence of the sensitivity of the study topic, payments, and study methods on research ethics committee (HREC) members’ approval of social research studies involving children. A total of 183 Australian HREC members completed an online survey. The higher the perceived sensitivity of the study topic, the less likely the study would be approved by an HREC member. HREC members were most likely to approve each of the hypothetical studies if no payment was offered. Payment was the most common reason for not approving the low risk studies, while risks were the most common reasons for not approving the more sensitive studies. Face-to-face interviews conducted at home with children elicited substantially higher rates of approval from HREC members with more sensitive study topics. Both HRECs and researchers may benefit from additional guidance on managing risks and payments for children and young people in research.

假设情景用于评估研究主题、付款和研究方法的敏感性对研究伦理委员会（HREC）成员批准涉及儿童的社会研究的影响。共有183名澳大利亚人权委员会成员完成了一项在线调查。研究主题的敏感性越高，该研究获得人权委员会成员批准的可能性就越小。如果没有付款，人权委员会成员最有可能批准每项假设研究。付款是不批准低风险研究的最常见原因，而风险是不批准更敏感研究的最常用原因。在家中对儿童进行的面对面访谈在更敏感的研究主题上获得了人权委员会成员的更高支持率。HREC和研究人员都可能受益于研究中关于管理儿童和年轻人风险和付款的额外指导。

引用次数: 3

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全部化学•材料生命科学医学物理工程技术环境•农林材料科学地球科学法学管理学化学环境科学与生态学计算机科学教育学经济学农林科学人文科学生物学数学物理与天体物理心理学综合性期刊其他工业工程理学历史学农学文学信息工程

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Journal of Empirical Research on Human Research Ethics

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