Journal of Empirical Research on Human Research Ethics最新文献

英文中文

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 Q1 Social Sciences

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 Q1 Social Sciences

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 Q1 Social Sciences

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 Q1 Social Sciences

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 Q1 Social Sciences

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 Q1 Social Sciences

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 Q1 Social Sciences

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

Preliminary Evidence for an Association between Journal Submission Requirements and Reproducibility of Published Findings: A Pilot Study 期刊提交要求与已发表研究结果再现性之间关联的初步证据：一项试点研究

IF 1.3 4区哲学 Q1 Social Sciences

Journal of Empirical Research on Human Research Ethics

Pub Date : 2022-02-28 DOI: 10.1177/15562646221083384

Mitch Brown, R. McGrath, D. Sacco

Systemic efforts have been employed to improve the reproducibility of published findings in psychology. To date, little research has been conducted evaluating how well these efforts work. In an effort to bridge this gap, the current study looked at journal submission requirements intended to encourage authors to engage in best practices for facilitating reproducible science and offers preliminary evidence for their potential efficacy. We calculated reproducibility indices (p-curves) for three randomly selected empirical studies published in each of 23 psychology journals in 2019 and correlated quantitative results from those analyzes with the number of submission requirements for each journal that intended to ensure compliance with best reporting practices. Results indicated a greater number of submission requirements at a given outlet was associated with indices indicating greater likelihood of reproducibility of findings. We frame findings as impetus for future, more extensive, research to identify causal links between submission requirements and reproducibility.

为了提高心理学研究成果的可重复性，已经进行了系统的努力。迄今为止，很少有研究评估这些努力的效果。为了弥补这一差距，目前的研究着眼于期刊提交要求，旨在鼓励作者参与促进可复制科学的最佳实践，并为其潜在功效提供初步证据。我们计算了2019年在23本心理学期刊中每一本上随机选择的三项实证研究的再现性指数（p曲线），并将这些分析的定量结果与每一本期刊的提交要求数量相关联，以确保符合最佳报告实践。结果表明，在给定的网点，更多的提交要求与表明调查结果再现性可能性更大的指数相关。我们将研究结果视为未来更广泛研究的动力，以确定提交要求和再现性之间的因果关系。

{"title":"Preliminary Evidence for an Association between Journal Submission Requirements and Reproducibility of Published Findings: A Pilot Study","authors":"Mitch Brown, R. McGrath, D. Sacco","doi":"10.1177/15562646221083384","DOIUrl":"https://doi.org/10.1177/15562646221083384","url":null,"abstract":"Systemic efforts have been employed to improve the reproducibility of published findings in psychology. To date, little research has been conducted evaluating how well these efforts work. In an effort to bridge this gap, the current study looked at journal submission requirements intended to encourage authors to engage in best practices for facilitating reproducible science and offers preliminary evidence for their potential efficacy. We calculated reproducibility indices (p-curves) for three randomly selected empirical studies published in each of 23 psychology journals in 2019 and correlated quantitative results from those analyzes with the number of submission requirements for each journal that intended to ensure compliance with best reporting practices. Results indicated a greater number of submission requirements at a given outlet was associated with indices indicating greater likelihood of reproducibility of findings. We frame findings as impetus for future, more extensive, research to identify causal links between submission requirements and reproducibility.","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2022-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47877317","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Research Ethics Consultation in Nursing Studies. 护理研究中的研究伦理咨询。

IF 1.3 4区哲学 Q1 Social Sciences

Journal of Empirical Research on Human Research Ethics

Pub Date : 2022-02-01 Epub Date: 2021-08-10 DOI: 10.1177/15562646211036577

Chikako Kane, Satoshi Sakaguchi, Masayuki Chuma, Kenta Yagi, Kenshi Takechi, Yuki Aoe, Tomoko Takagai, Hiroaki Yanagawa

Despite the importance and acceptance of research ethics consultation as an entity in many medical research areas, little is known about its status in nursing research. Focusing on inquiries from nurse researchers, we retrospectively analyzed records of integrated clinical research consultation, provided by members of the Clinical Research Center independently of the research ethics committee, at a Japanese university hospital during 2018-2019. Among various consultations in nursing studies (n = 101), 43 were related to research ethics. The main issues in research ethics consultation were compatibility with guidelines (n = 28; 65%) and application of ethics review (n = 12; 28%). Future studies should investigate international settings and address the relevance of research ethics consultation to promote proper nursing studies.

尽管研究伦理咨询作为一个实体在许多医学研究领域的重要性和接受度，但对其在护理研究中的地位知之甚少。以护士研究人员的询问为重点，我们回顾性分析了2018-2019年日本某大学医院独立于研究伦理委员会的临床研究中心成员提供的综合临床研究咨询记录。在护理研究的各种咨询(n = 101)中，43例与研究伦理有关。研究伦理咨询的主要问题是与指南的兼容性(n = 28;65%)和伦理审查的应用(n = 12;28%)。未来的研究应探讨国际环境和研究伦理咨询的相关性，以促进适当的护理研究。

引用次数: 2

The Challenges of Big Data for Research Ethics Committees: A Qualitative Swiss Study. 大数据对研究伦理委员会的挑战:一项定性的瑞士研究。

IF 1.3 4区哲学 Q1 Social Sciences

Journal of Empirical Research on Human Research Ethics

Pub Date : 2022-02-01 Epub Date: 2021-11-15 DOI: 10.1177/15562646211053538

Agata Ferretti, Marcello Ienca, Minerva Rivas Velarde, Samia Hurst, Effy Vayena

Big data trends in health research challenge the oversight mechanism of the Research Ethics Committees (RECs). The traditional standards of research quality and the mandate of RECs illuminate deficits in facing the computational complexity, methodological novelty, and limited auditability of these approaches. To better understand the challenges facing RECs, we explored the perspectives and attitudes of the members of the seven Swiss Cantonal RECs via semi-structured qualitative interviews. Our interviews reveal limited experience among REC members with the review of big data research, insufficient expertise in data science, and uncertainty about how to mitigate big data research risks. Nonetheless, RECs could strengthen their oversight by training in data science and big data ethics, complementing their role with external experts and ad hoc boards, and introducing precise shared practices.

卫生研究中的大数据趋势对研究伦理委员会(rec)的监督机制提出了挑战。传统的研究质量标准和RECs的任务说明了这些方法在面对计算复杂性、方法新颖性和有限可审计性方面的缺陷。为了更好地了解RECs面临的挑战，我们通过半结构化定性访谈探讨了七个瑞士州RECs成员的观点和态度。我们的访谈显示，REC成员在大数据研究方面的经验有限，在数据科学方面的专业知识不足，以及如何减轻大数据研究风险的不确定性。尽管如此，RECs可以通过数据科学和大数据伦理方面的培训来加强监督，与外部专家和特设委员会互补，并引入精确的共享实践。

引用次数: 15

首页上一页

下一页尾页

类型

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

数据库

全部 ACS Publications Elsevier ieeexplore Springer The Royal Society of Chemistry Wiley

期刊

Journal of Empirical Research on Human Research Ethics

全部 Acc. Chem. Res. ACS Applied Bio Materials ACS Appl. Electron. Mater. ACS Appl. Energy Mater. ACS Appl. Mater. Interfaces ACS Appl. Nano Mater. ACS Appl. Polym. Mater. ACS BIOMATER-SCI ENG ACS Catal. ACS Cent. Sci. ACS Chem. Biol. ACS Chemical Health & Safety ACS Chem. Neurosci. ACS Comb. Sci. ACS Earth Space Chem. ACS Energy Lett. ACS Infect. Dis. ACS Macro Lett. ACS Mater. Lett. ACS Med. Chem. Lett. ACS Nano ACS Omega ACS Photonics ACS Sens. ACS Sustainable Chem. Eng. ACS Synth. Biol. Anal. Chem. BIOCHEMISTRY-US Bioconjugate Chem. BIOMACROMOLECULES Chem. Res. Toxicol. Chem. Rev. Chem. Mater. CRYST GROWTH DES ENERG FUEL Environ. Sci. Technol. Environ. Sci. Technol. Lett. Eur. J. Inorg. Chem. IND ENG CHEM RES Inorg. Chem. J. Agric. Food. Chem. J. Chem. Eng. Data J. Chem. Educ. J. Chem. Inf. Model. J. Chem. Theory Comput. J. Med. Chem. J. Nat. Prod. J PROTEOME RES J. Am. Chem. Soc. LANGMUIR MACROMOLECULES Mol. Pharmaceutics Nano Lett. Org. Lett. ORG PROCESS RES DEV ORGANOMETALLICS J. Org. Chem. J. Phys. Chem. J. Phys. Chem. A J. Phys. Chem. B J. Phys. Chem. C J. Phys. Chem. Lett. Analyst Anal. Methods Biomater. Sci. Catal. Sci. Technol. Chem. Commun. Chem. Soc. Rev. CHEM EDUC RES PRACT CRYSTENGCOMM Dalton Trans. Energy Environ. Sci. ENVIRON SCI-NANO ENVIRON SCI-PROC IMP ENVIRON SCI-WAT RES Faraday Discuss. Food Funct. Green Chem. Inorg. Chem. Front. Integr. Biol. J. Anal. At. Spectrom. J. Mater. Chem. A J. Mater. Chem. B J. Mater. Chem. C Lab Chip Mater. Chem. Front. Mater. Horiz. MEDCHEMCOMM Metallomics Mol. Biosyst. Mol. Syst. Des. Eng. Nanoscale Nanoscale Horiz. Nat. Prod. Rep. New J. Chem. Org. Biomol. Chem. Org. Chem. Front. PHOTOCH PHOTOBIO SCI PCCP Polym. Chem.

﹀