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Understanding Constraints and Enablers of Turnaround Time for Ethics Review: The Case of Institutional Review Boards in Tanzania. 理解伦理审查周转时间的制约因素和推动因素:坦桑尼亚机构审查委员会的案例。
IF 1.3 4区 哲学 Q2 ETHICS Pub Date : 2021-12-01 Epub Date: 2021-06-28 DOI: 10.1177/15562646211026855
Mwifadhi Mrisho, Zaynab Essack

Background. Independent ethics review of research is required prior to the implementation of all health research involving human participants. However, ethics review processes are challenged by protracted turnaround times, which may negatively impact the implementation of socially valuable research. Previous research has documented delays in ethics review in developed and developing countries. This study aimed to determine the extent of variability in turnaround times for protocol review among different institutional review boards (IRBs) within Tanzania. Methods. This descriptive cross-sectional study employed a mixed-method approach, with qualitative and quantitative components. Seven IRBs were purposively sampled from the 15 accredited IRBs operational in Tanzania during the study period, April 2017-April 2018. Quantitative data were analysed using STATA software and qualitative data were analysed thematically. Results. The median time for review across all IRBs was 32 days, with a range of 1-396 days. Qualitative results identified five key themes related to turnaround time from interviews with participants. These included: (1) procedures for receiving and distribution of protocols, (2) number of reviewers assigned to protocols, (3) duration of reviewing protocols, (4) reasons for delayed feedback, and (5) training of research ethics committee members. Conclusion. The study showed that the median days for ethical approval in Tanzania was 32 days. We observed from this study that electronic submission systems facilitated faster turnaround times. Failure to adhere to the submission checklists and guidelines was a major obstacle to the turnaround time.

背景在实施所有涉及人类参与者的健康研究之前,需要对研究进行独立的伦理审查。然而,伦理审查过程面临着漫长的周转时间的挑战,这可能会对社会价值研究的实施产生负面影响。先前的研究记录了发达国家和发展中国家在伦理审查方面的延误。本研究旨在确定坦桑尼亚不同机构审查委员会(IRB)之间方案审查周转时间的可变性程度。方法。这项描述性横断面研究采用了定性和定量相结合的混合方法。在2017年4月至2018年4月的研究期间,从坦桑尼亚运营的15家经认证的IRB中抽取了7家IRB。使用STATA软件对定量数据进行分析,并对定性数据进行专题分析。后果所有IRB的审查中位时间为32天,范围为1-396天。定性结果从对参与者的访谈中确定了与周转时间有关的五个关键主题。其中包括:(1)方案的接收和分发程序,(2)分配给方案的审查人员数量,(3)审查方案的持续时间,(4)延迟反馈的原因,以及(5)研究伦理委员会成员的培训。结论研究表明,坦桑尼亚获得伦理批准的平均天数为32天。我们从这项研究中观察到,电子提交系统有助于加快周转时间。未能遵守提交清单和准则是周转时间的主要障碍。
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引用次数: 2
Invited Peer Commentary: Min-Fu Tsan: Improving the Quality and Performance of Institutional Review Boards in the U.S. Through Performance Measurements. 特邀同行评论:覃敏富:通过绩效评估提高美国机构审查委员会的质量和绩效。
IF 1.3 4区 哲学 Q2 ETHICS Pub Date : 2021-12-01 Epub Date: 2021-09-07 DOI: 10.1177/15562646211043782
Ryan Spellecy
Dr Tsan’s invited commentary “Improving the quality and performance of institutional review boards in the U.S. through performance measurements” should be commended for two important reasons. First, the article is based on a review of the performance measurement data literature on IRBs, thus grounding the discussion in the empirical evidence. There is a welcome trend in the IRB literature to see a focus on empirical research on IRBs (when the question being asked is empirical in nature), led by JERHRE and continued by this article. I welcome work such as this, and I would hope our field would as well. Second, the author should be commended for focusing not merely on turn-around time, but on other measures of quality as well. For too long, the single measure of IRB quality has been turn-around time. While this is certainly important, and we ought not lose sight of it, seeking to reduce turn-around time whenever possible, it is not the sole measure of quality for IRBs. The Coast IRB scandal, in which a commercial IRB was exposed by the Government Accountability Office for approving fake, risky studies with fictitious PIs, is a clear reminder that turn-around time alone cannot account for the quality of an IRB (Dove, 2009). Regardless of turn-around time, Coast IRB was far from a quality IRB in part because it failed to meet some of the very quality recommendations made in this article. Yet, turn-around time is important, and not simply to approve studies faster. It matters, and is related to the IRB mission, as it facilitates adherence to the Belmont ethical principles. If IRBs do not work to improve the time it takes to review and approve studies, we fail to live up to respect for persons and justice. If we believe that prospective research participants have the right to decide for themselves whether or not to participate in research, as respect for persons requires, delays in the review and approval of research will mean that some individuals will miss that chance because the research was approved too late. So too for justice, in that if we believe that research requires a fair distribution of the benefits and burdens of research, delays will slow efforts to address healthcare and research inequalities through research. Yet, we must emphasize that the IRB is tasked with reviewing and approving research, not simply expediting to reduce turnaround time. That is an essential point made by the author of this article, focusing on how the quality and efficiency of IRBs can be improved. The importance of looking to measures of quality beyond mere turn-around time relates to the question of what the role of an IRB is, or what is its mission. While many would say it is to protect research participants, including OHRP, FDA, and the regulations that govern research, I have argued elsewhere that this view is short-sighted and over focuses on non-maleficence, perhaps at the expense of other Belmont principles such as respect for persons and justice (Spellecy
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引用次数: 0
Improving the Quality and Performance of Institutional Review Boards in the U.S.A. Through Performance Measurements. 通过绩效评估提高美国院校审查委员会的质量和绩效。
IF 1.3 4区 哲学 Q2 ETHICS Pub Date : 2021-12-01 Epub Date: 2021-05-14 DOI: 10.1177/15562646211018665
Min-Fu Tsan

Performance measurement leads to quality improvement, because performance measurement can identify areas of vulnerability to guide quality improvement activities. Recommendations from empirical institutional review board (IRB) performance measurement data on research approval criteria, expedited review protocols, exempt protocols, and IRB continuing review requirements published over the past 10 years are reviewed here to improve the quality and efficiency of IRBs. Implementation of these recommendations should result in improvements that can be evaluated by follow-up performance measurements.

性能度量导致质量改进,因为性能度量可以识别易受攻击的区域,从而指导质量改进活动。本文回顾了过去10年来机构审查委员会(IRB)关于研究批准标准、加速审查方案、豁免方案和IRB持续审查要求的绩效测量数据的建议,以提高IRB的质量和效率。这些建议的实施应会带来改进,这些改进可通过后续绩效测量加以评价。
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引用次数: 2
Corrigendum to 'Using the Emanuel Framework to Explore the Ethical Issues Raised in a Participatory Visual Research Project in Rural South Africa'. “使用伊曼纽尔框架探索南非农村参与式视觉研究项目中提出的伦理问题”的勘误表。
IF 1.3 4区 哲学 Q2 ETHICS Pub Date : 2021-12-01 Epub Date: 2021-08-30 DOI: 10.1177/15562646211040281
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引用次数: 0
Challenges in the Ethical Review of Clinical and Biomedical Research in Malaysia: A Mixed Methods Study. 马来西亚临床和生物医学研究伦理审查的挑战:一项混合方法研究。
IF 1.3 4区 哲学 Q2 ETHICS Pub Date : 2021-12-01 Epub Date: 2021-07-22 DOI: 10.1177/15562646211033191
Hooi Y See, Mohd S Mohamed, Siti N M Nor, Wah Y Low

Empirical evidence of the ethical review of clinical and biomedical research in Malaysia is limited. We have conducted a convergent mixed methods research, which comprises an online survey and semistructured interviews to examine the challenges in the ethical review of clinical and biomedical research. Data collected reveal that the ethics review process is inconsistent, duplicate, and inadequate. The results indicate a strong need for a centralized ethical review mechanism and a national system for mutual recognition of ethics reviews to improve the effectiveness and efficiency of the ethics review system in Malaysia. A joint research ethics committee review between Malaysia and sponsoring countries for multinational research should also be encouraged as it could address the concerns of the lack of expertise and training.

马来西亚临床和生物医学研究伦理审查的经验证据有限。我们进行了一项融合混合方法研究,其中包括在线调查和半结构化访谈,以检查临床和生物医学研究伦理审查中的挑战。收集的数据显示,伦理审查过程不一致、重复和不充分。研究结果表明,马来西亚迫切需要建立一个集中的伦理审查机制和一个全国性的伦理审查互认制度,以提高伦理审查制度的有效性和效率。马来西亚和多国研究资助国之间的联合研究伦理委员会审查也应该得到鼓励,因为它可以解决缺乏专业知识和培训的问题。
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引用次数: 1
Use of Template Documents with Guidance to Improve the Quality of Human Subjects Research Protocol Submissions to a Thai Research Ethics Committee. 使用模板文件与指导提高人类受试者研究方案提交给泰国研究伦理委员会的质量。
IF 1.3 4区 哲学 Q2 ETHICS Pub Date : 2021-12-01 Epub Date: 2021-06-14 DOI: 10.1177/15562646211025470
Thana Khawcharoenporn, Wilaiwan Chimkhong, Varanya Roestpricha

A pre-post study was conducted to evaluate the utility of template documents specifically created to assist research protocol submissions to a Thai research ethics committee (REC). A total of 172 protocols during the 2014-2016 preintervention period were matched to 172 protocols during the 2017-2019 postintervention period by type of principal investigator and REC review category. The intervention was associated with a significant reduction in initial REC requirement deficiencies in the information sheet and informed consent form, resubmission turn-around time by the principal investigator, and time form protocol submission to REC approval. The most significant postintervention improvements were for information about the consent process and listed risks of study participation. In this study, utilization of a structured protocol template with guidance instructions was associated with measurable improvement in the quality of research protocol submissions and REC review process.

进行了一项前后研究,以评估专门为协助向泰国研究伦理委员会(REC)提交研究方案而创建的模板文件的效用。根据主要研究者类型和REC审查类别,将2014-2016年干预前期间的172项方案与2017-2019年干预后期间的172项方案进行匹配。干预与信息表和知情同意书中初始REC要求缺陷的显著减少、主要研究者重新提交的周转时间以及方案提交到REC批准的时间有关。干预后最显著的改进是关于同意过程的信息和参与研究的风险列表。在本研究中,使用带有指导说明的结构化方案模板与研究方案提交和REC审查过程质量的可测量改善相关。
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引用次数: 0
Path Analysis of RCT Recruitment: Secondary Analysis of Results from a Systematic Review. 随机对照试验招募的路径分析:系统评价结果的二次分析。
IF 1.3 4区 哲学 Q2 ETHICS Pub Date : 2021-10-01 Epub Date: 2021-06-09 DOI: 10.1177/15562646211023698
Nicole Jochym, Lisa Y Lin, Jon F Merz

We examine recruitment processes for 71 pragmatic and comparative effectiveness trials identified in a systematic review, using path analysis to examine rates of refusal to screen, test, and consent to trial participation. Our analysis suggests that refusal rates might be on net slightly higher if potential subjects are screened or asked to undergo physical eligibility tests, but this was not significant in our sample of trials (p = .11 by Mann-Whitney test). We find that rates of refusing to provide informed consent are much lower for trials in which subjects have agreed to screening or testing (odds ratio = 0.40, Wilcoxon rank-sum z = 2.67, p = .008). We also observe that the overwhelming majority of trials examined secured consent after determining eligibility, even in trials involving screening or testing activities. The ethical implications and areas for future research are discussed.

我们检查了系统评价中确定的71项实用和比较有效性试验的招募过程,使用通径分析来检查拒绝筛选、测试和同意参加试验的比率。我们的分析表明,如果对潜在的受试者进行筛选或要求进行身体资格测试,拒绝率可能会略高,但这在我们的试验样本中并不显著(p =)。曼-惠特尼试验)。我们发现,在受试者同意筛查或测试的试验中,拒绝提供知情同意的比率要低得多(优势比= 0.40,Wilcoxon秩和z = 2.67, p = 0.008)。我们还观察到,即使在涉及筛选或测试活动的试验中,绝大多数试验在确定资格后审查了获得同意的情况。讨论了未来研究的伦理意义和领域。
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引用次数: 0
Survey on the Research Misconduct and Questionable Research Practices of Medical Students, PhD Students, and Supervisors at the Zagreb School of Medicine in Croatia. 克罗地亚萨格勒布医学院医学生、博士生和导师的研究不端行为和可疑研究行为调查。
IF 1.3 4区 哲学 Q2 ETHICS Pub Date : 2021-10-01 Epub Date: 2021-07-26 DOI: 10.1177/15562646211033727
Ana Marija Ljubenković, Ana Borovečki, Marko Ćurković, Bjørn Hofmann, Søren Holm

This cross-sectional study evaluates the knowledge, attitudes, experiences, and behavior of final year medical students, PhD students, and supervisors at the School of Medicine of the University of Zagreb in relation to research misconduct, questionable research practices, and the research environment. The overall response rate was 36.4% (68%-100% for the paper survey and 8%-15% for the online surveys). The analysis reveals statistically significant differences in attitude scores between PhD students and supervisors, the latter having attitudes more in concordance with accepted norms. The results overall show a nonnegligible incidence of self-reported misconduct and questionable research practices, as well as some problematic attitudes towards misconduct and questionable research practices. The incidence of problematic authorship practices was particularly high. The research environment was evaluated as being mostly supportive of research integrity.

本横断面研究评估了萨格勒布大学医学院最后一年级医学生、博士生和导师在研究不当行为、有问题的研究实践和研究环境方面的知识、态度、经验和行为。总体回复率为36.4%(纸质调查68%-100%,在线调查8%-15%)。分析显示,博士生和导师的态度得分有统计学上的显著差异,后者的态度更符合公认的规范。总体结果显示,自我报告的不当行为和有问题的研究实践的发生率不可忽视,以及对不当行为和有问题的研究实践的一些有问题的态度。有问题的作者行为的发生率特别高。研究环境被评价为最支持研究诚信。
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引用次数: 5
Digital Mega-Studies as a New Research Paradigm: Governing the Health Research of the Future. 数字大研究作为一种新的研究范式:管理未来的健康研究。
IF 1.3 4区 哲学 Q2 ETHICS Pub Date : 2021-10-01 Epub Date: 2021-09-09 DOI: 10.1177/15562646211041492
Jessica Bell, Megan Prictor, Lauren Davenport, Lynda O'Brien, Melissa Wake

'Digital Mega-Studies' are entirely or extensively digitised, longitudinal, population-scale initiatives, collecting, storing, and making available individual-level research data of different types and from multiple sources, shaped by technological developments and unforeseeable risks over time. The Australian 'Gen V' project exemplifies this new research paradigm. In 2019, we undertook a multidisciplinary, multi-stakeholder process to map Digital Mega-Studies' key characteristics, legal and governance challenges and likely solutions. We conducted large and small group processes within a one-day symposium and directed online synthesis and group prioritisation over subsequent weeks. We present our methods (including elicitation, affinity mapping and prioritisation processes) and findings, proposing six priority governance principles across three areas-data, participation, trust-to support future high-quality, large-scale digital research in health.

“数字大研究”是完全或广泛数字化、纵向的、人口规模的举措,收集、存储和提供来自多个来源的不同类型的个人层面的研究数据,这些数据受到技术发展和不可预见的风险的影响。澳大利亚的“Gen V”项目就是这种新研究范式的例证。2019年,我们开展了一个多学科、多利益相关方的流程,以绘制数字大研究的主要特征、法律和治理挑战以及可能的解决方案。我们在为期一天的研讨会上进行了大型和小型小组流程,并在随后的几周内指导在线合成和小组优先排序。我们介绍了我们的方法(包括启发、亲和映射和优先排序过程)和研究结果,并在数据、参与、信任三个领域提出了六项优先治理原则,以支持未来高质量、大规模的健康数字研究。
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引用次数: 0
The Ethical Implications of Using Social Media to Engage and Retain Justice-Involved Youth in Behavioral Health Research. 在行为健康研究中使用社交媒体吸引和保留正义参与的青少年的伦理意义。
IF 1.3 4区 哲学 Q2 ETHICS Pub Date : 2021-10-01 Epub Date: 2021-09-17 DOI: 10.1177/15562646211039701
Christopher A Rodriguez, Lakshmi Gopalakrishnan, Margareth Del Cid, Johanna B Folk, Juliet Yonek, Marina Tolou-Shams

Given its popularity among youth ages 13-17, social media is a promising avenue for engaging and retaining historically hard-to-reach youth in longitudinal research. Social media use in longitudinal research involving youth, however, has preceded development of best practices for ethical use. This article describes the ethical challenges and considerations of using social media to engage and retain youth within the context of a randomized controlled trial of a group-based adolescent substance use intervention. Best practices for addressing ethical challenges are also provided using the Belmont Principle as a guiding framework. As social media becomes more commonly used to engage and retain youth in clinical research studies, researchers must address emerging ethical concerns within project protocols.

鉴于社交媒体在13-17岁青少年中的受欢迎程度,在纵向研究中,社交媒体是吸引和留住历史上难以接触的年轻人的一个很有前途的途径。然而,在涉及青少年的纵向研究中,社交媒体的使用先于道德使用的最佳实践的发展。本文描述了在一项基于群体的青少年药物使用干预的随机对照试验的背景下,使用社交媒体吸引和留住青少年的伦理挑战和考虑因素。以贝尔蒙特原则为指导框架,提供了应对道德挑战的最佳实践。随着社交媒体越来越普遍地用于吸引和留住年轻人参与临床研究,研究人员必须在项目协议中解决新出现的伦理问题。
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引用次数: 2
期刊
Journal of Empirical Research on Human Research Ethics
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