Journal of Empirical Research on Human Research Ethics最新文献

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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

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 Q2 ETHICS

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。

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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 Q2 ETHICS

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 Q2 ETHICS

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

Stakeholder Perspectives on Returning Nonactionable Apolipoprotein L1 (APOL1) Genetic Results to African American Research Participants. 向非裔美国人研究参与者返回不可操作的载脂蛋白L1 (APOL1)遗传结果的利益相关者观点

IF 1.3 4区哲学 Q2 ETHICS

Journal of Empirical Research on Human Research Ethics

Pub Date : 2022-02-01 Epub Date: 2021-12-06 DOI: 10.1177/15562646211063267

Kathleen M West, Kerri L Cavanaugh, Erika Blacksher, Stephanie M Fullerton, Ebele M Umeukeje, Bessie Young, Wylie Burke

The ethics of returning nonactionable genetic research results to individuals are unclear. Apolipoprotein L1 (APOL1) genetic variants are nonactionable, predominantly found in people of West African ancestry, and contribute to kidney disease disparities. To inform ethical research practice, we interviewed researchers, clinicians, and African American community members (n = 76) about the potential risks and benefits of returning APOL1 research results. Stakeholders strongly supported returning APOL1 results. Benefits include reciprocity for participants, community education and rebuilding trust in research, and expectation of future actionability. Risks include analytic validity, misunderstanding, psychological burdens, stigma and discrimination, and questionable resource tradeoffs.

Conclusions:APOL1 results should be offered to participants. Responsibly fulfilling this offer requires careful identification of best communication practices, broader education about the topic, and ongoing community engagement.

将不可操作的基因研究结果返还给个人是否合乎伦理尚不清楚。载脂蛋白L1 (APOL1)遗传变异是不可操作的，主要存在于西非血统的人群中，并导致肾脏疾病的差异。为了告知伦理研究实践，我们采访了研究人员、临床医生和非裔美国人社区成员(n = 76)，了解返回APOL1研究结果的潜在风险和益处。涉众强烈支持返回APOL1结果。好处包括参与者的互惠，社区教育和重建对研究的信任，以及对未来可操作性的期望。风险包括分析有效性、误解、心理负担、污名化和歧视，以及可疑的资源权衡。结论:APOL1结果应提供给受试者。负责任地履行这一承诺需要仔细确定最佳沟通实践，就这一主题进行更广泛的教育，以及持续的社区参与。

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引用次数: 1

Reactions to Laboratory-Based Trauma Research in a Sample of Incarcerated Women. 以被监禁妇女为样本的实验室创伤研究的反应。

IF 1.3 4区哲学 Q2 ETHICS

Journal of Empirical Research on Human Research Ethics

Pub Date : 2022-02-01 Epub Date: 2021-09-20 DOI: 10.1177/15562646211043632

Steven R Lawyer, Kathleen Smith, Beena Thomas, Shelby Pemberton

An evidence-based approach to research ethics is critical to ethical research but little is known about how trauma survivors-especially those from vulnerable populations-respond to laboratory-based trauma research. One hundred four incarcerated women (N = 64 rape survivors) reported their traumatic life experiences, listened to and responded to an audio recording of a dating interaction that culminates in a completed rape, and then reported their responses to their participation. Compared to the control group (N = 40), rape survivors (N = 64) had more posttraumatic stress disorder symptoms and these symptoms were associated with more emotional responding. Both groups showed a positive benefit-cost ratio with regard to their participation did not differ on their overall reactions to research participation. These findings suggest that laboratory-based trauma research methods are associated with consistently positive experiences, which can help inform researchers and institutional review boards about the risks and benefits of such research.

以证据为基础的研究伦理方法对伦理研究至关重要，但对于创伤幸存者——尤其是那些来自弱势群体的幸存者——如何应对以实验室为基础的创伤研究，我们知之甚少。104名被监禁的妇女(N = 64名强奸幸存者)报告了她们的创伤性生活经历，听了一段约会互动的录音，并对录音做出了回应，录音的高潮是一场完整的强奸，然后报告了她们对参与的反应。与对照组(N = 40)相比，强奸幸存者(N = 64)有更多的创伤后应激障碍症状，这些症状与更多的情绪反应相关。两组在参与研究的总体反应上都表现出积极的效益-成本比。这些发现表明，以实验室为基础的创伤研究方法与始终如一的积极体验有关，这可以帮助研究人员和机构审查委员会了解此类研究的风险和益处。

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