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Assessing the Decision-Making Capabilities of Artificial Intelligence Platforms as Institutional Review Board Members. 评估人工智能平台作为机构审查委员会成员的决策能力。
IF 1.7 4区 哲学 Q2 ETHICS Pub Date : 2024-07-01 Epub Date: 2024-06-17 DOI: 10.1177/15562646241263200
Kannan Sridharan, Gowri Sivaramakrishnan

Background: Institutional review boards (IRBs) face delays in reviewing research proposals, underscoring the need for optimized standard operating procedures (SOPs). This study assesses the abilities of three artificial intelligence (AI) platforms to address IRB challenges and draft essential SOPs. Methods: An observational study was conducted using three AI platforms in 10 case studies reflecting IRB functions, focusing on creating SOPs. The accuracy of the AI outputs was assessed against good clinical practice (GCP) guidelines. Results: The AI tools identified GCP issues, offered guidance on GCP violations, detected conflicts of interest and SOP deficiencies, recognized vulnerable populations, and suggested expedited review criteria. They also drafted SOPs with some differences. Conclusion: AI platforms could aid IRB decision-making and improve review efficiency. However, human oversight remains critical for ensuring the accuracy of AI-generated solutions.

背景:机构审查委员会(IRB)在审查研究提案时面临延误,这突出表明需要优化标准操作程序(SOP)。本研究评估了三种人工智能(AI)平台应对 IRB 挑战和起草基本 SOP 的能力。研究方法在 10 个反映 IRB 功能的案例研究中使用三种人工智能平台进行了观察研究,重点是创建 SOP。根据良好临床实践 (GCP) 指南对人工智能输出的准确性进行了评估。结果显示人工智能工具识别了 GCP 问题,为违反 GCP 的行为提供了指导,发现了利益冲突和 SOP 缺陷,识别了弱势人群,并提出了快速审查标准。它们起草的 SOP 也存在一些差异。结论人工智能平台可以帮助 IRB 决策并提高审查效率。然而,要确保人工智能生成的解决方案的准确性,人工监督仍然至关重要。
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引用次数: 0
Australian Attitudes Towards Waivers of Consent Within the Context of Genomic Data Sharing. 澳大利亚人对基因组数据共享背景下放弃同意的态度。
IF 1.7 4区 哲学 Q2 ETHICS Pub Date : 2024-07-01 DOI: 10.1177/15562646241261848
Lyndsay Newett, Rebekah McWhirter, Lisa Eckstein, Vanessa Warren, Dianne Nicol

This research identifies the circumstances in which Human Research Ethics Committees (HRECs) are trusted by Australians to approve the use of genomic data - without express consent - and considers the impact of genomic data sharing settings, and respondent attributes, on public trust. Survey results (N = 3013) show some circumstances are more conducive to public trust than others, with waivers endorsed when future research is beneficial and when privacy is protected, but receiving less support in other instances. Still, results imply attitudes are influenced by more than these specific circumstances, with different data sharing settings, and participant attributes, affecting views. Ultimately, this research raises questions and concerns in relation to the criteria HRECs use when authorising waivers of consent in Australia.

本研究确定了澳大利亚人信任人类研究伦理委员会(HREC)在哪些情况下批准使用基因组数据(无需明确同意),并考虑了基因组数据共享设置和受访者属性对公众信任的影响。调查结果(N = 3013)显示,某些情况比其他情况更有利于提高公众信任度,当未来研究有益和隐私受到保护时,放弃同意会得到认可,但在其他情况下,支持率较低。尽管如此,研究结果表明,影响人们态度的不仅仅是这些特定情况,不同的数据共享环境和参与者属性也会影响人们的看法。最终,这项研究提出了一些问题,并引起了人们对澳大利亚 HREC 在授权放弃同意时使用的标准的关注。
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引用次数: 0
Evaluation of a Training Program on Gender Mainstreaming in Health Research Evaluation at the Senegalese National Research Ethics Committee. 塞内加尔国家研究伦理委员会健康研究评估中的性别主流化培训项目评估。
IF 1.7 4区 哲学 Q2 ETHICS Pub Date : 2024-07-01 Epub Date: 2024-03-18 DOI: 10.1177/15562646241238816
Guillermo Z Martínez-Pérez, Carme Campoy Guerrero, Brigitte Bagnol, Samba Cor Sarr, El Hadji Mamadou Mbaye, Ousmane Diouf, El Hadji Ibrahima Touré, Viviane Mbengue, Oumy Ndiaye, Farah Nabil

Health research must be of high ethical and scientific quality and consider the needs and experiences of women, men, and nonbinary individuals. National Research Ethics Committees (RECs) are in a strategic position to impede sex- and gender-blind research. In 2020 and 2021, training programs on gender mainstreaming and sex and gender approaches in research evaluation were launched in Senegal. They were evaluated through a mixture of qualitative and quantitative methods. Knowledge acquisition was 16.67%, 8.54%, and 28.42% for the trainees of 2021, 2020, and those who attended the training in both years, respectively. Gender mainstreaming was reported as pertinent in research ethics by 74% of participants. This training is expected to catalyze gender-transformative research ethics in West Africa.

健康研究必须具有较高的伦理和科学质量,并考虑到女性、男性和非二元个体的需求和经历。国家研究伦理委员会(RECs)在阻碍无视性别和性别差异的研究方面处于战略地位。2020 年和 2021 年,塞内加尔启动了关于性别主流化以及研究评估中的性与性别方法的培训计划。通过定性和定量相结合的方法对这些计划进行了评估。2021 年、2020 年和这两年参加培训的学员的知识获取率分别为 16.67%、8.54% 和 28.42%。74% 的学员认为性别主流化与研究伦理相关。此次培训有望促进西非研究伦理的性别变革。
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引用次数: 0
Balancing Ethics and Culture: A Scoping Review of Ethico-Cultural and Implementation Challenges of the Individual-Based Consent Model in African Research. 平衡伦理与文化:关于非洲研究中基于个人的同意模式的伦理-文化和实施挑战的范围审查》。
IF 1.7 4区 哲学 Q2 ETHICS Pub Date : 2024-07-01 Epub Date: 2024-03-18 DOI: 10.1177/15562646241237669
Richard Appiah, Giuseppe Raviola, Benedict Weobong

Objective: This review explores the ethico-cultural and implementation challenges associated with the individual-based informed consent (IC) model in the relatively collectivistic African context and examines suggested approaches to manage them. Methods: We searched four databases for peer-reviewed studies published in English between 2000 to 2023 that examined the ethico-cultural and implementation challenges associated with the IC model in Africa. Results: Findings suggest that the individual-based IC model largely misaligns with certain African social values and ethos and subverts the authority and functions of community gatekeepers. Three recommendations were proffered to manage these challenges, that researchers should: adopt a multi-step approach to IC, conduct a rapid ethical assessment, and generate an African-centered IC model. Conclusions: A pluriversal, context-specific, multi-step IC model that critically harmonizes the cultural values of the local population and the general principles of IC can minimize ethics dumping, safeguard the integrity of the research process, and promote respectful engagement.

目的:本综述探讨了在相对集体主义的非洲背景下,基于个人的知情同意(IC)模式在伦理文化和实施方面所面临的挑战,并研究了应对这些挑战的建议方法。研究方法我们在四个数据库中检索了 2000 年至 2023 年间以英文发表的同行评审研究,这些研究探讨了与非洲 IC 模式相关的伦理文化和实施挑战。结果研究结果表明,以个人为基础的集成电路模式在很大程度上与非洲的某些社会价值观和伦理不一致,并颠覆了社区守门人的权威和职能。为应对这些挑战,提出了三项建议,即研究人员应:采取多步骤的集成电路方法,进行快速伦理评估,以及生成以非洲为中心的集成电路模型。结论:一个多元的、针对具体情况的、多步骤的伦理委员会模式,在批判性地协调当地人口的文化价值观和伦理委员会的一般原则的基础上,可以最大限度地减少伦理倾销,保障研究过程的完整性,并促进相互尊重的参与。
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引用次数: 0
The Ethics of Using Artificial Intelligence in Qualitative Research. 在定性研究中使用人工智能的伦理。
IF 1.7 4区 哲学 Q2 ETHICS Pub Date : 2024-07-01 Epub Date: 2024-06-17 DOI: 10.1177/15562646241262659
David T Marshall, David B Naff

Artificial Intelligence (AI) and other large language models are rapidly infiltrating the world of education and educational research. These new technological developments raise questions about use and ethics throughout the world of educational research, particularly for qualitative methods given the philosophical and structural foundations of its associated designs. This paper seeks to interrogate the perceived ethics around the use of AI in qualitative research and draws on survey data from qualitative researchers (n = 101) collected from April-May 2023. Findings indicate that researchers were more apt to embrace the use of AI for transcription purposes, and to a lesser extent for preliminary coding. Researchers from high research productivity (R1) universities were generally less accepting of AI's use in the research process than other researchers.

人工智能(AI)和其他大型语言模型正在迅速渗透到教育和教育研究领域。这些新技术的发展引发了整个教育研究领域的使用和伦理问题,特别是对定性方法而言,因为其相关设计具有哲学和结构基础。本文试图探究在定性研究中使用人工智能的伦理问题,并借鉴了 2023 年 4 月至 5 月期间收集的定性研究人员(n = 101)的调查数据。调查结果显示,研究人员更倾向于将人工智能用于转录目的,其次才是初步编码。与其他研究人员相比,来自高研究生产力(R1)大学的研究人员普遍不太接受在研究过程中使用人工智能。
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引用次数: 0
Contraception Requirements in Clinical Research Consent Forms: Assessing and Supporting Gender Inclusive Practices. 临床研究同意书中的避孕要求:评估和支持性别包容实践。
IF 1.7 4区 哲学 Q2 ETHICS Pub Date : 2024-07-01 Epub Date: 2024-03-11 DOI: 10.1177/15562646241238301
Tara Coffin, Erin Brower, Sharad Adekar

Gender-diverse individuals are underserved in clinical research settings. Reliance on gendered language throughout the consent process for clinical research contributes to the marginalization of these populations. The research objective was to assess use of gender-inclusive language used to describe the contraception requirement in consent forms. We categorized and analyzed contraception language in 289 clinical trial consent forms using a deductive and summative content analysis approach. We found that 79% (n = 227) of consent forms contained gender-inclusive language, 80% (n = 231) used terms that fell under the biological sex language, and 91% (n = 264) used gendered language. No consent forms used exclusively gender-inclusive language and the majority 63% (n = 182) featuring a combination of all three language types. There were many consent forms which would have been entirely gender-inclusive language if section headings with references to biological-sex-specific contraceptives were excluded, suggesting that gender-inclusive language may be attainable with minor revisions.

在临床研究环境中,不同性别的人得不到充分的服务。在临床研究的整个同意过程中,依赖于性别语言会导致这些人群被边缘化。我们的研究目标是评估在同意书中描述避孕要求的性别包容性语言的使用情况。我们采用演绎和总结性内容分析法对 289 份临床试验同意书中的避孕用语进行了分类和分析。我们发现,79%(n = 227)的同意书包含性别包容性语言,80%(n = 231)的同意书使用了属于生物性别语言的术语,91%(n = 264)的同意书使用了性别化语言。没有一份同意书只使用了性别包容性语言,大多数同意书的 63%(n = 182)使用了这三种语言的组合。有许多同意书如果不包括提及特定生物性别避孕药具的章节标题,就完全可以使用性别全纳语言,这表明只要稍加修改,就可以使用性别全纳语言。
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引用次数: 0
Valuing Academic Freedom and Advocacy 重视学术自由和宣传
IF 1.3 4区 哲学 Q1 Social Sciences Pub Date : 2024-04-08 DOI: 10.1177/15562646241246369
Tanya Doherty, Max Kroon, Catherine Pereira-Kotze
This is a correspondence letter in response to an article published in the journal: Flaherman VJ, Nankabirwa V, Ginsburg AS. Promoting Transparent and Equitable Discussion of Controversial Research. Journal of Empirical Research on Human Research Ethics 2023; 18(4): 248–9.
这是对杂志上发表的一篇文章的回信:Flaherman VJ, Nankabirwa V, Ginsburg AS.促进有争议研究的透明与公平讨论》。人类研究伦理实证研究期刊》2023;18(4):248-9.
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引用次数: 0
Evaluating the Decisional Capacity for Informed Consent of Transition age Children to Adolescents in Human Subject Research. 评估人类受试者研究中即将步入青春期的儿童的知情同意决策能力。
IF 1.3 4区 哲学 Q1 Social Sciences Pub Date : 2024-02-01 Epub Date: 2023-12-10 DOI: 10.1177/15562646231219384
Kamran Salayev, Ulviyya Aslanova, Kerim Munir

This study aimed to evaluate children's capacity for informed consent. We translated into Azerbaijani language and adapted the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC). We enrolled four healthy groups: children aged 11, 12, and 13 years and adults. We provided the participants with information about the simulated research proposal and a related informed consent form. Subsequently, they were administered the UBACC. The mean total UBACC scores were 11.9 (11-year-olds), 12.7 (12-year-olds), 14.0 (13-year-olds), and 16.0 (adults). The gradual increase in the mean UBACC scores with age suggests the continuous maturation of the capacity to comprehend the informed consent process. There was no specific cutoff age to decide whether the children were competent enough to provide informed consent.

本研究旨在评估儿童的知情同意能力。我们将加利福尼亚大学圣地亚哥分校的 "知情同意能力简要评估"(UBACC)翻译成阿塞拜疆语并进行了改编。我们招募了四组健康人:11、12 和 13 岁的儿童以及成人。我们向参与者提供了有关模拟研究方案的信息和相关知情同意书。随后,他们接受了 UBACC 测试。UBACC 的平均总分分别为 11.9 分(11 岁儿童)、12.7 分(12 岁儿童)、14.0 分(13 岁儿童)和 16.0 分(成人)。随着年龄的增长,UBACC 的平均分逐渐上升,这表明理解知情同意程序的能力在不断成熟。在决定儿童是否有足够能力做出知情同意时,并没有特定的截止年龄。
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引用次数: 0
Evaluation of Turkish Academic and Student Attitudes on Plagiarism: Validity and Reliability of the Plagiarism Attitudes Scale. 评估土耳其学术界和学生对剽窃行为的态度:剽窃态度量表的有效性和可靠性。
IF 1.3 4区 哲学 Q1 Social Sciences Pub Date : 2024-02-01 Epub Date: 2024-02-25 DOI: 10.1177/15562646241231597
Gamze Özbek Güven, Feyza Inceoğlu, Şerife Yilmaz, Fuat Ince

The main purpose of this study was to translate the Plagiarism Attitude Scale into Turkish and validate it for use in Turkish settings, in order to better understand research integrity attitudes and awareness of the Turkish academic and student community, while also contributing an instrument for research in this area. The research was designed and conducted with 483 participants. In the process of adapting the scale to Turkish, language, content, and construct validity analyses were performed. Following the completion of the validity phase, the reliability of the scale was examined using Cronbach's alpha coefficient and the split-half method. The results indicate that the scale's language and content validity are deemed sufficient. According to the findings of the research, the Plagiarism Attitude Scale, in its adapted Turkish version, is considered a valid and reliable tool. The use of this Turkish scale will assist local researchers in sharing their unique perspectives and help the international community better understand research ethics concerns in Türkiye. Additionally, this scale will serve as a valuable resource for planning educational programs.

本研究的主要目的是将 "剽窃态度量表 "翻译成土耳其语,并对其进行验证,以便在土耳其环境中使用,从而更好地了解土耳其学术界和学生群体的研究诚信态度和意识,同时也为该领域的研究提供一种工具。这项研究由 483 名参与者设计和实施。在将量表改编为土耳其语的过程中,进行了语言、内容和结构效度分析。在有效性分析阶段结束后,使用克朗巴赫α系数和分半法对量表的可靠性进行了检验。结果表明,量表的语言和内容效度被认为是充分的。根据研究结果,剽窃态度量表的土耳其语改编版被认为是一个有效和可靠的工具。土耳其语量表的使用将有助于当地研究人员分享他们的独特观点,并帮助国际社会更好地了解土耳其的研究伦理问题。此外,该量表还将成为规划教育计划的宝贵资源。
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引用次数: 0
Trust in Medical Research: A Comparative Study among Patients at a Regional Referral Hospital and Community Members in Lira District, Northern Uganda. 对医学研究的信任:乌干达北部利拉地区一家地区转诊医院的患者与社区成员的比较研究。
IF 1.3 4区 哲学 Q1 Social Sciences Pub Date : 2024-02-01 Epub Date: 2024-01-12 DOI: 10.1177/15562646231224374
Jafesi Pulle, Sana Loue, Gertrude N Kiwanuka, Bajunirwe Francis

Events such as the Tuskegee syphilis study shaped how the public perceives and trusts medical research globally. However, few studies have examined trust in medical research in developing countries. We tested the hypothesis that levels of trust may be lower among community members compared to hospitalized persons in Uganda. We enrolled 296 participants in rural northern Uganda, and 148(50%) were from the community, 192(65%) were female. Mean level of trust for medical research was higher among hospitalized persons compared to community members (p = 0.0001). Previous research participation (p = 0.03), and willingness to participate in future research (p = 0.001) were positively associated with trust. Medical personnel should engage more with the communities in which they practice fostering trust in medical research.

塔斯基吉梅毒研究等事件影响了全球公众对医学研究的看法和信任。然而,很少有研究考察发展中国家对医学研究的信任度。我们测试了这样一个假设:在乌干达,社区成员的信任度可能低于住院患者。我们在乌干达北部农村地区招募了 296 名参与者,其中 148 人(50%)来自社区,192 人(65%)为女性。与社区成员相比,住院病人对医学研究的平均信任度更高(p = 0.0001)。曾参与研究(p = 0.03)和愿意参与未来研究(p = 0.001)与信任度呈正相关。医务人员应更多地参与所在社区的工作,以促进对医学研究的信任。
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引用次数: 0
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Journal of Empirical Research on Human Research Ethics
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