Journal of empirical research on human research ethics : JERHRE最新文献_第4页

Community Perspectives on Ethical Considerations in Clinical Research: Lessons from the ESRIFAL Clinical Trial in the Meme River Basin, Cameroon. 临床研究中伦理考虑的社区视角：来自喀麦隆梅梅河流域ESRIFAL临床试验的经验教训

IF 1.1

Journal of empirical research on human research ethics : JERHRE Pub Date : 2026-07-01 Epub Date: 2026-03-31 DOI: 10.1177/15562646261437182

Agbor Junior Agbor Ayuk, Emmanuel Yenshu Vubo

引用次数: 0

Survey of the Current status and Challenges of Centralized Review in Multicenter Research in Japan. 日本多中心研究集中审查的现状与挑战。

IF 1.1

Journal of empirical research on human research ethics : JERHRE Pub Date : 2026-07-01 Epub Date: 2026-04-13 DOI: 10.1177/15562646261441433

Mikihiro Shimizu, Takayuki Oguma, Keiichi Odagiri, Naoki Inui

{"title":"Survey of the Current status and Challenges of Centralized Review in Multicenter Research in Japan.","authors":"Mikihiro Shimizu, Takayuki Oguma, Keiichi Odagiri, Naoki Inui","doi":"10.1177/15562646261441433","DOIUrl":"10.1177/15562646261441433","url":null,"abstract":"Centralized review can streamline multicenter research by shortening timelines, harmonizing decisions, and reducing administrative burden. However, adoption in Japan remains limited because many committees operate independently and regulations are complex. We conducted a questionnaire survey of 27 institutions in the Shizuoka Clinical Trials Network. For centralized review, we assessed feasibility, prior requests, and implementation experience. Twenty-two institutions responded, covering a range of hospital sizes and ethics review volumes. Although only 6 (27.3%) had implemented centralized review, 13 (59.1%) had received requests or inquiries, indicating demand where implementation has not occurred. Commonly cited barriers were inability to prepare procedures, staff shortages, and concerns about review quality. The main needs for implementation were personnel supplementation, knowledge and experience sharing, and system development. Addressing these challenges through standardized processes and unified document formats, shared from high volume institutions and supported by government led infrastructure, may promote wider adoption and reduce administrative workload.","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"103-113"},"PeriodicalIF":1.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147679864","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Ethical Frameworks for Conducting Social Challenge Studies. 开展社会挑战研究的伦理框架。

IF 1.1

Journal of empirical research on human research ethics : JERHRE Pub Date : 2026-07-01 Epub Date: 2026-04-04 DOI: 10.1177/15562646261437269

Protiva Sen, Laurent Hébert-Dufresne, Pablo Bose, Juniper Lovato

{"title":"Ethical Frameworks for Conducting Social Challenge Studies.","authors":"Protiva Sen, Laurent Hébert-Dufresne, Pablo Bose, Juniper Lovato","doi":"10.1177/15562646261437269","DOIUrl":"10.1177/15562646261437269","url":null,"abstract":"Computational social science research, particularly online studies, often involves exposing participants to the adverse phenomenon the researchers aim to study. Examples include presenting conspiracy theories in surveys, exposing systems to hackers, or deploying bots on social media. We refer to these as \"social challenge studies,\" by analogy with medical research, where challenge studies advance vaccine and drug testing but also raise ethical concerns about exposing healthy individuals to risk. Medical challenge studies are guided by established ethical frameworks that regulate how participants are exposed to agents under controlled conditions. In contrast, social challenge studies typically occur with less control and fewer clearly defined ethical guidelines. In this paper, we examine the ethical frameworks developed for medical challenge studies and consider how their principles might inform social research. Our aim is to initiate discussion on formalizing ethical standards for social challenge studies and encourage long-term evaluation of potential harms.","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"161-184"},"PeriodicalIF":1.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13250264/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147619373","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The Challenges of Web Scraping and AI for Research Ethics in Canada: A Survey of University REBs. 网络抓取和人工智能对加拿大研究伦理的挑战：对大学reb的调查。

IF 1.1

Journal of empirical research on human research ethics : JERHRE Pub Date : 2026-07-01 Epub Date: 2026-03-23 DOI: 10.1177/15562646261434135

Alicia Cappello, Catherine Stinson

引用次数: 0

Governance Structures for Health Research Ethics in the Eastern Mediterranean Region. 东地中海区域卫生研究伦理的治理结构。

IF 1.1

Journal of empirical research on human research ethics : JERHRE Pub Date : 2026-07-01 Epub Date: 2026-04-01 DOI: 10.1177/15562646261437175

Ahmed Mandil, Arash Rashidian, Arshad Altaf, Andreas Reis

{"title":"Governance Structures for Health Research Ethics in the Eastern Mediterranean Region.","authors":"Ahmed Mandil, Arash Rashidian, Arshad Altaf, Andreas Reis","doi":"10.1177/15562646261437175","DOIUrl":"10.1177/15562646261437175","url":null,"abstract":"IntroductionThis work aimed at mapping research ethics governance at EMR countries.MethodsThe study used two tools shared with Eastern Mediterranean Region (EMR) countries. The first enquired about legal provisions and regulatory frameworks, as well as Research Ethics Committee (REC) composition, resources, procedures. The second covered ethical oversight of clinical trials (CTs), including coordination of ethical reviews.ResultsMost respondents (85%) indicated that they have national provisions requiring human subjects' research to be REC-reviewed. Around half (46%) reported having legal provisions requiring CTs to be registered on a registry; having a national or institution-specific CT registry (43%); and protecting participants from any financial consequences if they suffer injury as result of their participation (54%).RecommendationsEMR countries are encouraged to develop / foster / accredit national and institution-based RECs, as well as national CT registries. Members of REC committees should have knowledge and skills to ethically review research, in compliance with international standards.","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"92-102"},"PeriodicalIF":1.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147597491","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A 360 Degree Qualitative Ethical Assessment of Reporting Patient Reported Outcomes. 报告患者报告结果的360度定性伦理评估。

IF 1.1

Journal of empirical research on human research ethics : JERHRE Pub Date : 2026-07-01 Epub Date: 2026-04-30 DOI: 10.1177/15562646261441724

Andrew P Huang, Jennifer Corcoran, Christine Zizzi, Connor DeFehr, Angela Contento, Lainie Ross, Benzi Kluger

{"title":"A 360 Degree Qualitative Ethical Assessment of Reporting Patient Reported Outcomes.","authors":"Andrew P Huang, Jennifer Corcoran, Christine Zizzi, Connor DeFehr, Angela Contento, Lainie Ross, Benzi Kluger","doi":"10.1177/15562646261441724","DOIUrl":"10.1177/15562646261441724","url":null,"abstract":"While guidelines exist for returning genetic, biomarker, and radiologic research results, there is little guidance regarding the return of patient-reported outcome (PRO) research results. As a supplement to an ongoing trial of palliative care for Parkinson's disease, we conducted thirty qualitative, semi-structured interviews of persons with Parkinson's disease, their carepartners, community neurologists, primary care physicians, and researchers to elicit their perceptions of returning PRO research data to persons with Parkinson's disease and carepartners. Interviews were audio-taped, transcribed, double-coded, and analyzed for themes. Participants supported returning tailored PRO research results when feasible. Clinicians wanted clinically-actionable results. Researchers thought that returning aggregate results should be standard practice. However, our persons with Parkinson's disease and carepartners reported privacy concerns. Clinicians had mixed reactions about receiving non-actionable research results. Researchers worried whether returning individual results during a study could impact research integrity. Additional research is needed to develop optimal guidelines for future research studies.","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"220-232"},"PeriodicalIF":1.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13160637/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147826132","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Optimizing Pathways for Common Issues in Administrative Review of Submission Materials of Investigator-Initiated Clinical Trials: Evidence from a Leading Chinese Hospital. 优化研究者发起的临床试验提交材料行政审查中常见问题的途径：来自中国一家领先医院的证据。

IF 1.1

Journal of empirical research on human research ethics : JERHRE Pub Date : 2026-07-01 Epub Date: 2026-02-04 DOI: 10.1177/15562646261418342

Lu Liu, Wenjiao Jiao, Jiasheng Zhang, Lili Cao

{"title":"Optimizing Pathways for Common Issues in Administrative Review of Submission Materials of Investigator-Initiated Clinical Trials: Evidence from a Leading Chinese Hospital.","authors":"Lu Liu, Wenjiao Jiao, Jiasheng Zhang, Lili Cao","doi":"10.1177/15562646261418342","DOIUrl":"10.1177/15562646261418342","url":null,"abstract":"This study evaluates the quality and efficiency of administrative review for investigator-initiated trials (IITs) at a leading tertiary hospital in Shandong Province, China. We conducted a retrospective empirical comparative analysis using feedback reports issued by the Clinical Research Management Office. A total of 151 reports from 2022 were compared with 162 reports from September 2023 to August 2024, after targeted improvement measures were introduced. Interventions focused on management enhancement, standardized submission templates, and systematic training. Results showed that incomplete study materials, insufficient informed consent information, inadequate researcher qualifications, and non-compliant signatures all decreased significantly (p < 0.05). The average number of issues per project declined from 3.76 to 3.10, and the proportion of high-quality submissions increased from 17.2% to 34.0% (p < 0.05). These results demonstrate that structured management and capacity-building measures can improve submission quality and review efficiency, offering practical pathways for optimizing oversight of IITs in medical institutions.","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"82-91"},"PeriodicalIF":1.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146121714","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Decision Letters from a Kyrgyz Research Ethics Committee (2018-2022): An Empirical Review of Transparency, Rigor, and Communication. 从吉尔吉斯研究伦理委员会（2018-2022）的决定书：透明度，严谨性和沟通的实证审查。

IF 1.1

Journal of empirical research on human research ethics : JERHRE Pub Date : 2026-07-01 Epub Date: 2026-03-03 DOI: 10.1177/15562646261428333

Tamara Kudaibergenova, Nityanand Jain

{"title":"Decision Letters from a Kyrgyz Research Ethics Committee (2018-2022): An Empirical Review of Transparency, Rigor, and Communication.","authors":"Tamara Kudaibergenova, Nityanand Jain","doi":"10.1177/15562646261428333","DOIUrl":"10.1177/15562646261428333","url":null,"abstract":"Research Ethics Committees (RECs) safeguard participants, yet little is known about how their decisions are communicated to study investigators in low- and middle-income countries (LMICs). We analysed 138 decision letters from a public-health REC in Kyrgyzstan (2018-2022) using descriptive statistics and documentary review. REC panel consisted predominantly of clinical and biomedical experts, with identifying data missing for 51% (n = 506/991) of panelists. Lay member participation was absent despite being mandated in SOPs. The first-review approval rate was 55.1%. Communication in decision letters tended to be prescriptive rather than advisory, with critical ethical deficiencies often not flagged. Furthermore, there was a lack of explicit citation of national or international guidance. Our observations point to opportunities to improve transparency, review quality, and stakeholder engagement through standardized templates, targeted reviewer training, and the inclusion of lay members. Strengthening these practices may enhance consistency, quality, and trust in REC decision-making in comparable post-Soviet LMICs contexts.","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"114-128"},"PeriodicalIF":1.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13250262/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147346145","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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Bridging the Gap: Effective Strategies for Recruiting and Retaining Diverse Participants in Clinical Trials. 弥合差距：在临床试验中招募和保留不同参与者的有效策略。

IF 1.1

Journal of empirical research on human research ethics : JERHRE Pub Date : 2026-07-01 Epub Date: 2026-05-21 DOI: 10.1177/15562646261444217

Taneal D Carter, Kevin Rogers

{"title":"Bridging the Gap: Effective Strategies for Recruiting and Retaining Diverse Participants in Clinical Trials.","authors":"Taneal D Carter, Kevin Rogers","doi":"10.1177/15562646261444217","DOIUrl":"10.1177/15562646261444217","url":null,"abstract":"BackgroundClinical trials are vital for advancing medical knowledge, yet engaging diverse populations-those under-represented due to race, age, income, education, geography, sexual orientation, or gender identity-remains a challenge, limiting research generalizability.MethodsThis study used a literature review and semi-structured interviews with participants from diverse backgrounds recruited on LinkedIn. A demographic survey was conducted via Qualtrics, yielding 21 responses and 15 study participants. The research identified barriers to participation: inadequate community engagement, trial awareness, mistrust, and unaddressed social determinants of health, with data analyzed for key themes.ResultsFour themes emerged: (1) Community engagement builds trust; (2) Addressing social determinants alleviates barriers; (3) Peer education empowers participants; (4) A representative workforce enhances recruitment.DiscussionFindings emphasize the necessity of inclusive practices in clinical research, highlighting that targeted strategies can improve diversity in clinical trials, leading to more equitable healthcare outcomes. Future research should refine these strategies in specific therapeutic areas.","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"233-243"},"PeriodicalIF":1.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147985023","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Implications of COVID-19 Restrictions on the Ethics and Methods of a Multi-Site Study on Alcohol and Other Drug (AOD) Use Treatment among Men in South Africa. COVID-19限制对南非男性酒精和其他药物（AOD）使用治疗的多地点研究的伦理和方法的影响

IF 1.1

Journal of empirical research on human research ethics : JERHRE Pub Date : 2026-07-01 Epub Date: 2026-03-19 DOI: 10.1177/15562646261427563

Neo K Morojele, Leslie London, Amina Saban, Bronwyn Myers, Nadine Harker, Kebogile Mokwena, Zukiswa Zingela, Sebenzile Nkosi, Philip Ayieko, Saidi Kapiga

{"title":"Implications of COVID-19 Restrictions on the Ethics and Methods of a Multi-Site Study on Alcohol and Other Drug (AOD) Use Treatment among Men in South Africa.","authors":"Neo K Morojele, Leslie London, Amina Saban, Bronwyn Myers, Nadine Harker, Kebogile Mokwena, Zukiswa Zingela, Sebenzile Nkosi, Philip Ayieko, Saidi Kapiga","doi":"10.1177/15562646261427563","DOIUrl":"10.1177/15562646261427563","url":null,"abstract":"Public health measures for medical emergencies generate methodological and ethical challenges for human research. Using Emanuel et al.'s framework, we assessed the ethical integrity of the research methods used in a men's alcohol and other drug (AOD) use disorder study following their revision due to COVID-19 restrictions in South Africa. Following the amendments, the study's social value, favorable risk-benefit ratio, and respect for participants increased. Collaborative partnership, scientific validity, fair participant selection, independent review, and informed consent improved in terms of successful stakeholder engagements and interviewing procedures, but were compromised due to a cellphone access eligibility criterion and complicated consenting procedures. Methodological and ethical challenges of research during health emergencies can be navigated with flexibility and innovation.","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"134-147"},"PeriodicalIF":1.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13250275/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147489288","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0