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Journal of Empirical Research on Human Research Ethics最新文献

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Considerations for the Design of Informed Consent in Digital Health Research: Participant Perspectives. 数字健康研究中知情同意设计的考虑因素：参与者的观点。
IF 1.7 4区 哲学
Journal of Empirical Research on Human Research Ethics Pub Date : 2024-10-01 Epub Date: 2024-10-14 DOI: 10.1177/15562646241290078
Brian J McInnis, Ramona Pindus, Daniah Kareem, Camille Nebeker
{"title":"Considerations for the Design of Informed Consent in Digital Health Research: Participant Perspectives.","authors":"Brian J McInnis, Ramona Pindus, Daniah Kareem, Camille Nebeker","doi":"10.1177/15562646241290078","DOIUrl":"10.1177/15562646241290078","url":null,"abstract":"<p><p>The research team, prospective participants, and written materials all influence the success of the informed consent process. As digital health research becomes more prevalent, new challenges for successful informed consent are introduced. This exploratory research utilized a human centered design process in which 19 people were enrolled to participate in one of four online focus-groups. Participants discussed their experiences with informed consent, preferences for receiving study information and ideas about alternative consent approaches. Data were analyzed using qualitative methods. Six major themes and sixteen sub-themes were identified that included study information that prospective participants would like to receive, preferences for accessing information and a desire to connect with research team members. Specific to digital health, participants expressed a need to understand how the technologies worked and how the volume of granular personal information would be collected, stored, and shared.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"175-185"},"PeriodicalIF":1.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11588507/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142479534","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comparison of Instructions to Authors and Reporting of Ethics Components in Selected African Biomedical Journals: 2008 and 2017. 2008 年和 2017 年部分非洲生物医学期刊的作者须知和伦理内容报告比较。
IF 1.7 4区 哲学
Journal of Empirical Research on Human Research Ethics Pub Date : 2024-10-01 Epub Date: 2024-09-02 DOI: 10.1177/15562646241276237
Isaac O Dipeolu, Douglas R Wassenaar
{"title":"Comparison of Instructions to Authors and Reporting of Ethics Components in Selected African Biomedical Journals: 2008 and 2017.","authors":"Isaac O Dipeolu, Douglas R Wassenaar","doi":"10.1177/15562646241276237","DOIUrl":"10.1177/15562646241276237","url":null,"abstract":"<p><p>Journal editors instruct authors to describe human participant protections in original research reports. However, little is known about African biomedical journal authors' adherence to such journal editors' instructions. This study investigated changes in editors' instructions to authors and authors' reporting of research ethics information in selected African biomedical journals between 2008 and 2017. Twelve selected journal websites and online articles were reviewed in Eastern, Southern, and Western African [ESWA] countries. A pre-tested schema and a checklist were used to collect data from journal websites and articles published in 2008 and 2017, and the data were analysed using descriptive and inferential statistics. Half of the journals requested prospective authors to disclose ethics approval and related issues in their manuscripts between 2008 and 2017. There was a significant increase in instructions to authors regarding information on the protection of research participants within this period; more authors complied with these requirements in 2017 than in 2007.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"238-249"},"PeriodicalIF":1.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142114330","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
An Example of a Clinical Research Ethics Committee in Türkiye: Types of Studies Analysed, Their Phases and Investigators. 土耳其临床研究伦理委员会实例：分析的研究类型、阶段和研究者。
IF 1.7 4区 哲学
Journal of Empirical Research on Human Research Ethics Pub Date : 2024-10-01 Epub Date: 2024-08-09 DOI: 10.1177/15562646241273162
Gungor Buket
{"title":"An Example of a Clinical Research Ethics Committee in Türkiye: Types of Studies Analysed, Their Phases and Investigators.","authors":"Gungor Buket","doi":"10.1177/15562646241273162","DOIUrl":"10.1177/15562646241273162","url":null,"abstract":"<p><p>Clinical studies are reviewed by clinical research ethics committees (CRECs) in order to ensure that they are conducted within the framework of good clinical practice and that the rights of volunteers are respected. Research type, department, status, scope, principal investigator's characteristics and CREC decisions were all evaluated. A total of 1044 research applications were found to have been submitted. In addition, 14.6% of the applications were clinical trials and 48.8% were retrospective studies. Of all the researchers, 50.4% of them were found to have indicated an incorrect type of research. The very low number of interventional clinical trials suggests that researchers tended to be hesitant about conducting such trials or did not have the means to do so. The fact that the applications were often submitted by indicating a wrong type of research method also signifies the investigators' lack of knowledge in this regard.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"226-235"},"PeriodicalIF":1.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141908198","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
Public Perspectives on Consent for and Governance of Biobanking in Japan. 日本公众对生物银行同意和管理的看法。
IF 1.7 4区 哲学
Journal of Empirical Research on Human Research Ethics Pub Date : 2024-10-01 Epub Date: 2024-09-27 DOI: 10.1177/15562646241286143
Masanori Oikawa, Yoshiyuki Takimoto
{"title":"Public Perspectives on Consent for and Governance of Biobanking in Japan.","authors":"Masanori Oikawa, Yoshiyuki Takimoto","doi":"10.1177/15562646241286143","DOIUrl":"10.1177/15562646241286143","url":null,"abstract":"<p><p>Through strengthened biobank governance, broad consent has been widely accepted as a means to replace donors' discretion based on the information of individual research protocols. Trust and other ethical and social notions, such as reciprocity and solidarity, are key concepts that support biobank governance. The types of allowed broad consent are several; however, they remain unclear, and whether these ethical and social notions are associated with public attitudes toward the consent model is not fully understood. This quantitative study examined two hypotheses: narrower and limited broad consent are more accepted by the public, and acceptance rates for broad consent increase with established measures related to biobank governance. This analysis supported both hypotheses, implying that the limited type of broad consent should be considered an important option, and that a specific type of governance is critical in promoting trust, reciprocity, and solidarity between biobanks and the public.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"208-219"},"PeriodicalIF":1.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142331536","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
Decision-Making Capabilities of Artificial Intelligence Platforms as Institutional Review Board Members: Comment. 人工智能平台作为机构审查委员会成员的决策能力：评论。
IF 1.7 4区 哲学
Journal of Empirical Research on Human Research Ethics Pub Date : 2024-10-01 Epub Date: 2024-08-09 DOI: 10.1177/15562646241273804
Hinpetch Daungsupawong, Viroj Wiwanitkit
{"title":"Decision-Making Capabilities of Artificial Intelligence Platforms as Institutional Review Board Members: Comment.","authors":"Hinpetch Daungsupawong, Viroj Wiwanitkit","doi":"10.1177/15562646241273804","DOIUrl":"10.1177/15562646241273804","url":null,"abstract":"","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"236-237"},"PeriodicalIF":1.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141908199","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
Perceptions of the Research Integrity Climate in Egyptian Universities: A Survey Among Academic Researchers. 对埃及大学科研诚信氛围的看法：学术研究人员调查。
IF 1.7 4区 哲学
Journal of Empirical Research on Human Research Ethics Pub Date : 2024-10-01 Epub Date: 2024-08-09 DOI: 10.1177/15562646241273097
Elsayed Abdelkreem, Maha Emad Ibrahim, Sawsan Elateek, Fatma Abdelgawad, Henry J Silverman
{"title":"Perceptions of the Research Integrity Climate in Egyptian Universities: A Survey Among Academic Researchers.","authors":"Elsayed Abdelkreem, Maha Emad Ibrahim, Sawsan Elateek, Fatma Abdelgawad, Henry J Silverman","doi":"10.1177/15562646241273097","DOIUrl":"10.1177/15562646241273097","url":null,"abstract":"<p><p><b>Problem:</b> Investigations regarding perceptions of the institutional research integrity climate in the Arab Middle East remain underexplored. <b>Subjects:</b> We surveyed faculty from three Egyptian universities. <b>Method:</b> We utilized the Survey of Organizational Research Climate (SOuRCe) tool, which incorporates seven subscales that measure different aspects of the research integrity climate. Responses were obtained from a 5-point Likert scale. <b>Findings:</b> Of the 228 participants, the subscales 'Regulatory Quality' and '[Lack of] Integrity Inhibitors' received the highest mean scores, whereas the lowest scores pertained to 'Departmental Expectations,' 'Integrity Socialization,' and 'Responsible Conduct of Research´ indicating areas in need of improvement. <b>Conclusions:</b> Academic leaders should set fairer expectations for research and funding for their researchers, ensure junior researchers are socialized into research integrity practices, and promote effective RCR training and availability of RCR policies. We identify specific targeted interventions to enhance the research integrity climate within these institutions.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"250-262"},"PeriodicalIF":1.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11588560/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141908200","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Understanding of Key Considerations for Effective Community Engagement in Genetics and Genomics Research: A Qualitative Study of the Perspectives of Research Ethics Committee Members and National Research Regulators in a low Resource Setting. 了解遗传学和基因组学研究中社区有效参与的主要考虑因素：对低资源环境下研究伦理委员会成员和国家研究监管机构观点的定性研究。
IF 1.7 4区 哲学
Journal of Empirical Research on Human Research Ethics Pub Date : 2024-10-01 Epub Date: 2024-10-21 DOI: 10.1177/15562646241289015
Harriet Nankya, Vincent Pius Alibu, Edward Wamala, Enock Matovu, John Barugahare
{"title":"Understanding of Key Considerations for Effective Community Engagement in Genetics and Genomics Research: A Qualitative Study of the Perspectives of Research Ethics Committee Members and National Research Regulators in a low Resource Setting.","authors":"Harriet Nankya, Vincent Pius Alibu, Edward Wamala, Enock Matovu, John Barugahare","doi":"10.1177/15562646241289015","DOIUrl":"10.1177/15562646241289015","url":null,"abstract":"<p><p>To attain effective community engagement (CE) for genetics and genomics research (GGR) is a challenge. This study aimed to analyzed participants' perspectives on how to attain effective CE for GGR in Uganda. A cross-sectional qualitative study involving in-depth interviews with twenty research ethics committee members and three national research regulators was conducted. GGR is faced with; low genetic literacy among stakeholders, social implications, cultural attitudes towards GGR, and lack of specific guidelines for CE in GGR. Attaining effective CE in GGR should involve; development of guidelines for GGR streamlining CE; boosting stakeholders' Knowledge in GGR and CE; engagement beyond sensitization; and consensus decision-making. Overall, attaining effective CE in GGR requires addressing the key aspects unique to GGR.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"197-207"},"PeriodicalIF":1.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142479535","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
Ready, Set, Sort! A User-Guide to Card Sorts for Community-Engaged Empirical Bioethics. 准备，开始，分类！社区参与实证生物伦理学卡片分类用户指南》。
IF 1.7 4区 哲学
Journal of Empirical Research on Human Research Ethics Pub Date : 2024-10-01 Epub Date: 2024-11-11 DOI: 10.1177/15562646241281802
Karen M Meagher, Sara Watson, Lia Kaz, Shawneequa Callier, Anya E R Prince, R Jean Cadigan
{"title":"Ready, Set, Sort! A User-Guide to Card Sorts for Community-Engaged Empirical Bioethics.","authors":"Karen M Meagher, Sara Watson, Lia Kaz, Shawneequa Callier, Anya E R Prince, R Jean Cadigan","doi":"10.1177/15562646241281802","DOIUrl":"10.1177/15562646241281802","url":null,"abstract":"<p><p>We demonstrate the fruitfulness of using card sort activities as an engagement method by detailing community consultation for ethical, legal, and social implications of sociogenomics. Readers are provided with a user-guide for card sort engagement through: (1) an overview of the card sort activity and its merits for engagement, (2) detailed methods of sorting for values-elicitation and prioritization goals, and (3) strategies to design this approach for other participatory research designs. Our intent is to add to meaningful exchanges between community engaged researchers and empirical bioethicists.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"186-196"},"PeriodicalIF":1.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11630629/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142631904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Obtaining Consent for Research on Risky Behaviours Among Adolescents in Canada: A Scoping Review. 加拿大青少年危险行为研究同意书的获取：范围审查》。
IF 1.7 4区 哲学
Journal of Empirical Research on Human Research Ethics Pub Date : 2024-07-01 Epub Date: 2024-05-15 DOI: 10.1177/15562646241253953
Lillian MacNeill, A Luke MacNeill, Shelley Doucet, Alison Luke, Alex Goudreau
{"title":"Obtaining Consent for Research on Risky Behaviours Among Adolescents in Canada: A Scoping Review.","authors":"Lillian MacNeill, A Luke MacNeill, Shelley Doucet, Alison Luke, Alex Goudreau","doi":"10.1177/15562646241253953","DOIUrl":"10.1177/15562646241253953","url":null,"abstract":"<p><p>This scoping review explores current practices for obtaining consent in research on risky behaviours among adolescents in Canada. The JBI methodology for scoping reviews was used. The database search was conducted in August 2021 and updated in November 2022. Papers published in 2010 or later were included. Extracted data included study characteristics, sample characteristics, and consent procedures. The review included 83 reports covering 57 studies. Nearly 60% of studies relied on adolescent self-consent for participation. Adolescent self-consent was more common than parental/guardian consent for studies using in-person research methods, older adolescent groups, and particularly vulnerable populations. Parental/guardian consent was more common for studies using younger age groups and general population samples. Adolescent self-consent was more common than parental/guardian consent for most risky behaviours covered by this review. These results provide insight into current consent practices in this area and offer guidance to researchers and institutional review boards in Canada.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"124-134"},"PeriodicalIF":1.7,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11298111/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140946444","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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
Journal of Empirical Research on Human Research Ethics Pub Date : 2024-07-01 Epub Date: 2024-06-17 DOI: 10.1177/15562646241263200
Kannan Sridharan, Gowri Sivaramakrishnan
{"title":"Assessing the Decision-Making Capabilities of Artificial Intelligence Platforms as Institutional Review Board Members.","authors":"Kannan Sridharan, Gowri Sivaramakrishnan","doi":"10.1177/15562646241263200","DOIUrl":"10.1177/15562646241263200","url":null,"abstract":"<p><p><b>Background:</b> 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. <b>Methods:</b> 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. <b>Results:</b> 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. <b>Conclusion:</b> AI platforms could aid IRB decision-making and improve review efficiency. However, human oversight remains critical for ensuring the accuracy of AI-generated solutions.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"83-91"},"PeriodicalIF":1.7,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141421609","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
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