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Identifying Strategies for Strengthening Behavioral and Social Science Research Study Conduct.
IF 1.7 4区 哲学
Journal of Empirical Research on Human Research Ethics Pub Date : 2024-12-18 DOI: 10.1177/15562646241302396
Susan L Murphy, Timothy C Guetterman, Elizabeth K Haro, Sana Shakour
{"title":"Identifying Strategies for Strengthening Behavioral and Social Science Research Study Conduct.","authors":"Susan L Murphy, Timothy C Guetterman, Elizabeth K Haro, Sana Shakour","doi":"10.1177/15562646241302396","DOIUrl":"https://doi.org/10.1177/15562646241302396","url":null,"abstract":"<p><p>Behavioral and social science research (BSSR) studies are less stringently regulated compared to drug and device studies. At our university, internal quality assurance activities revealed BSSR studies have more, but similar, issues compared to other studies. However, most institutional resources are tailored to support drug and device research, leaving an evidence gap regarding effective strategies for fostering rigorous BSSR study conduct. Two campus units partnered to undertake a two-phase study. First, we characterized compliance issues based on BSSR study audit data. Second, we conducted interviews with behavioral researchers and others to discuss contributors to compliance issues and potential mitigating strategies. Through thematic analysis, we identified problems at that can be addressed at individual, study team, and university systems levels. Study results outline potential strategies to reduce compliance issues.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"15562646241302396"},"PeriodicalIF":1.7,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142848153","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
Medical Students' Views on Their Experience of Applying to Research Ethics Committees: A Qualitative Study.
IF 1.7 4区 哲学
Journal of Empirical Research on Human Research Ethics Pub Date : 2024-12-05 DOI: 10.1177/15562646241301824
Abdullah Yıldız, Ayşe Kurtoğlu, Berna Arda
{"title":"Medical Students' Views on Their Experience of Applying to Research Ethics Committees: A Qualitative Study.","authors":"Abdullah Yıldız, Ayşe Kurtoğlu, Berna Arda","doi":"10.1177/15562646241301824","DOIUrl":"https://doi.org/10.1177/15562646241301824","url":null,"abstract":"<p><p>The scope of medical training has expanded to encompass clinical skills and the ability to conduct and interpret scientific research. Therefore, medical students must develop an awareness of research and publication ethics to advance in their careers. This study aimed to understand medical students' perceptions of their first encounter with a research ethics committee. Qualitative methods were used to conduct three focus group interviews with students, and the data were thematically analysed. Findings revealed that the students had limited knowledge prior to their encounters, initially found the experience instructive yet challenging and negative, and later recognised its value. Students suggested enhancements to the practical and functional aspects of ethics committees and emphasised the need for ethics counselling in research.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"15562646241301824"},"PeriodicalIF":1.7,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142781532","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
Joint Editorial: Informed Consent and AI Transcription of Qualitative Data. 联合社论：定性数据的知情同意和人工智能转录。
IF 1.7 4区 哲学
Journal of Empirical Research on Human Research Ethics Pub Date : 2024-11-26 DOI: 10.1177/15562646241296712
Gabrielle Samuel, Doug Wassenaar
{"title":"Joint Editorial: Informed Consent and AI Transcription of Qualitative Data.","authors":"Gabrielle Samuel, Doug Wassenaar","doi":"10.1177/15562646241296712","DOIUrl":"https://doi.org/10.1177/15562646241296712","url":null,"abstract":"","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"15562646241296712"},"PeriodicalIF":1.7,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142734390","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
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
Vulnerable Research Participant Policies at U.S. Academic Institutions. 美国学术机构的弱势研究参与者政策。
IF 1.7 4区 哲学
Journal of Empirical Research on Human Research Ethics Pub Date : 2024-10-01 Epub Date: 2024-10-17 DOI: 10.1177/15562646241290093
Irene Jonathan, Eliza Akers, Min Shi, David B Resnik
{"title":"Vulnerable Research Participant Policies at U.S. Academic Institutions.","authors":"Irene Jonathan, Eliza Akers, Min Shi, David B Resnik","doi":"10.1177/15562646241290093","DOIUrl":"10.1177/15562646241290093","url":null,"abstract":"<p><p><b>Background:</b> Historically, some of the worst abuses of human research participants have involved populations which are vulnerable to coercion, harm, or exploitation, such as prisoners, children, and people with compromised decision-making abilities. Although there has been considerable philosophical and ethical debate about how to protect vulnerable populations, there have been only a handful of empirical studies on vulnerable population policies. <b>Methods:</b> We conducted a cross-sectional study on vulnerable population policies from the 105 top funded U.S. academic research institutions. We used deductive and inductive methods to develop our framework for coding the policies. We tested for associations between policies and research and development expenditure rank, public vs. private status, geographic region, and Association for Accreditation of Human Research Protection Programs accreditation (AAHRRP). <b>Results:</b> U.S. academic institutions have a variety of policies for research with vulnerable populations. Every institution in our sample had at least 2 policies for research with vulnerable populations (including a general policy) and most had 8 or more. As expected, the most highly prevalent policies pertained to populations covered in subparts B, C, and D of the Common Rule (pregnant women, fetuses, neonates, prisoners, and children) but other groups were well-represented, including people with disabilities; people with impaired decision-making capacity; students/trainees; and people with limited English proficiency including illiteracy. AAHRRP accreditation was positively associated with eight different types of policies. <b>Conclusion:</b> U.S. academic institutions have a variety of policies for research with vulnerable populations. Additional research is needed to better understand the types of safeguards that institutions have adopted to protect vulnerable populations and the factors that influence policy development.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"220-225"},"PeriodicalIF":1.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11588538/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142479536","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
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