Timothy Daly, Ignacio Mastroleo, Luis L García Valiña, Irene Melamed, María Florencia Santi, Theresa J Ochoa, Manuela Fernández Pinto, Paul J Cummins, Bernardo García Camino, Cheryl Macpherson, Elizabeth Heitman, Florencia Luna
{"title":"Fogarty-Funded Research Ethics Education in Latin America and the Caribbean: Progress Despite Ongoing Challenges.","authors":"Timothy Daly, Ignacio Mastroleo, Luis L García Valiña, Irene Melamed, María Florencia Santi, Theresa J Ochoa, Manuela Fernández Pinto, Paul J Cummins, Bernardo García Camino, Cheryl Macpherson, Elizabeth Heitman, Florencia Luna","doi":"10.1177/15562646251325621","DOIUrl":"https://doi.org/10.1177/15562646251325621","url":null,"abstract":"<p><p>Ten years have passed since the last regional assessment of the state of Fogarty International Center-funded research ethics education and challenges facing research ethics in Latin America and the Caribbean basin. Program directors and faculty from four international research ethics education programs met in Spring 2024 to discuss their progress, challenges, and future priorities. The themes that emerged from these discussions were the structural difficulties faced by regional ethicists, the use of pedagogical innovations to mitigate different barriers faced by fellows, and the need to anticipate future challenges for the region including climate change.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"15562646251325621"},"PeriodicalIF":1.7,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143755131","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}
Nishakanthi Gopalan, Robyna Irshad Khan, Henry J Silverman, Jeremy Sugarman, Vina Vaswani
{"title":"Enhancing Research Ethics Capacity in Asia: Fogarty International Center Supported Initiatives in India, Malaysia, Myanmar, and Pakistan.","authors":"Nishakanthi Gopalan, Robyna Irshad Khan, Henry J Silverman, Jeremy Sugarman, Vina Vaswani","doi":"10.1177/15562646251323133","DOIUrl":"https://doi.org/10.1177/15562646251323133","url":null,"abstract":"<p><p>Several Asian countries, including India, Malaysia, Myanmar, and Pakistan, face challenges aligning rapid healthcare and biomedical research growth with necessary ethics oversight. To help address this, the Fogarty International Center of the United States National Institutes of Health funded initiatives to enhance research ethics capacities in these countries. In India, the Yenepoya University's Master's in Research Ethics program was established in collaboration with Monash University. In Malaysia, the Master of Health Research Ethics (MOHRE) program, based at Universiti Malaya, was developed in collaboration with the Johns Hopkins University. In Myanmar, a Diploma in Research Methodology and Research Ethics (DipRMRE) was introduced in cooperation with the University of Maryland Baltimore. In Pakistan, a Master of Bioethics (MBE) program was designed to address the country's unique ethical challenges in healthcare and research. Graduates from these programs have significantly contributed to health research and policy, enhancing research ethics infrastructure across these diverse Asian countries.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"15562646251323133"},"PeriodicalIF":1.7,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143651688","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}
{"title":"Validating the Attitudes Toward Plagiarism Scale and Examining the Interrelationships among its Constructs.","authors":"Md Atikuzzaman, S M Zabed Ahmed","doi":"10.1177/15562646251327541","DOIUrl":"https://doi.org/10.1177/15562646251327541","url":null,"abstract":"<p><p>This study validates the Attitudes Toward Plagiarism (ATP) scale and investigates the interrelationships among its three constructs: positive attitudes, negative attitudes, and subjective norms regarding plagiarism. Data were collected from 720 students across two universities in Bangladesh. Exploratory factor analysis (EFA) was conducted on data from one university (<i>n </i>= 412), followed by confirmatory factor analysis (CFA) on data from another university (<i>n </i>= 308). The EFA extracted 20 items from the original 29-item ATP scale, while the CFA retained a 17-item version. Both analyses confirmed the ATP's original three-factor structure. Pearson's correlation and structural equation modeling (SEM) were performed using the total sample (<i>n </i>= 720) to examine the relationships among the constructs. The results of Pearson's correlation showed significant positive correlations among the ATP constructs. SEM analysis revealed that subjective norms significantly influenced positive attitudes, and positive attitudes significantly mediated the relationship between subjective norms and negative attitudes toward plagiarism.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"15562646251327541"},"PeriodicalIF":1.7,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143651692","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}
{"title":"Improving Comprehension of Consent Forms in Online Research: An Empirical Test of Four Interventions.","authors":"Naomi K Grant, Leah K Hamilton, Jenalyn M Ormita","doi":"10.1177/15562646251321132","DOIUrl":"https://doi.org/10.1177/15562646251321132","url":null,"abstract":"<p><p>Informed consent is a guiding ethical principle when conducting research involving human participants. Yet, consent forms are often skimmed or ignored, jeopardizing informed consent. In two experiments, we test four interventions designed to encourage participants to read online consent forms more carefully. Experiment 1 employed a 2 (length: short or long) by 2 (timing: fixed or free) by 2 (quiz: present or absent) between-participants design. We measured instruction-following and comprehension of the consent form. Results showed that fixed timing and a quiz led to greater instruction-following, but consent form length had no effect. Experiment 2 employed a 2 (length: short or long) by 3 (delivery format: live, audiovisual, standard written) between-participants design. Once again, length had no effect, but both live and audiovisual formats increased instruction-following and comprehension. We recommend that researchers consider using fixed timing, adding a quiz, and/or using alternative delivery formats to help participants make an informed decision.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"15562646251321132"},"PeriodicalIF":1.7,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143626714","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}
Latifa Adarmouch, Alya Elgamri, Nivine Abbas, Hany Sleem, Henry Silverman
{"title":"Description and Impact of the 20-Year Fogarty International Center/NIH Middle East Research Ethics Training Initiative.","authors":"Latifa Adarmouch, Alya Elgamri, Nivine Abbas, Hany Sleem, Henry Silverman","doi":"10.1177/15562646251316711","DOIUrl":"https://doi.org/10.1177/15562646251316711","url":null,"abstract":"<p><p>The Middle East Research Ethics Training Initiative (MERETI), established in 2004 with funding from the Fogarty International Center at the NIH, aimed to enhance research ethics capacity in the Middle East North Africa (MENA) region. Initially focused on Egypt, MERETI expanded to other Arab countries, providing advanced training in international research ethics to over 100 individuals. The program emphasized additional skills in research methodology, pedagogy, scientific writing, and leadership. MERETI's training evolved from a one-year program to a two-year model incorporating sequential hybrid/blended and asynchronous online components and, eventually, included a fully online 12-credit graduate certificate in research ethics. The program's impact is demonstrated through the professional achievements of its trainees, which included publishing in peer-reviewed journals, assuming key roles in national research ethics committees and ministries of health and contributing to the development of ethics research practices in their respective countries. MERETI also fostered a sustainable Egyptian network of research ethics committees.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"15562646251316711"},"PeriodicalIF":1.7,"publicationDate":"2025-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143537899","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}
Valerie J Flaherman, Victoria Nankabirwa, Amy Sarah Ginsburg
{"title":"Searching for Evidence-Based Interventions When Infant Malnutrition Persists in the Setting of Support for Exclusive Breastfeeding.","authors":"Valerie J Flaherman, Victoria Nankabirwa, Amy Sarah Ginsburg","doi":"10.1177/15562646241301823","DOIUrl":"https://doi.org/10.1177/15562646241301823","url":null,"abstract":"","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"15562646241301823"},"PeriodicalIF":1.7,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143366708","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}
Erik Rein-Hedin, Mårten Schultzberg, Folke Sjöberg, Fredrik Huss
{"title":"Characteristics, Motivations, and Preferences of Healthy Volunteers in Phase I Clinical Trials in Sweden.","authors":"Erik Rein-Hedin, Mårten Schultzberg, Folke Sjöberg, Fredrik Huss","doi":"10.1177/15562646241309142","DOIUrl":"https://doi.org/10.1177/15562646241309142","url":null,"abstract":"<p><p>This study examined the characteristics, experiences, motivations, and preferences of healthy volunteers participating in Phase I clinical trials in Sweden. A descriptive, cross-sectional survey was conducted among 135 healthy volunteers who had participated in at least one Phase I clinical trial from 2021 to 2024. Volunteers considered trial personnel, financial compensation, and regulatory review and approval as highly important factors in their decision to participate. Willingness to participate varied depending on trial characteristics, with greater reluctance for trials involving discomfort or perceived higher risks. Experiences, motivations, and preferences were comparable irrespective of age, gender, occupation, or income. Participants had disproportionately low incomes but reported financial satisfaction comparable to the general population. Unlike findings in other regions, there was no overrepresentation of migrants or the unemployed. Insights from this study can help guide trial design considerations to facilitate equitable recruitment and reduce the burden of participation.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"15562646241309142"},"PeriodicalIF":1.7,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143048453","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}
{"title":"Putting an Ethics Training Program Online: It May Be More Complicated Than We Think.","authors":"Cheryl K Stenmark","doi":"10.1177/15562646251313577","DOIUrl":"https://doi.org/10.1177/15562646251313577","url":null,"abstract":"<p><p>This project evaluated the online implementation of a Responsible Conduct of Research/Professional Ethics Training for graduate students. The program was offered as a video-streamed remote, real-time training with an in-person option. Effectiveness of the remote program was evaluated using multiple measures: perceptions of ethical dilemmas, ethical decision-making, and reactions to the training. Pre-post training comparisons indicated participants' scores were lower after training on some outcomes. Results comparing training modalities suggest post-training reductions in scores were largely driven by remote participants. In-person participants performed significantly better on several measures compared to remote participants. All participants had favorable reactions to the program. Results suggest that putting an ethics training online may require an innovative approach to program development, better planning and preparation by the training institution, and more research, to determine the most effective way to proceed.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":" ","pages":"15562646251313577"},"PeriodicalIF":1.7,"publicationDate":"2025-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143015386","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}
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":"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}
{"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}