Connie M Ulrich, Joseph Ali, Emily E Anderson, Carel IJsselmuiden, Nancy Kass, Kerim Munir, Mariana Kruger, Nhlanhla Mkhize, Keymanthri Moodley, Stuart Rennie, Nelson K Sewankambo, Bruno Sunguya, David Urassa, Douglas Wassenaar
{"title":"Advancing Doctoral and Postdoctoral International Bioethics Training Programs Supported by the D43 National Institutes of Health (NIH) Fogarty Mechanism.","authors":"Connie M Ulrich, Joseph Ali, Emily E Anderson, Carel IJsselmuiden, Nancy Kass, Kerim Munir, Mariana Kruger, Nhlanhla Mkhize, Keymanthri Moodley, Stuart Rennie, Nelson K Sewankambo, Bruno Sunguya, David Urassa, Douglas Wassenaar","doi":"10.1177/15562646251342882","DOIUrl":"https://doi.org/10.1177/15562646251342882","url":null,"abstract":"<p><p>Advancing doctoral and postdoctoral international bioethics training in low-and-middle income countries (LMICs) is essential to address the emerging and reemerging healthcare needs of local populations. The COVID-19 pandemic underscored the need for sustenance of global collaboration and rapid adaptability in the future to further prioritize research frameworks to benefit LMICs. Thus, the purpose of the manuscript is to share the successes, challenges, and future considerations of building bioethics research capacity in seven federally funded training programs supported by the Fogarty International Center of the National Institutes of Health D43 mechanism. We advocate for continued investment in training programs recognizing that it requires committed time and effort, specialized funding opportunities, cultural sensitivity, and interdisciplinary faculty support both domestically and internationally. This investment supports cross-disciplinary collaboration, enhances the ethical conduct of research and recognizes the importance of context-sensitive research that generates evidence-based data for global solutions.</p>","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"15562646251342882"},"PeriodicalIF":0.0,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144500291","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}
{"title":"A Critical Assessment of the Quality of Reporting of Ethical Protections in Medical Papers Published in Turkey.","authors":"M Kemal Temel","doi":"10.1177/15562646221108600","DOIUrl":"https://doi.org/10.1177/15562646221108600","url":null,"abstract":"<p><p>The Declaration of Helsinki (DoH), the International Committee of Medical Journal Editors (ICMJE) recommendations, and the Committee on Publication Ethics (COPE) guidelines outline the basic principles for ethical conduct and publication of human-subject research, most notably informed consent (IC) and research ethics committee (REC) approval. This retrospective observational study was a first study to investigate the quality of reporting of these protections in a selected sample of medical papers published in Turkey. A total of 573 research articles published in the official journals of six leading Turkish medical schools between January 2018 and December 2020 were searched for information on obtaining (i) REC approval, (ii) written IC from research subjects or their legal guardians/representatives, and (iii) an REC-granted IC waiver when it was found, as stated in the DoH, \"impossible or impracticable to obtain consent\" from research subjects. Similarly, a total of 166 case reports were searched for a statement about publication-specific IC, as was recommended by COPE. Despite a statistically significant improvement over the years, the overall rates were found to be unsatisfactory. The protections were particularly misused or underused in retrospective research, where the rates of reporting written IC (15.41% vs. 48.61%) and REC approval with date and reference number information (45.38% vs. 61.11%) were significantly lower than in prospective research (<i>p</i> < .05). Both the practices of seeking and granting an IC waiver when no IC was obtained were extremely rare (n = 3). It was also found that the requirement of structured ethical information in research papers was associated with higher levels of ethics compliance, and that medical publishing in Turkey needed specific improvements, including better implementation of the protections already adopted in principle, clearer instructions for authors, more rigorous editorial scrutiny, and greater commitment to rejecting substandard submissions.</p>","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"504-514"},"PeriodicalIF":1.3,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40192336","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}
{"title":"The Profile of Articles on <i>AXIN2</i> Mutations, Oligodontia, and Ethical Statements in Dental Research.","authors":"R Constance Wiener","doi":"10.1177/15562646221116801","DOIUrl":"https://doi.org/10.1177/15562646221116801","url":null,"abstract":"<p><strong>Purpose: </strong>Editors often require ethical statements in research publications. This is particularly important with genetic data where discrimination may occur upon data disclosures. The purpose of this research is to determine if there was a positive trend of publishing ethical statements in dental genetic research. The study is limited to AXIN2 mutations which may be associated with oligodontia and cancer.</p><p><strong>Methods: </strong>A MEDLINE search of 2011-2021 articles concerning AXIN2, oligodontia, and ethical statements was conducted. Reviews, nonhuman subject research, abstracts, and articles not written nor translated into English were excluded.</p><p><strong>Results: </strong>Forty-four studies were found; 10 excluded. There were 25 (75.8%) with ethical statements, and 25 (75.8%) with participant consent statements. There was no significant difference by year in ethical statements over the ten years (p = 0.094).</p><p><strong>Conclusion: </strong>There is a need to encourage more ethical statements in publications especially for genetically sensitive topics to reassure readers of ethical practices.</p>","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"412-425"},"PeriodicalIF":1.3,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9502021/pdf/nihms-1823929.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40623441","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}
{"title":"Ethical Considerations for Discrete Choice Experiments with Caregivers.","authors":"Judy Illes, Ashley Lawson, Patrick J McDonald","doi":"10.1177/15562646221112339","DOIUrl":"https://doi.org/10.1177/15562646221112339","url":null,"abstract":"<p><p>We discuss research ethics challenges experienced while running a discrete choice experiment administered to caregivers of children with treatment resistant pediatric epilepsy. We highlight ethical considerations around the study design of the discrete choice experimental paradigm that pertain to vulnerability of and caregiving burden on the population, imbalance of benefit-to-load of participation, and limitations of cultural meaningfulness and generalizability.</p>","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"426-430"},"PeriodicalIF":1.3,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9398987/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40516437","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}
Frank G Preston, Yanda Meng, Yalin Zheng, James Hsuan, Kevin J Hamill, Austin G McCormick
{"title":"Informed Consent In Facial Photograph Publishing: A Cross-sectional Pilot Study To Determine The Effectiveness Of Deidentification Methods.","authors":"Frank G Preston, Yanda Meng, Yalin Zheng, James Hsuan, Kevin J Hamill, Austin G McCormick","doi":"10.1177/15562646221075459","DOIUrl":"https://doi.org/10.1177/15562646221075459","url":null,"abstract":"<p><p>This study determined the effectiveness of three deidentification methods: use of a) a black box to obscure facial landmarks, b) a letterbox view to display restricted facial landmarks and c) a half letterbox view. Facial images of well-known celebrities were used to create a series of decreasingly deidentified images and displayed to participants in a structured interview session. 55.5% were recognised when all facial features were covered using a black box, leaving only the hair and neck exposed. The letterbox view proved more effective, reaching over 50% recognition only once the periorbital region, eyebrows, and forehead were visible. The half letterbox was the most effective, requiring the nose to be revealed before recognition reached over 50%, and should be the option of choice where appropriate. These findings provide valuable information for informed consent discussions, and we recommend consent to publish forms should stipulate the deidentification method that will be used.</p>","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"373-381"},"PeriodicalIF":1.3,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9136482/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39850724","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}
{"title":"Knowledge and Attitudes of Research Participants in China Toward Electronic Informed Consent in Clinical Trials: A Cross Sectional Study.","authors":"Zhanqing Hu, Chenxi Ouyang, Jessica Hahne, Kaveh Khoshnood, Jinqiang Zhang, Xiyu Liu, Ying Wu, Xiaomin Wang","doi":"10.1177/15562646221075884","DOIUrl":"https://doi.org/10.1177/15562646221075884","url":null,"abstract":"<p><p>This study aims to investigate the knowledge and attitudes of participants and potential participants in clinical trials toward electronic informed consent. We conducted a survey-based cross-sectional study in Hunan Province, China in March 2021. A total of 547 respondents were included in this study. All questions in an 8-item survey section assessing participants' knowledge of electronic informed consent received correct answers from at least 70% of participants. In terms of attitude scores, most participants (86.3%) believed that electronic informed consent is more convenient than the paper-based version, and more than half (51.2%) believed that electronic informed consent could completely replace the paper-based version. Responses indicated that common concerns about electronic informed consent were its security and confidentiality, legal benefits, and implications for rights protection.</p>","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"362-372"},"PeriodicalIF":1.3,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9149068/pdf/nihms-1770674.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39866577","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}
{"title":"A Course for Teaching and Learning About the Responsible Conduct of Research.","authors":"M W Kalichman, M L Devereaux, D K Plemmons","doi":"10.1177/15562646211047163","DOIUrl":"https://doi.org/10.1177/15562646211047163","url":null,"abstract":"<p><p>Over the past 30 years, the scientific community has been increasingly challenged to provide the next generation of researchers with training in responsible conduct of research (RCR). Although RCR courses, workshops, and seminars are now routinely taught internationally, there is little uniformity in goals, content, pedagogy, duration, class size, or methods of assessment. The result is a mixed picture of effectiveness. In this manuscript, we describe goals, rationales, and features for a course tested and revised through well over 100 iterations. Based on our experience and that of others with whom we have shared this model, we propose this course as one that RCR instructors might readily and successfully adopt or adapt.</p>","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"284-291"},"PeriodicalIF":1.3,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9008073/pdf/nihms-1737652.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39519167","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}
{"title":"AER Conference poster abstracts in JERHRE.","authors":"","doi":"10.1177/15562646211072503","DOIUrl":"https://doi.org/10.1177/15562646211072503","url":null,"abstract":"Research education for a large health network is a challeng-ing business. Our audience is diverse, large, and includes a myriad of researchers, staff, and administrators with varying levels of experience. We offer a host of educational opportunities and were interested in the researchers ’ perspectives on their educational needs and wants. Background In response to the COVID-19 pandemic and suspension of in-person research, Teachers College Institutional Review Board (TC IRB) sought to determine how research submissions were impacted over the course of the 2020-2021 aca-demic year. We developed a self-study to gauge the needs and concerns of researchers preparing for ramp-up efforts. Over the past year, investigators at our psychiatric research institution shifted focus to investigate the effects of the pandemic related to mental illness. We examined how many (1) new studies and (2) modi fi cations of existing studies were submitted to assess the effects of the pandemic on individuals with psychiatric disorders.","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"401-408"},"PeriodicalIF":1.3,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39851335","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}
{"title":"Seeking Approval from Universities to Research the Views of Their Staff. Do Gatekeepers Provide a Barrier to Ethical Research?","authors":"Katherine Christian, Carolyn Johnstone, Jo-Ann Larkins, Wendy Wright","doi":"10.1177/15562646211068316","DOIUrl":"https://doi.org/10.1177/15562646211068316","url":null,"abstract":"<p><p>A \"gatekeeper\" controls access to an organization; \"gatekeeper approval\" is often needed before external research can take place within an organization. We explore the need for gatekeeper approval for research with university staff employing, as a case study, a project which collected data in Australia. This case study addresses known issues, seemingly rarely addressed in the literature. The Human Research Ethics Committee (HREC)'s requirement for approval from individual universities to approach their staff brought significant consequences, exacerbated by the lack of university procedures for such approvals. Simultaneously, since invitations could legitimately be distributed via other avenues, such approval was superfluous. We recommend the HREC's blanket requirement for institutional approval instead be considered on a case-by-case basis depending on the risk of the research, and perhaps waived for low-risk research where participants are able to provide informed consent, and that universities establish processes to deal with requests from external researchers.</p>","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"317-328"},"PeriodicalIF":1.3,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39786104","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}
{"title":"\"<i>It's Almost as if Stakeholder Engagement is the Annoying 'Have-to-do'…</i>\": Can Ethics Review Help Address the \"3 Ts\" of Tokenism, Toxicity, and Tailoring in Stakeholder Engagement?","authors":"Abigail Wilkinson, Catherine Slack, Siyabonga Thabethe, Jessica Salzwedel","doi":"10.1177/15562646221078415","DOIUrl":"https://doi.org/10.1177/15562646221078415","url":null,"abstract":"<p><p>Ethics guidance recommends that researchers engage stakeholders and that RECs review research for such engagement. The ethics review process may present a unique opportunity to support stakeholder engagement practices for HIV prevention studies. We conducted 28 interviews with experts from 12 countries to explore this issue, and analyzed the data using Thematic Analysis. We found that the value of engagement and review processes was strongly endorsed. However, we identified 3 major thematic complexities, namely: \"Tokenism\" where processes risk being \"tick-box\"; \"Toxicity\", where practices may inadvertently have negative consequences; and \"Tailoring\", where processes need careful variation in intensity. We make recommendations for how these \"Ts\" can be addressed during the review process to help contribute to thoughtful review of meaningful stakeholder engagement in research.</p>","PeriodicalId":520668,"journal":{"name":"Journal of empirical research on human research ethics : JERHRE","volume":" ","pages":"292-303"},"PeriodicalIF":1.3,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/13/ef/10.1177_15562646221078415.PMC9136363.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39799719","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}