{"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":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"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":4,"RegionCategory":"哲学","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":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"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":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Francis Anyaka Amayoa, Frederick Nelson Nakwagala, John Barugahare, Ian Guyton Munabi, Erisa Sabakaki Mwaka
{"title":"Understanding of Critical Elements of Informed Consent in Genomic Research: A Case of a Paediatric HIV-TB Research Project in Uganda.","authors":"Francis Anyaka Amayoa, Frederick Nelson Nakwagala, John Barugahare, Ian Guyton Munabi, Erisa Sabakaki Mwaka","doi":"10.1177/15562646221100430","DOIUrl":"10.1177/15562646221100430","url":null,"abstract":"<p><p>Several studies have reported inadequate comprehension of informed consent for genomic research. This study aimed to assess research participants' understanding of critical elements of informed consent for genomic research. A cross-sectional survey involving 123 parents/caregivers of children participating in a paediatric genomic TB/HIV study was conducted<b>.</b> Only 47.2% of the participants had adequate understanding of consent information. The mean objective (actual) and subjective (perceived) understanding scores were 78.7% and 91.7% respectively. Participants adequately understood most elements of consent however, some elements were poorly understood including foreseeable risks, protection of confidentiality and compensation for research related injury. Overall there was inadequate comprehension of critical elements of informed consent and there was dissonance between actual and perceived comprehension of informed consent.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9398965/pdf/nihms-1802300.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9701489","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}
{"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":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"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":4,"RegionCategory":"哲学","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":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"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":4,"RegionCategory":"哲学","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":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"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":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rasha M Arabyat, Bashar R Qawasmeh, Sayer I Al-Azzam, Mohammad B Nusair, Karem H Alzoubi
{"title":"Faculty Members' Perceptions and Attitudes Towards Anti-Plagiarism Detection Tools: Applying the Theory of Planned Behavior.","authors":"Rasha M Arabyat, Bashar R Qawasmeh, Sayer I Al-Azzam, Mohammad B Nusair, Karem H Alzoubi","doi":"10.1177/15562646221078655","DOIUrl":"https://doi.org/10.1177/15562646221078655","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate predictors of the use of anti-plagiarism detection tools (APTs) in higher education institutions.</p><p><strong>Methods: </strong>An online survey based on the theory of planned behavior was sent to members of science faculties in Jordan. Multivariate Logistic regression was conducted to determine predictors of previous use of APTs, and multivariate linear regression to predict future intentions.</p><p><strong>Results: </strong>A total of 173 faculty members completed the survey, with 78.13% indicating previous APTs use. Turnitin® (43%) and Ithenticate® (32.8%) were the most commonly used APTs. These tools were mainly used to evaluate papers before sending them to journals (65.5%) and to detect plagiarism in theses/dissertations (50.4%). Predictors of previous use were academic rank (p = 0.02) and perceived understanding of APT use (p = 0.043). Intentions for future use were predicted by attitudes (p < 0.001) and perceived behavioral control (p = 0.036).</p><p><strong>Conclusion: </strong>The theory of planned behavior successfully predicted intentions to use APTs. The use of APTs should be encouraged to all faculty members and students.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9992686/pdf/nihms-1870874.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9409624","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}
{"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":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"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":4,"RegionCategory":"哲学","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":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"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":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Erika Blacksher, Susan Brown Trinidad, R Brian Woodbury, Scarlett E Hopkins, Erica L Woodahl, Bert B Boyer, Wylie Burke, Vanessa Hiratsuka
{"title":"Tribal Deliberations about Precision Medicine Research: Addressing Diversity and Inequity in Democratic Deliberation Design and Evaluation.","authors":"Erika Blacksher, Susan Brown Trinidad, R Brian Woodbury, Scarlett E Hopkins, Erica L Woodahl, Bert B Boyer, Wylie Burke, Vanessa Hiratsuka","doi":"10.1177/15562646221081267","DOIUrl":"10.1177/15562646221081267","url":null,"abstract":"<p><p>Deliberative democratic engagement is used around the globe to gather informed public input on contentious collective questions. Yet, rarely has it been used to convene individuals exclusively from Indigenous communities. The relative novelty of using this approach to engage tribal communities and concerns about diversity and inequities raise important methodological questions. We describe the design and quality outcomes for a 2.5-day deliberation that elicited views of American Indian and Alaska Native (AIAN) leaders about the potential value and ethical conduct of precision medicine research (PMR), an emerging approach to research that investigates the health effects of individual genetic variation in tandem with variation in health-relevant practices, social determinants, and environmental exposures. The event met key goals, such as relationship and rapport formation, cross-site learning, equality of opportunity to participate, and respect among participants in the context of disagreement.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9173705/pdf/nihms-1777095.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9463888","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}