Research Ethics最新文献

{"title":"Clarifying our policy on requiring ethics approval in submitted manuscripts","authors":"K. Chatfield, E. Dove","doi":"10.1177/17470161231161402","DOIUrl":"https://doi.org/10.1177/17470161231161402","url":null,"abstract":"Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). Clarifying our policy on requiring ethics approval in submitted manuscripts","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"17 1","pages":"103 - 106"},"PeriodicalIF":1.7,"publicationDate":"2023-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75656423","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":"VIRT2UE: A European train-the-trainer programme for teaching research integrity","authors":"Natalie Evans, Armin Schmolmueller, M. Stolper, Giulia Inguaggiato, Astrid Hooghiemstra, Ružica Tokalić, D. Pizzolato, Nicole Foeger, A. Marušić, Marc van Hoof, D. Lanzerath, B. Molewijk, K. Dierickx, Guy Widdershoven on","doi":"10.1177/17470161231161267","DOIUrl":"https://doi.org/10.1177/17470161231161267","url":null,"abstract":"Universities and other research institutions are increasingly providing additional training in research integrity to improve the quality and reliability of research. Various training courses have been developed, with diverse learning goals and content. Despite the importance of training that focuses on moral character and professional virtues, there remains a lack of training that adopts a virtue ethics approach. To address this, we, a European Commission-funded consortium, have designed a train-the-trainer programme for research integrity. The programme is based on (1) virtue ethics, (2) the ethos of science, (3) learning by doing and (4) learner-centred teaching. The blended learning programme combines e-learning modules with participatory group sessions. Trainers are taught how to guide researchers through a series of structured exercises for fostering reflection on scientific virtues, and how to promote understanding and application of the European Code of Conduct for Research Integrity. Trainers are provided with adaptable tools and resources that can be used and combined in different ways. The programme implementation began in Spring 2020 and 470 trainers have participated to date. When trainers were asked to grade – between 0 (very bad) and 10 (excellent) – the e-learning modules and the participatory exercises, 60% scored a grade 8 or higher (median = 8, IQR = 2) for the e-learning modules, whereas 80% scored a grade 8 or higher (median = 9, IQR = 1) for the participatory exercises. A majority felt that the training helped them as a trainer to learn about ways to organise and teach a research integrity course (82%) and would recommend the interactive exercises to others (92%). Trainers have educated over 3300 researchers in Europe using our virtue-based approach. The VIRT2UE train-the-trainer programme fosters research integrity by providing trainers with exercises and tools which enable them to stimulate the development of good researchers across Europe.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"2015 1","pages":""},"PeriodicalIF":1.7,"publicationDate":"2023-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86894321","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 Harraseeket Conference – Revisiting systems for ethics oversight of research with human participants","authors":"S. Rosenfeld, G. Shaler, Ross Hickey","doi":"10.1177/17470161231157053","DOIUrl":"https://doi.org/10.1177/17470161231157053","url":null,"abstract":"The current system of ethical oversight in the United States is based on Institutional Review Board (IRB) review. The system was established in response to well-known and egregious mistreatment of subjects in both biomedical and social and behavioral research. In the decades since the research regulations were enacted, reaction to the burden of IRB oversight has led the system to focus on compliance and limit its active oversight disproportionately to studies that could present the risk of physical harm. At the same time, the characteristics of the research enterprise have changed and methodologies now present novel risks that were not envisioned in the regulations. We convened a group of IRB professionals, academic leaders, and others to discuss limitations of the current system, how that system could be changed to recognize evolving risks and an increasing focus on participant and community voice, and how it could better serve the needs of researchers and support the societal project of science as a public good. Recommendations included a call to reexamine the academic incentive structure, to develop a system to support consideration of ethical principles from the time of study design, and to explicitly provide different ethical support and oversight for high-risk interventional trials and lower risk biomedical and social behavioral research.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"44 1","pages":"231 - 249"},"PeriodicalIF":1.7,"publicationDate":"2023-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81642842","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":"Correction Statement: Conflict of Interest Statements","authors":"","doi":"10.1177/17470161231159498","DOIUrl":"https://doi.org/10.1177/17470161231159498","url":null,"abstract":"Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). Correction Statement: Conflict of Interest Statements","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"45 1","pages":"360 - 367"},"PeriodicalIF":1.7,"publicationDate":"2023-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74917727","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":"Ethical considerations about the collection of biological samples for genetic analysis in clinical trials","authors":"Inés Galende-Domínguez, O. Rivero-Lezcano","doi":"10.1177/17470161231152077","DOIUrl":"https://doi.org/10.1177/17470161231152077","url":null,"abstract":"Progress in precision medicine is being achieved through the design of clinical trials that use genetic biomarkers to guide stratification of patients and assignation to treatment or control groups. Genetic analysis of biomarkers is, therefore, essential to complete their objectives, and this involves the study of biological samples from donor patients that have been recruited according to criteria previously established in the design of the clinical trial. Nevertheless, it is becoming very common that, in the solicitation of biological samples, purposes that are beyond the objectives of the stated therapeutic trial research are introduced, like the development of ill-explained exploratory studies or the use in unspecified future research. In the digital era, the sequencing of patients’ DNA needs to be considered as a serious security matter, not only for the patients, but also for their relatives. Genetic information may be easily stored, even forever, in digital files. This engenders a permanent risk of being stolen or misused in many ways. Furthermore, re-identification of sample donors is technically feasible through their genetic data. For these reasons, genetic analysis of samples collected in clinical trials should be restricted to the accomplishment of their main objectives or well justified goals.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"10 1","pages":"220 - 226"},"PeriodicalIF":1.7,"publicationDate":"2023-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87527667","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":"Ethics governance in Scottish universities: how can we do better? A qualitative study","authors":"E. Dove, C. Douglas","doi":"10.1177/17470161221147801","DOIUrl":"https://doi.org/10.1177/17470161221147801","url":null,"abstract":"While ethical norms for conducting academic research in the United Kingdom are relatively clear, there is little empirical understanding of how university research ethics committees (RECs) themselves operate and whether they are seen to operate well. In this article, we offer insights from a project focused on the Scottish university context. We deployed a three-sided qualitative approach: (i) document analysis; (ii) interviews with REC members, administrators, and managers; and (iii) direct observation of REC meetings. We found that RECs have diverse operation and vary in terms of what members understand to be the remit of their REC and what should constitute the content of ethics review. Overall, though, most participants perceive university RECs as operating well. When asked what they consider to be areas for further improvement, most commented on: implementation of an online system; more experience with how to evaluate various kinds of research projects; best practice exchange and training opportunities; more accurate reflection of the REC role as part of the university’s workload allocation model; and greater recognition of the importance of research ethics governance in the university’s research environment, and, for the members themselves, their career advancement. Based on our findings and subsequent discussions during an end-of-project roundtable with stakeholders, we propose a model of collaboration that can address some of the identified areas that could benefit from further improvement. This model would facilitate a heightened awareness of the importance of supporting REC members in their own effort in assisting students and staff alike in undertaking as ethically robust research as possible.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"40 1","pages":"166 - 198"},"PeriodicalIF":1.7,"publicationDate":"2023-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84745680","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":"Overcoming barriers to informed consent in neurological research: Perspectives from a national survey.","authors":"Lauren R Sankary, Megan E Zelinsky, Paul J Ford, Eric C Blackstone, Robert J Fox","doi":"10.1177/17470161221131497","DOIUrl":"10.1177/17470161221131497","url":null,"abstract":"<p><p>The ethical recruitment of participants with neurological disorders in clinical research requires obtaining initial and ongoing informed consent. The purpose of this study is to characterize barriers faced by research personnel in obtaining informed consent from research participants with neurological disorders and to identify strategies applied by researchers to overcome those barriers. This study was designed as a web-based survey of US researchers with an optional follow-up interview. A subset of participants who completed the survey were selected using a stratified purposeful sampling strategy and invited to participate in an in-depth qualitative interview by phone or video conference. Data were analyzed using a mixed methods approach, including content analysis of survey responses and thematic analysis of interview responses. Over 1 year, 113 survey responses were received from US research personnel directly involved in obtaining informed consent from participants in neurological research. Frequently identified barriers to informed consent included: cognitive and communication impairments (e.g. aphasia), unrealistic expectations of research participants, mistrust of medical research, time constraints, literacy barriers, lack of available social support, and practical or resource-related constraints. Strategies to enhance informed consent included: involving close others to support participant understanding of study-related information, collaborating with more experienced research personnel to facilitate training in obtaining informed consent, encouraging participants to review consent forms in advance of consent discussions, and using printed materials and visual references. Beyond conveying study-related information, researchers included in this study endorsed ethical responsibilities to support deliberation necessary to informed consent in the context of misconceptions about research, unrealistic expectations, limited understanding, mistrust, and/or pressure from close others. Findings highlight the importance of training researchers involved in obtaining informed consent in neurological research to address disease-specific challenges and to support the decision-making processes of potential research participants and their close others.</p>","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"19 1","pages":"42-61"},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10609656/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71414490","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":"Journal editors and publishers’ legal obligations with respect to medical research misconduct","authors":"Naomi Holbeach, Ian Freckelton Ao Qc, Bency Mol","doi":"10.1177/17470161221147440","DOIUrl":"https://doi.org/10.1177/17470161221147440","url":null,"abstract":"As the burden of misconduct in medical research is increasingly recognised, questions have been raised about how best to address this problem. Whilst there are existing mechanisms for the investigation and management of misconduct in medical literature, they are inadequate to deal with the magnitude of the problem. Journal editors and publishers play an essential role in protecting the veracity of the medical literature. Whilst ethical guidance for journal editors and publishers is important, it is not as readily enforceable as legal obligations might be. This article questions the legal obligations that might exist for journal editors and publishing companies with respect to ensuring the veracity of the published literature. Ultimately, there is no enforceable legal obligation in Australia, the United Kingdom, or the United States. In light of this, more robust mechanisms are needed to deliver greater confidence and transparency in the investigative process, the management of concerns or findings of misconduct and the need to cleanse the literature. We show that the law disincentivises journals and publishers from ensuring truth in their publications. There are harmful consequences for medical care and public confidence in the medical profession and health care system when the foundations of medical science are questionable.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"37 1","pages":"107 - 120"},"PeriodicalIF":1.7,"publicationDate":"2022-12-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79087945","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 ethics review and the humanities and social sciences: disciplinary distinctions in ethics review processes","authors":"Jessica Carniel, A. Hickey, Kim Southey, Annette Brömdal, Lynda Crowley-Cyr, Douglas C. Eacersall, William F Farmer, R. Gehrmann, T. Machin, Yosheen Pillay","doi":"10.1177/17470161221147202","DOIUrl":"https://doi.org/10.1177/17470161221147202","url":null,"abstract":"Ethics review processes are frequently perceived as extending from codes and protocols rooted in biomedical disciplines. As a result, many researchers in the humanities and social sciences (HASS) find these processes to be misaligned, if not outrightly obstructive to their research. This leads some scholars to advocate against HASS participation in institutional review processes as they currently stand, or in their entirety. While ethics review processes can present a challenge to HASS researchers, these are not insurmountable and, in fact, present opportunities for ethics review boards (ERBs) to mediate their practices to better attend to the concerns of the HASS disciplines. By highlighting the potential value of the ethics review process in recognising the nuances and specificity across different forms of research, this article explores the generative possibilities of greater collaboration between HASS researchers and ERBs. Remaining cognisant of the epistemic and methodological differences that mark different disciplinary formations in turn will benefit the ethical conduct of all researchers.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"22 1","pages":"139 - 156"},"PeriodicalIF":1.7,"publicationDate":"2022-12-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83116617","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":"Promising practices and constraining factors in mobilizing community-engaged research","authors":"Michelle Lam, Akech Mayuom","doi":"10.1177/17470161221141275","DOIUrl":"https://doi.org/10.1177/17470161221141275","url":null,"abstract":"This article describes a project involving 13 community focus groups on the topic of anti-racism and belonging where the researchers concluded each group with a robust discussion about how the group would prefer to receive the findings from the project. Analysis of this data, existing literature, and the practical experiences of the researchers revealed that while there are multiple “bridges” researchers can take to connect their research with community-level users, and although it is desirable to offer tailored approaches for specific audiences, there are significant barriers and challenges for truly effective engagement. By describing the various factors that determined which bridges were taken, we hope to help other community-based researchers imagine new ways of mobilizing knowledge, consider promising practices to guide the connection of knowledge to the community and shine a light on the very real constraints of time, budget, personnel, and university system considerations that impact knowledge mobilization decisions.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"39 1","pages":"199 - 219"},"PeriodicalIF":1.7,"publicationDate":"2022-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76839692","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}