Research EthicsPub Date : 2023-04-07DOI: 10.1177/17470161231166600
M. Murdock, Stephanie Erickson
{"title":"Research Responsibility Agreement: a tool to support ethical research","authors":"M. Murdock, Stephanie Erickson","doi":"10.1177/17470161231166600","DOIUrl":"https://doi.org/10.1177/17470161231166600","url":null,"abstract":"When engaging in community-based research, it is important to consider ethical research practices throughout the project. While current research practices require many investigators to obtain approval from an ethics review board before starting a project, more is required to ensure that ethical principles are applied once the investigations begin and after the investigations are complete. In response to this concern, as expressed by workers at a feminist non-profit during a community placement, we developed a tool to foster both greater ethical and feminist research practice in community-based research. Using feminist theories, methodologies, and concepts such as epistemic justice, epistemic trust, and coauthorship, a tool was developed to support researchers and other collaborators in building relationships of reciprocity. This tool, called the Research Responsibility Agreement (RRA) invites all members of a research project to explicitly reflect on their role in the research, their relationships with other collaborators, their responsibility to contributing meaningfully in the project, and their plans to remain accountable to one another. In doing so, the RRA adds to existing tools that support ethical research by sharing explicit reflections from all collaborators on how to prevent harm and by asking them to reflect on ethical practices beyond the initial stages of the project. The RRA also encourages greater engagement from researchers and collaborators toward building meaningful relationships with each other, and with participants, to work together in advancing social change. As a practical tool that promotes reflection, that builds relationships, and that holds all parties accountable to ethical and feminist research practices, the RRA has the potential to generate impactful change in community-based research projects and beyond. While the RRA is tailored to community-based research, it can be applied widely to any research project and has the potential to revolutionize how research relationships are built across disciplines.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84817675","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}
Research EthicsPub Date : 2023-04-07DOI: 10.1177/17470161231164530
J. Wheeldon, J. Heidt
{"title":"Cannabis, research ethics, and a duty of care","authors":"J. Wheeldon, J. Heidt","doi":"10.1177/17470161231164530","DOIUrl":"https://doi.org/10.1177/17470161231164530","url":null,"abstract":"Despite growing evidence to the contrary, researchers continue to posit causal links between cannabis, crime, psychosis, and violence. These spurious connections are rooted in history and fueled decades of structural limitations that shaped how researchers studied cannabis. Until recently, research in this area was explicitly funded to link cannabis use and harm and ignore any potential benefits. Post-prohibition cannabis research has failed to replicate the dire findings of the past. This article outlines how the history of controlling cannabis research has led to various harms, injustices, and ethical complications. We compare commonly cited research from both the prohibition and post-prohibition eras and argue that many popular claims about the dangers of cannabis are the result of ethical lapses by researchers, journals, and funders. We propose researchers in this area adopt a duty of care in cannabis research going forward. This would oblige individual researchers to establish robust research designs, employ careful analytic strategies, and acknowledge limitations in more detail. This duty involves the institutional recognition by funders, journals, and others that cannabis research has been deliberately misconstrued to criminalize, stigmatize, and pathologize.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80705854","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}
Research EthicsPub Date : 2023-04-01DOI: 10.1177/17470161221148387
David B Resnik
{"title":"Disclosing and Managing Non-Financial Conflicts of Interest in Scientific Publications.","authors":"David B Resnik","doi":"10.1177/17470161221148387","DOIUrl":"https://doi.org/10.1177/17470161221148387","url":null,"abstract":"<p><p>In the last decade, there has been increased recognition of the importance of disclosing and managing non-financial conflicts of interests to safeguard the objectivity, integrity, and trustworthiness of scientific research. While funding agencies and academic institutions have had policies for addressing non-financial interests in grant peer review and research oversight since the 1990s, scientific journals have been only recently begun to develop such policies. An impediment to the formulation of effective journal policies is that non-financial interests can be difficult to recognize and define. Journals can overcome this problem by providing guidance concerning the types of non-financial interests that should be disclosed, including direct research interests, direct professional interests, expert testimony, involvement in litigation, holding a leadership position in a non-governmental organization, providing technical or scientific advice to a non-governmental organization, and personal or professional relationships. The guidance should apply to authors, editors, and reviewers.</p>","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10448996/pdf/nihms-1868994.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10106435","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}
Research EthicsPub Date : 2023-03-31DOI: 10.1177/17470161231161402
K. Chatfield, E. Dove
{"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":null,"pages":null},"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}
Research EthicsPub Date : 2023-03-23DOI: 10.1177/17470161231161267
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
{"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":null,"pages":null},"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}
Research EthicsPub Date : 2023-03-23DOI: 10.1177/17470161231157053
S. Rosenfeld, G. Shaler, Ross Hickey
{"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":null,"pages":null},"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}
Research EthicsPub Date : 2023-02-25DOI: 10.1177/17470161231159498
{"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":null,"pages":null},"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}
Research EthicsPub Date : 2023-01-30DOI: 10.1177/17470161231152077
Inés Galende-Domínguez, O. Rivero-Lezcano
{"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":null,"pages":null},"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}
Research EthicsPub Date : 2023-01-12DOI: 10.1177/17470161221147801
E. Dove, C. Douglas
{"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":null,"pages":null},"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}
Research EthicsPub Date : 2023-01-01Epub Date: 2022-10-30DOI: 10.1177/17470161221131497
Lauren R Sankary, Megan E Zelinsky, Paul J Ford, Eric C Blackstone, Robert J Fox
{"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":null,"pages":null},"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}