Pub Date : 2024-03-28DOI: 10.1177/17470161241241409
Melanie Arnold, Stacie Merritt, Kathryn Mears, Anna Bryan, Jane Bryce
This article describes our efforts to screen and enrol clinical trial participants conscientiously in the COVID-19 pandemic setting. We present the standard screening and enrolment process prior to, and our process of adapting to, the pandemic. Our goal was to develop a way to screen and enrol people for clinical trials that was both equitable and effective. In addition, we outline the steps our research department took to ensure that ethical, clinical and logistical factors were considered when matching a patient to a clinical trial.
{"title":"Conscientious enrolment in clinical trials during the COVID-19 pandemic: right patient, right trial","authors":"Melanie Arnold, Stacie Merritt, Kathryn Mears, Anna Bryan, Jane Bryce","doi":"10.1177/17470161241241409","DOIUrl":"https://doi.org/10.1177/17470161241241409","url":null,"abstract":"This article describes our efforts to screen and enrol clinical trial participants conscientiously in the COVID-19 pandemic setting. We present the standard screening and enrolment process prior to, and our process of adapting to, the pandemic. Our goal was to develop a way to screen and enrol people for clinical trials that was both equitable and effective. In addition, we outline the steps our research department took to ensure that ethical, clinical and logistical factors were considered when matching a patient to a clinical trial.","PeriodicalId":510000,"journal":{"name":"Research Ethics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140371863","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}
Pub Date : 2024-03-28DOI: 10.1177/17470161241240594
Maya Peled-Raz, Yael Efron, S. Tzafrir, I. Doron, G. Enosh
Although well established in developed countries, Ethics review boards in the academia, and specifically for social and behavioral sciences (SBS) research, is a relatively new, and still a controversy inducing endeavor. This study explores the establishment and functioning of ERBs in Israeli academia, serving as a case study for the challenges and progress made in ensuring ethical research practices in non-medical related spheres. A purposeful sample of 46 participants was selected, comprising ERB current or past members and SBS researchers, who each interacted extensively with ERB’s evaluation processes. The participants came from all eight research universities of Israel, as well as seven large public and private academic colleges. Open, semi structured In-depth interviews were conducted in order to facilitate a critical reflective stance among the various participants, exploring their experiences, behaviors and the meanings they assign to ERB processes. Our research revealed two major themes. The first is the developmental trajectories in the construction processes of ERBs in Israel, comprised of the following stages: Initiation, expansion, opposition, and acceptance and assimilation. The second was a typology of participation throughout the ERBs’ construction process. Inspired by Merton’s strain theory, this typology includes conformists, ritualists, ideologists, control-freaks, and insurgents. The findings expose a unique perspective into the initiation, establishment, and development of ERBs, which can shed light on the role of ERBs in general, as well as point out how resistance to ERBs, as well as the different reasons for championing them, affected not only ERBs form and their legitimacy, but also their interaction with researchers.
{"title":"The development and evolution of ethics review boards – Israel as a case study","authors":"Maya Peled-Raz, Yael Efron, S. Tzafrir, I. Doron, G. Enosh","doi":"10.1177/17470161241240594","DOIUrl":"https://doi.org/10.1177/17470161241240594","url":null,"abstract":"Although well established in developed countries, Ethics review boards in the academia, and specifically for social and behavioral sciences (SBS) research, is a relatively new, and still a controversy inducing endeavor. This study explores the establishment and functioning of ERBs in Israeli academia, serving as a case study for the challenges and progress made in ensuring ethical research practices in non-medical related spheres. A purposeful sample of 46 participants was selected, comprising ERB current or past members and SBS researchers, who each interacted extensively with ERB’s evaluation processes. The participants came from all eight research universities of Israel, as well as seven large public and private academic colleges. Open, semi structured In-depth interviews were conducted in order to facilitate a critical reflective stance among the various participants, exploring their experiences, behaviors and the meanings they assign to ERB processes. Our research revealed two major themes. The first is the developmental trajectories in the construction processes of ERBs in Israel, comprised of the following stages: Initiation, expansion, opposition, and acceptance and assimilation. The second was a typology of participation throughout the ERBs’ construction process. Inspired by Merton’s strain theory, this typology includes conformists, ritualists, ideologists, control-freaks, and insurgents. The findings expose a unique perspective into the initiation, establishment, and development of ERBs, which can shed light on the role of ERBs in general, as well as point out how resistance to ERBs, as well as the different reasons for championing them, affected not only ERBs form and their legitimacy, but also their interaction with researchers.","PeriodicalId":510000,"journal":{"name":"Research Ethics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140372887","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}
Pub Date : 2024-03-20DOI: 10.1177/17470161241239791
Kadri Simm, Mari-Liisa Parder, Anu Tammeleht, Kadri Lees
While empirical studies of research ethics and integrity are increasingly common, few have aimed at national scope, and even fewer at current results from Central and Eastern Europe. This article introduces the results of the first national research integrity survey in Estonia, which included all research-performing organisations in Estonia, was inclusive of all disciplines and all levels of experience. A web-based survey was developed and carried out in Estonia with a call sent to all accredited Estonian research institutions. The results indicate that the vast majority (89%) of respondents consider research ethics and integrity issues important and view falsification, fabrication, and plagiarism (FFPs) as the most severe forms of misconduct. Self-reporting of FFPs is generally comparable to levels published in other studies (6.2%). Gift authorship (41%) and hampering the work of a colleague (32%) were problematic practices most noticed among colleagues. At the same time, two of the noticed questionable research practices (QRPs) – salami-slicing and misuse of research funding – were seen as less severe, hinting at the existence of counter-norms that career advancement rules and structural factors like funding policies may encourage. The availability of research ethics and integrity guidelines was considered good. Ethical aspects of studying potentially stigmatising data in a very small research community are discussed in the article and results are analysed through counter-norms and normative dissonance frames.
{"title":"National cross-disciplinary research ethics and integrity study: methodology and results from Estonia","authors":"Kadri Simm, Mari-Liisa Parder, Anu Tammeleht, Kadri Lees","doi":"10.1177/17470161241239791","DOIUrl":"https://doi.org/10.1177/17470161241239791","url":null,"abstract":"While empirical studies of research ethics and integrity are increasingly common, few have aimed at national scope, and even fewer at current results from Central and Eastern Europe. This article introduces the results of the first national research integrity survey in Estonia, which included all research-performing organisations in Estonia, was inclusive of all disciplines and all levels of experience. A web-based survey was developed and carried out in Estonia with a call sent to all accredited Estonian research institutions. The results indicate that the vast majority (89%) of respondents consider research ethics and integrity issues important and view falsification, fabrication, and plagiarism (FFPs) as the most severe forms of misconduct. Self-reporting of FFPs is generally comparable to levels published in other studies (6.2%). Gift authorship (41%) and hampering the work of a colleague (32%) were problematic practices most noticed among colleagues. At the same time, two of the noticed questionable research practices (QRPs) – salami-slicing and misuse of research funding – were seen as less severe, hinting at the existence of counter-norms that career advancement rules and structural factors like funding policies may encourage. The availability of research ethics and integrity guidelines was considered good. Ethical aspects of studying potentially stigmatising data in a very small research community are discussed in the article and results are analysed through counter-norms and normative dissonance frames.","PeriodicalId":510000,"journal":{"name":"Research Ethics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140388346","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}
Pub Date : 2024-03-04DOI: 10.1177/17470161241234502
Robin Coningham, N. Lewer, K. P. Acharya, Kai Weise, R. B. Kunwar, Anie Joshi, Sandhya Parajuli Khanal
The earthquakes which struck Nepal’s capital in 2015 were humanitarian disasters. Not only did they inflict tragic loss of life and livelihoods, they also destroyed parts of the Kathmandu Valley’s unique UNESCO World Heritage site. These monuments were not just ornate structures but living monuments playing central roles in the daily lives of thousands, representing portals where the heavens touch earth and people commune with guiding deities. Their rehabilitation was also of economic importance as they represent a major source of tourist income and employment. Unfortunately, the social and political desire for rapid reconstruction resulted in the swift removal of many traditionally constructed foundations and their replacement with modern materials without assessments of whether they contributed towards the collapse of individual monuments. These actions, combined with the wholesale removal, mixing and dumping of modern and historic debris, contributed to a second, equally destructive, cultural catastrophe – irreversible damage to Kathmandu’s Medieval fabric, in a process which frequently excluded local communities and custodians. This case study draws from our collective reflections and lessons learned from our attempts to enable equitable and ethical research partnerships between UK and Nepali colleagues as well as local communities in the debris of the Kasthamandap, Kathmandu’s eponymous monument. After briefly describing the potential of mobilising archaeologists in post-disaster contexts and outlining the challenges of undertaking research in such a setting, our case study utilises the TRUST Code to assess the character and success of our multidisciplinary collaboration in a time of crises.
{"title":"Enabling equitable and ethical research partnerships in crisis situations: Lessons learned from post-disaster heritage protection interventions following Nepal’s 2015 earthquake","authors":"Robin Coningham, N. Lewer, K. P. Acharya, Kai Weise, R. B. Kunwar, Anie Joshi, Sandhya Parajuli Khanal","doi":"10.1177/17470161241234502","DOIUrl":"https://doi.org/10.1177/17470161241234502","url":null,"abstract":"The earthquakes which struck Nepal’s capital in 2015 were humanitarian disasters. Not only did they inflict tragic loss of life and livelihoods, they also destroyed parts of the Kathmandu Valley’s unique UNESCO World Heritage site. These monuments were not just ornate structures but living monuments playing central roles in the daily lives of thousands, representing portals where the heavens touch earth and people commune with guiding deities. Their rehabilitation was also of economic importance as they represent a major source of tourist income and employment. Unfortunately, the social and political desire for rapid reconstruction resulted in the swift removal of many traditionally constructed foundations and their replacement with modern materials without assessments of whether they contributed towards the collapse of individual monuments. These actions, combined with the wholesale removal, mixing and dumping of modern and historic debris, contributed to a second, equally destructive, cultural catastrophe – irreversible damage to Kathmandu’s Medieval fabric, in a process which frequently excluded local communities and custodians. This case study draws from our collective reflections and lessons learned from our attempts to enable equitable and ethical research partnerships between UK and Nepali colleagues as well as local communities in the debris of the Kasthamandap, Kathmandu’s eponymous monument. After briefly describing the potential of mobilising archaeologists in post-disaster contexts and outlining the challenges of undertaking research in such a setting, our case study utilises the TRUST Code to assess the character and success of our multidisciplinary collaboration in a time of crises.","PeriodicalId":510000,"journal":{"name":"Research Ethics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140080141","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}
Pub Date : 2024-02-24DOI: 10.1177/17470161241235910
Hugh T Davies, S. Kolstoe, Anthony Lockett
Valid consent requires the potential research participant understands the information provided. We examined current practice in 50 proposed Clinical Trials of Investigational Medicinal Products to determine how this understanding is checked. The majority of the proposals ( n = 44) indicated confirmation of understanding would take place during an interactive conversation between the researcher and potential participant, containing questions to assess and establish understanding. Yet up until now, research design and review have not focussed upon this, concentrating more on written material. We propose ways this interactive conversation can be documented, and the process of checking understanding improved.
{"title":"Reshaping consent so we might improve participant choice (III) – How is the research participant’s understanding currently checked and how might we improve this process?","authors":"Hugh T Davies, S. Kolstoe, Anthony Lockett","doi":"10.1177/17470161241235910","DOIUrl":"https://doi.org/10.1177/17470161241235910","url":null,"abstract":"Valid consent requires the potential research participant understands the information provided. We examined current practice in 50 proposed Clinical Trials of Investigational Medicinal Products to determine how this understanding is checked. The majority of the proposals ( n = 44) indicated confirmation of understanding would take place during an interactive conversation between the researcher and potential participant, containing questions to assess and establish understanding. Yet up until now, research design and review have not focussed upon this, concentrating more on written material. We propose ways this interactive conversation can be documented, and the process of checking understanding improved.","PeriodicalId":510000,"journal":{"name":"Research Ethics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140435249","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}
Pub Date : 2024-02-05DOI: 10.1177/17470161231224481
K. Chatfield, Emma Law
Evidence suggests that the incidence of research misconduct is not in decline despite efforts to improve awareness, education and governance mechanisms. Two responses to this problem are favoured: first, the promotion of an agent-centred ethics approach to enhance researchers’ personal responsibility and accountability, and second, a change in research culture to relieve perceived pressures to engage in misconduct. This article discusses the challenges for both responses and explains how normative coherence through values alignment might assist. We argue that research integrity and research ethics convey mixed messages, which are likely to contribute to a form of normative confusion. For the successful adoption of an agent-centred approach, normative coherence is needed between the two. To facilitate normative coherence, we propose that research ethics and research integrity be underpinned by a shared set of moral values that can be enacted via codes and guidelines and imbue research environments. Furthermore, to facilitate culture change, the same normative coherence is necessary at all levels of an institution. Only via values alignment between institutional aims, management, institutional practices and researchers can an ethical culture become truly embedded in research institutions.
{"title":"‘I should do what?’ Addressing research misconduct through values alignment","authors":"K. Chatfield, Emma Law","doi":"10.1177/17470161231224481","DOIUrl":"https://doi.org/10.1177/17470161231224481","url":null,"abstract":"Evidence suggests that the incidence of research misconduct is not in decline despite efforts to improve awareness, education and governance mechanisms. Two responses to this problem are favoured: first, the promotion of an agent-centred ethics approach to enhance researchers’ personal responsibility and accountability, and second, a change in research culture to relieve perceived pressures to engage in misconduct. This article discusses the challenges for both responses and explains how normative coherence through values alignment might assist. We argue that research integrity and research ethics convey mixed messages, which are likely to contribute to a form of normative confusion. For the successful adoption of an agent-centred approach, normative coherence is needed between the two. To facilitate normative coherence, we propose that research ethics and research integrity be underpinned by a shared set of moral values that can be enacted via codes and guidelines and imbue research environments. Furthermore, to facilitate culture change, the same normative coherence is necessary at all levels of an institution. Only via values alignment between institutional aims, management, institutional practices and researchers can an ethical culture become truly embedded in research institutions.","PeriodicalId":510000,"journal":{"name":"Research Ethics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139802672","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}
Pub Date : 2024-02-05DOI: 10.1177/17470161231224481
K. Chatfield, Emma Law
Evidence suggests that the incidence of research misconduct is not in decline despite efforts to improve awareness, education and governance mechanisms. Two responses to this problem are favoured: first, the promotion of an agent-centred ethics approach to enhance researchers’ personal responsibility and accountability, and second, a change in research culture to relieve perceived pressures to engage in misconduct. This article discusses the challenges for both responses and explains how normative coherence through values alignment might assist. We argue that research integrity and research ethics convey mixed messages, which are likely to contribute to a form of normative confusion. For the successful adoption of an agent-centred approach, normative coherence is needed between the two. To facilitate normative coherence, we propose that research ethics and research integrity be underpinned by a shared set of moral values that can be enacted via codes and guidelines and imbue research environments. Furthermore, to facilitate culture change, the same normative coherence is necessary at all levels of an institution. Only via values alignment between institutional aims, management, institutional practices and researchers can an ethical culture become truly embedded in research institutions.
{"title":"‘I should do what?’ Addressing research misconduct through values alignment","authors":"K. Chatfield, Emma Law","doi":"10.1177/17470161231224481","DOIUrl":"https://doi.org/10.1177/17470161231224481","url":null,"abstract":"Evidence suggests that the incidence of research misconduct is not in decline despite efforts to improve awareness, education and governance mechanisms. Two responses to this problem are favoured: first, the promotion of an agent-centred ethics approach to enhance researchers’ personal responsibility and accountability, and second, a change in research culture to relieve perceived pressures to engage in misconduct. This article discusses the challenges for both responses and explains how normative coherence through values alignment might assist. We argue that research integrity and research ethics convey mixed messages, which are likely to contribute to a form of normative confusion. For the successful adoption of an agent-centred approach, normative coherence is needed between the two. To facilitate normative coherence, we propose that research ethics and research integrity be underpinned by a shared set of moral values that can be enacted via codes and guidelines and imbue research environments. Furthermore, to facilitate culture change, the same normative coherence is necessary at all levels of an institution. Only via values alignment between institutional aims, management, institutional practices and researchers can an ethical culture become truly embedded in research institutions.","PeriodicalId":510000,"journal":{"name":"Research Ethics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139862353","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}
Pub Date : 2024-01-09DOI: 10.1177/17470161231224552
V. Mollaki
Peer review facilitates quality control and integrity of scientific research. Although publishing policies have adapted to include the use of Artificial Intelligence (AI) tools, such as Chat Generative Pre-trained Transformer (ChatGPT), in the preparation of manuscripts by authors, there is a lack of guidelines or policies on whether peer reviewers can use such tools. The present article highlights the lack of policies on the use of AI tools in the peer review process (PRP) and argues that we need to go beyond policies by creating transparent procedures that will enable journals to investigate allegations of non-compliance and take decisions that will protect the integrity of the peer review system. Reviewers found to violate relevant policies must be excluded from the process to safeguard the integrity of the peer review system.
{"title":"Death of a reviewer or death of peer review integrity? the challenges of using AI tools in peer reviewing and the need to go beyond publishing policies","authors":"V. Mollaki","doi":"10.1177/17470161231224552","DOIUrl":"https://doi.org/10.1177/17470161231224552","url":null,"abstract":"Peer review facilitates quality control and integrity of scientific research. Although publishing policies have adapted to include the use of Artificial Intelligence (AI) tools, such as Chat Generative Pre-trained Transformer (ChatGPT), in the preparation of manuscripts by authors, there is a lack of guidelines or policies on whether peer reviewers can use such tools. The present article highlights the lack of policies on the use of AI tools in the peer review process (PRP) and argues that we need to go beyond policies by creating transparent procedures that will enable journals to investigate allegations of non-compliance and take decisions that will protect the integrity of the peer review system. Reviewers found to violate relevant policies must be excluded from the process to safeguard the integrity of the peer review system.","PeriodicalId":510000,"journal":{"name":"Research Ethics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139444070","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}
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