Pub Date : 2023-05-22DOI: 10.1177/17470161231174734
B. Daniels, J. Boffa, A. Kwan, S. Moyo
Simulated standardized patients (SPs) are trained individuals who pose incognito as people seeking treatment in a health care setting. With the method’s increasing use and popularity, we propose some standards to adapt the method to contextual considerations of feasibility, and we discuss current issues with the SP method and the experience of consent and ethical research in international SP studies. Since a foundational discussion of the research ethics of the method was published in 2012, a growing number of studies have implemented this method to collect data on the quality of care in a variety of settings around the world. We draw from that experience to provide empirical foundations for a popular approach to ethical approval of such studies in the United States and Canada, which has been to obtain a waiver of informed consent from the health care providers who are the subjects of the research. However, the majority of studies to date have evaluated quality of care outside the U.S., requiring additional ethical consideration when partnering with international institutions. We discuss these considerations in the context of a case study from a completed SP study in South Africa, where informed consent is constitutionally protected.
{"title":"Deception and informed consent in studies with incognito simulated standardized patients: empirical experiences and a case study from South Africa","authors":"B. Daniels, J. Boffa, A. Kwan, S. Moyo","doi":"10.1177/17470161231174734","DOIUrl":"https://doi.org/10.1177/17470161231174734","url":null,"abstract":"Simulated standardized patients (SPs) are trained individuals who pose incognito as people seeking treatment in a health care setting. With the method’s increasing use and popularity, we propose some standards to adapt the method to contextual considerations of feasibility, and we discuss current issues with the SP method and the experience of consent and ethical research in international SP studies. Since a foundational discussion of the research ethics of the method was published in 2012, a growing number of studies have implemented this method to collect data on the quality of care in a variety of settings around the world. We draw from that experience to provide empirical foundations for a popular approach to ethical approval of such studies in the United States and Canada, which has been to obtain a waiver of informed consent from the health care providers who are the subjects of the research. However, the majority of studies to date have evaluated quality of care outside the U.S., requiring additional ethical consideration when partnering with international institutions. We discuss these considerations in the context of a case study from a completed SP study in South Africa, where informed consent is constitutionally protected.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"177 1","pages":"341 - 359"},"PeriodicalIF":1.7,"publicationDate":"2023-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74943045","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 : 2023-04-20DOI: 10.1177/17470161231169205
C. Fournier, S. Stewart, Joshua Adams, Clayton Shirt, Esha Mahabir
Research involving and impacting Indigenous Peoples is often of little or no benefit to the communities involved and, in many cases, causes harm. Ensuring that Indigenous research is not only ethical but also of benefit to the communities involved is a long-standing problem that requires fundamental changes in higher education. To address this necessity for change, the authors of this paper, with the help of graduate and Indigenous community research assistants, undertook community consultation across their university to identify the local and national ethical needs of Indigenous researchers, communities, and Elders. This paper provides an overview of the consultation process, the themes that emerged from the consultations, and a model of the Wholistic Indigenous Research Framework that emerged.
{"title":"Systemic disruptions: decolonizing indigenous research ethics using indigenous knowledges","authors":"C. Fournier, S. Stewart, Joshua Adams, Clayton Shirt, Esha Mahabir","doi":"10.1177/17470161231169205","DOIUrl":"https://doi.org/10.1177/17470161231169205","url":null,"abstract":"Research involving and impacting Indigenous Peoples is often of little or no benefit to the communities involved and, in many cases, causes harm. Ensuring that Indigenous research is not only ethical but also of benefit to the communities involved is a long-standing problem that requires fundamental changes in higher education. To address this necessity for change, the authors of this paper, with the help of graduate and Indigenous community research assistants, undertook community consultation across their university to identify the local and national ethical needs of Indigenous researchers, communities, and Elders. This paper provides an overview of the consultation process, the themes that emerged from the consultations, and a model of the Wholistic Indigenous Research Framework that emerged.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"17 1","pages":"325 - 340"},"PeriodicalIF":1.7,"publicationDate":"2023-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88027013","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 : 2023-04-14DOI: 10.1177/17470161231169484
Mtisunge Isabel Kamlongera, Mkotama W Katenga-Kaunda
This article is autoethnographic, based upon the authors’ experiences and reflections upon encountered moments of ethical tension whilst conducting research in rural Malawi. Given that knowledge production, as a process, has been marred by colonial forms of power, the project was underpinned by efforts to achieve a decolonial approach to the research, including the research ethics. The authors share of their endeavours to counterbalance the challenges of power asymmetries whilst researching and working with an Indigenous community whose reality can be marginalised by the Western canon. The authors attempted to ensure that the values and customs of the researched community were respected and central to the research approach. When researchers are guided by local culture and customs, the participants are able to drive the research approach, incorporate their voice and share knowledge that is true to their context and reality. In this way, the research study is illustrative of how an ethics of care can help to facilitate decolonial research practice.
{"title":"Researchers’ reflections on ethics of care as decolonial research practice: understanding Indigenous knowledge communication systems to navigate moments of ethical tension in rural Malawi","authors":"Mtisunge Isabel Kamlongera, Mkotama W Katenga-Kaunda","doi":"10.1177/17470161231169484","DOIUrl":"https://doi.org/10.1177/17470161231169484","url":null,"abstract":"This article is autoethnographic, based upon the authors’ experiences and reflections upon encountered moments of ethical tension whilst conducting research in rural Malawi. Given that knowledge production, as a process, has been marred by colonial forms of power, the project was underpinned by efforts to achieve a decolonial approach to the research, including the research ethics. The authors share of their endeavours to counterbalance the challenges of power asymmetries whilst researching and working with an Indigenous community whose reality can be marginalised by the Western canon. The authors attempted to ensure that the values and customs of the researched community were respected and central to the research approach. When researchers are guided by local culture and customs, the participants are able to drive the research approach, incorporate their voice and share knowledge that is true to their context and reality. In this way, the research study is illustrative of how an ethics of care can help to facilitate decolonial research practice.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"57 1","pages":"312 - 324"},"PeriodicalIF":1.7,"publicationDate":"2023-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85964180","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 : 2023-04-07DOI: 10.1177/17470161231166600
M. Murdock, Stephanie Erickson
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.
{"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":"12 1","pages":"288 - 311"},"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}
Pub Date : 2023-04-07DOI: 10.1177/17470161231164530
J. Wheeldon, J. Heidt
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.
{"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":"12 1","pages":"250 - 287"},"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}
Pub Date : 2023-04-01Epub Date: 2023-01-12DOI: 10.1177/17470161221148387
David B Resnik
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.
{"title":"Disclosing and Managing Non-Financial Conflicts of Interest in Scientific Publications.","authors":"David B Resnik","doi":"10.1177/17470161221148387","DOIUrl":"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":"19 2","pages":"121-138"},"PeriodicalIF":2.1,"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}
Pub Date : 2023-03-31DOI: 10.1177/17470161231161402
K. Chatfield, E. Dove
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
{"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}
Pub 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
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.
{"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}
Pub Date : 2023-03-23DOI: 10.1177/17470161231157053
S. Rosenfeld, G. Shaler, Ross Hickey
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.
{"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}
Pub Date : 2023-02-25DOI: 10.1177/17470161231159498
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
{"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}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：