Pub Date : 2024-01-04DOI: 10.1177/17470161231221258
B. Tang
Scientific research is supposed to acquire or generate knowledge, but such a purpose would be severely undermined by instances of research misconduct (RM) and questionable research practices (QRP). RM and QRP are often framed in terms of moral transgressions by individuals (bad apples) whose aberrant acts could be made conducive by shortcomings in regulatory measures of organizations or institutions (bad barrels). This notion presupposes, to an extent, that the erring parties know exactly what they are doing is wrong and morally culpable, but had nonetheless proceeded to commit wrongful acts. However, a confession of intent to deceived is often not readily admitted by perpetrators of RM. I posit that beyond the simplistic notion of conscious moral transgression, deficits in epistemic virtues and/or the prevalence of epistemic vices have important roles to play in initiating and driving RM/QRP. For the individual perpetrator, deficits in epistemic virtues could lead to or amplify errors in one’s desperate attempt to be accomplished or to excel, and pushes one across the ethical line or down the slippery slope of misconduct. Likewise, a lack of epistemic virtue within perpetrators’ institution or organization could make it conducive for deceitful acts and suppress indications and warning signs for the former. Furthermore, epistemic vices exhibited by reviewers, editors and journals could also promote RM/QRP. In this view, epistemic failings, rather than widespread moral deficiencies of individuals within the research ecosystem, may underlie the prevalence of RM/QRP.
{"title":"Deficient epistemic virtues and prevalence of epistemic vices as precursors to transgressions in research misconduct","authors":"B. Tang","doi":"10.1177/17470161231221258","DOIUrl":"https://doi.org/10.1177/17470161231221258","url":null,"abstract":"Scientific research is supposed to acquire or generate knowledge, but such a purpose would be severely undermined by instances of research misconduct (RM) and questionable research practices (QRP). RM and QRP are often framed in terms of moral transgressions by individuals (bad apples) whose aberrant acts could be made conducive by shortcomings in regulatory measures of organizations or institutions (bad barrels). This notion presupposes, to an extent, that the erring parties know exactly what they are doing is wrong and morally culpable, but had nonetheless proceeded to commit wrongful acts. However, a confession of intent to deceived is often not readily admitted by perpetrators of RM. I posit that beyond the simplistic notion of conscious moral transgression, deficits in epistemic virtues and/or the prevalence of epistemic vices have important roles to play in initiating and driving RM/QRP. For the individual perpetrator, deficits in epistemic virtues could lead to or amplify errors in one’s desperate attempt to be accomplished or to excel, and pushes one across the ethical line or down the slippery slope of misconduct. Likewise, a lack of epistemic virtue within perpetrators’ institution or organization could make it conducive for deceitful acts and suppress indications and warning signs for the former. Furthermore, epistemic vices exhibited by reviewers, editors and journals could also promote RM/QRP. In this view, epistemic failings, rather than widespread moral deficiencies of individuals within the research ecosystem, may underlie the prevalence of RM/QRP.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"19 6","pages":""},"PeriodicalIF":1.7,"publicationDate":"2024-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139387379","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 : 2024-01-03DOI: 10.1177/17470161231223594
Charles Weijer
The COVID-19 pandemic touched off an unprecedented search for vaccines and treatments. Without question, the development of vaccines to prevent COVID-19 was an enormous scientific accomplishment. Further, the RECOVERY and Solidarity trials identified effective treatments for COVID-19. But all was not success. The urgent need for COVID-19 prevention and treatment fueled an embrace of risks—to research participants and to the reliability of the science itself—as allegedly necessary costs to speed scientific progress. Scientists and (even) ethicists supported overturning longstanding norms protecting healthy volunteers in human challenge trials to speed vaccine development, but these trials led to no vaccines. Physicians, with the approval of research ethics committees, designed hundreds of unblinded, single-center clinical trials at high risk of bias to speed the identification of new treatments. But these clinical trials led to no treatments. The lesson for future pandemics is that the acceptance of greater risks to participants or science does not reliably lead to progress. We are better served by science that upholds the highest ethical and methodological standards.
{"title":"COVID-19 human challenge trials and randomized controlled trials: lessons for the next pandemic","authors":"Charles Weijer","doi":"10.1177/17470161231223594","DOIUrl":"https://doi.org/10.1177/17470161231223594","url":null,"abstract":"The COVID-19 pandemic touched off an unprecedented search for vaccines and treatments. Without question, the development of vaccines to prevent COVID-19 was an enormous scientific accomplishment. Further, the RECOVERY and Solidarity trials identified effective treatments for COVID-19. But all was not success. The urgent need for COVID-19 prevention and treatment fueled an embrace of risks—to research participants and to the reliability of the science itself—as allegedly necessary costs to speed scientific progress. Scientists and (even) ethicists supported overturning longstanding norms protecting healthy volunteers in human challenge trials to speed vaccine development, but these trials led to no vaccines. Physicians, with the approval of research ethics committees, designed hundreds of unblinded, single-center clinical trials at high risk of bias to speed the identification of new treatments. But these clinical trials led to no treatments. The lesson for future pandemics is that the acceptance of greater risks to participants or science does not reliably lead to progress. We are better served by science that upholds the highest ethical and methodological standards.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"142 6","pages":""},"PeriodicalIF":1.7,"publicationDate":"2024-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139387473","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 : 2023-12-15DOI: 10.1177/17470161231218173
Jiale Xie, Denise Stockley, Amber Hastings Truelove, Susan Marlin, Rachel Zand, Jennifer Payne, Miranda Miller, Eleftherios K. Soleas
Despite advancements in human research ethics and the growing significance of Research Ethics Board (REB) members, educational opportunities specifically tailored to their needs remain lacking in many countries. In response to this gap, our research aims to understand the demographics, needs, and preferences for educational opportunities of REB members in Canada. We conducted a survey that found REB demographics to be diverse and have different perceptions of their roles on topics such as the evaluation of the scientific merit of studies and responsibilities to stakeholders. We found that REB members in general prefer online tutorials and webinars for their education. Educators interested in facilitating the development of future training programs should consider the needs and preferences of REB members outlined in this publication.
{"title":"Needs and preferences of REB members in the development of a new TCPS 2 training program in Canada","authors":"Jiale Xie, Denise Stockley, Amber Hastings Truelove, Susan Marlin, Rachel Zand, Jennifer Payne, Miranda Miller, Eleftherios K. Soleas","doi":"10.1177/17470161231218173","DOIUrl":"https://doi.org/10.1177/17470161231218173","url":null,"abstract":"Despite advancements in human research ethics and the growing significance of Research Ethics Board (REB) members, educational opportunities specifically tailored to their needs remain lacking in many countries. In response to this gap, our research aims to understand the demographics, needs, and preferences for educational opportunities of REB members in Canada. We conducted a survey that found REB demographics to be diverse and have different perceptions of their roles on topics such as the evaluation of the scientific merit of studies and responsibilities to stakeholders. We found that REB members in general prefer online tutorials and webinars for their education. Educators interested in facilitating the development of future training programs should consider the needs and preferences of REB members outlined in this publication.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"10 1","pages":""},"PeriodicalIF":1.7,"publicationDate":"2023-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138996688","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 : 2023-12-13DOI: 10.1177/17470161231214636
A. Elgamri, Zeinab Mohammed, Karima El-Rhazi, M. Shahrouri, Mamoun Ahram, Al-Mubarak Al-Abbas, Henry Silverman
Arab researchers encounter formidable obstacles when conducting and publishing their scientific work. We conducted semi-structured interviews with 17 Arab researchers from various Arab Middle East countries to gain a comprehensive understanding of the difficulties they face in research and publication. We analyzed the transcripts using reflexive thematic analysis. Our findings revealed several key challenges. First, Arab researchers struggle to conduct high-quality research due to limited resources, inadequate funding, and a lack of a supportive research infrastructure. Furthermore, a shortage of teamwork and mentoring diminishes research productivity. Perverse promotion policies, heavy teaching loads, and low salaries force many researchers to seek external income sources, leaving them with insufficient time for research. Regarding publishing in high-impact journals, Arab researchers confront challenges existing of insufficient scientific writing skills, underrepresentation on editorial boards, and unconscious biases against researchers from economically challenged areas. Finally, achieving research integrity is closely tied to lack of access to essential resources. To address these issues, our participants proposed targeted interventions at the institutional and external levels. For example, universities can implement mentoring programs, offer workshops on scientific writing and publishing, and foster a supportive institutional culture for research. Addressing the underrepresentation of Arabic researchers on editorial boards is crucial for equity in global scientific publishing. In conclusion, acknowledging and addressing these challenges will empower Arab researchers, elevate research quality, and promote equitable global scientific collaboration. Our findings provide guidance for universities, governments, and international donors seeking to enhance research and publication practices in the Arab Middle East.
{"title":"Challenges facing Arab researchers in conducting and publishing scientific research: a qualitative interview study","authors":"A. Elgamri, Zeinab Mohammed, Karima El-Rhazi, M. Shahrouri, Mamoun Ahram, Al-Mubarak Al-Abbas, Henry Silverman","doi":"10.1177/17470161231214636","DOIUrl":"https://doi.org/10.1177/17470161231214636","url":null,"abstract":"Arab researchers encounter formidable obstacles when conducting and publishing their scientific work. We conducted semi-structured interviews with 17 Arab researchers from various Arab Middle East countries to gain a comprehensive understanding of the difficulties they face in research and publication. We analyzed the transcripts using reflexive thematic analysis. Our findings revealed several key challenges. First, Arab researchers struggle to conduct high-quality research due to limited resources, inadequate funding, and a lack of a supportive research infrastructure. Furthermore, a shortage of teamwork and mentoring diminishes research productivity. Perverse promotion policies, heavy teaching loads, and low salaries force many researchers to seek external income sources, leaving them with insufficient time for research. Regarding publishing in high-impact journals, Arab researchers confront challenges existing of insufficient scientific writing skills, underrepresentation on editorial boards, and unconscious biases against researchers from economically challenged areas. Finally, achieving research integrity is closely tied to lack of access to essential resources. To address these issues, our participants proposed targeted interventions at the institutional and external levels. For example, universities can implement mentoring programs, offer workshops on scientific writing and publishing, and foster a supportive institutional culture for research. Addressing the underrepresentation of Arabic researchers on editorial boards is crucial for equity in global scientific publishing. In conclusion, acknowledging and addressing these challenges will empower Arab researchers, elevate research quality, and promote equitable global scientific collaboration. Our findings provide guidance for universities, governments, and international donors seeking to enhance research and publication practices in the Arab Middle East.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"9 1","pages":""},"PeriodicalIF":1.7,"publicationDate":"2023-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139005400","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}
Since its onset, scholars have characterized social media as a valuable source for data collection since it presents several benefits (e.g. exploring research questions with hard-to-reach populations). Nonetheless, methods of online data collection are riddled with ethical and methodological challenges that researchers must consider if they want to adopt good practices when collecting and analyzing online data. Drawing from our primary research project, where we collected passive online data on Reddit, we explore and detail the steps that researchers must consider before collecting online data: (1) planning online data collection; (2) ethical considerations; and (3) data collection. We also discuss two atypical questions that researchers should also consider: (1) how to handle deleted user-generated content; and (2) how to quote user-generated content. Moving on from the dichotomous discussion between what is public and private data, we present recommendations for good practices when collecting and analyzing qualitative online data.
{"title":"Passive data collection on Reddit: a practical approach","authors":"Tiago Rocha-Silva, Conceição Nogueira, Liliana Rodrigues","doi":"10.1177/17470161231210542","DOIUrl":"https://doi.org/10.1177/17470161231210542","url":null,"abstract":"Since its onset, scholars have characterized social media as a valuable source for data collection since it presents several benefits (e.g. exploring research questions with hard-to-reach populations). Nonetheless, methods of online data collection are riddled with ethical and methodological challenges that researchers must consider if they want to adopt good practices when collecting and analyzing online data. Drawing from our primary research project, where we collected passive online data on Reddit, we explore and detail the steps that researchers must consider before collecting online data: (1) planning online data collection; (2) ethical considerations; and (3) data collection. We also discuss two atypical questions that researchers should also consider: (1) how to handle deleted user-generated content; and (2) how to quote user-generated content. Moving on from the dichotomous discussion between what is public and private data, we present recommendations for good practices when collecting and analyzing qualitative online data.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"77 1","pages":""},"PeriodicalIF":1.7,"publicationDate":"2023-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139225196","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}
The purpose of this study was to map the distribution of publications on plagiarism among higher educational institutions in sub-Saharan Africa (SSA). Studies reviewed were based on 171 plagiarism related publications within a decade (2012–2022). Findings revealed that most plagiarism related articles were published in 2016. Additionally, a majority of the studies (53) were from Nigeria and Ghana (23). Most of the articles focused on students’ and faculty’s awareness of plagiarism, and institutional prevention of plagiarism, but were rather marginal on challenges involved in preventing plagiarism, as well as effects of plagiarism. Dominant forms of plagiarism were self-plagiarism, branded plagiarism and commission plagiarism. However, major causes of plagiarism comprised easy access to digital information and resources; poor supervision of students; pressure on academics to publish for promotion; and insufficient skills development regarding ethical academic writing. Additionally, plagiarism preventive software and policies on plagiarism were the main ways of preventing plagiarism. Finally, in fighting plagiarism, higher educational institutions in SSA encountered challenges such as lack of well-trained academic experts to detect and report plagiarism cases; reluctance on the part of technical administrative staff to investigate works for traces of plagiarism; and low plagiarism detection skills from project supervisors. Based on the findings, recommendations are made to stakeholders for future research, policy and practice.
{"title":"Plagiarism in Higher Education (PLAGiHE) within Sub-Saharan Africa: A systematic review of a decade (2012–2022) literature","authors":"Dickson Okoree Mireku, Prosper Dzifa Dzamesi, Brandford Bervell","doi":"10.1177/17470161231189646","DOIUrl":"https://doi.org/10.1177/17470161231189646","url":null,"abstract":"The purpose of this study was to map the distribution of publications on plagiarism among higher educational institutions in sub-Saharan Africa (SSA). Studies reviewed were based on 171 plagiarism related publications within a decade (2012–2022). Findings revealed that most plagiarism related articles were published in 2016. Additionally, a majority of the studies (53) were from Nigeria and Ghana (23). Most of the articles focused on students’ and faculty’s awareness of plagiarism, and institutional prevention of plagiarism, but were rather marginal on challenges involved in preventing plagiarism, as well as effects of plagiarism. Dominant forms of plagiarism were self-plagiarism, branded plagiarism and commission plagiarism. However, major causes of plagiarism comprised easy access to digital information and resources; poor supervision of students; pressure on academics to publish for promotion; and insufficient skills development regarding ethical academic writing. Additionally, plagiarism preventive software and policies on plagiarism were the main ways of preventing plagiarism. Finally, in fighting plagiarism, higher educational institutions in SSA encountered challenges such as lack of well-trained academic experts to detect and report plagiarism cases; reluctance on the part of technical administrative staff to investigate works for traces of plagiarism; and low plagiarism detection skills from project supervisors. Based on the findings, recommendations are made to stakeholders for future research, policy and practice.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"13 1","pages":""},"PeriodicalIF":1.7,"publicationDate":"2023-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76173787","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 : 2023-08-15DOI: 10.1177/17470161231191247
T. Mtande, C. Lombard, G. Nair, S. Rennie
Although the use of the cluster randomized trial (CRT) design to evaluate vaccines, public health interventions or health systems is increasing, the ethical issues posed by the design are not adequately addressed, especially in low- and middle-income country settings (LMICs). To help reveal ethical challenges, qualitative interviews were conducted with key stakeholders experienced in designing and conducting two selected CRTs in Malawi. The 18 interviewed stakeholders included investigators, clinicians, nurses, data management personnel and community workers who were invited to share their experiences related to implementation of CRTs. Data analysis revealed five major themes with ethical implications: (1) The moral obligation for health care providers to participate in health research and its compensation; (2) Suboptimal care services compromising the integrity of CRT; (3) Ensuring scientific validity and withholding care service; (4) Obtaining valid consent and permission for waiver of consent; and (5) Inadequate risk assessment for trial participation. Understanding key ethical issues posed by CRTs in Malawi could improve ethical review and research oversight of this particular study design.
{"title":"Stakeholders’ experiences of ethical challenges in cluster randomized trials in a limited resource setting: a qualitative analysis","authors":"T. Mtande, C. Lombard, G. Nair, S. Rennie","doi":"10.1177/17470161231191247","DOIUrl":"https://doi.org/10.1177/17470161231191247","url":null,"abstract":"Although the use of the cluster randomized trial (CRT) design to evaluate vaccines, public health interventions or health systems is increasing, the ethical issues posed by the design are not adequately addressed, especially in low- and middle-income country settings (LMICs). To help reveal ethical challenges, qualitative interviews were conducted with key stakeholders experienced in designing and conducting two selected CRTs in Malawi. The 18 interviewed stakeholders included investigators, clinicians, nurses, data management personnel and community workers who were invited to share their experiences related to implementation of CRTs. Data analysis revealed five major themes with ethical implications: (1) The moral obligation for health care providers to participate in health research and its compensation; (2) Suboptimal care services compromising the integrity of CRT; (3) Ensuring scientific validity and withholding care service; (4) Obtaining valid consent and permission for waiver of consent; and (5) Inadequate risk assessment for trial participation. Understanding key ethical issues posed by CRTs in Malawi could improve ethical review and research oversight of this particular study design.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"42 1","pages":""},"PeriodicalIF":1.7,"publicationDate":"2023-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82220035","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 : 2023-07-31DOI: 10.1177/17470161231189602
Laura Cooper, K. Johnston, Marie Williams
Many countries, including Australia, have established a national scheme that supports the recognition of a single ethical review for multi-centre research conducted in publicly funded health services. However, local site-specific governance review processes remain decentralised and highly variable. This short report describes the ethics and governance processes required for a negligible risk national survey of physiotherapy-led airway clearance services in Australia. We detail inconsistencies in research governance document preparation and submission (platforms, processes, forms and signatories) and report the time cost and likely impact of these inconsistencies on health services research outcomes. Processes and strategies that facilitated success in this project are identified and summarised as helpful hints to other researchers looking to embark on negligible risk research in public health facilities.
{"title":"Planning a ‘negligible risk’ national health service survey? Counting the cost and strategies for success: a short report","authors":"Laura Cooper, K. Johnston, Marie Williams","doi":"10.1177/17470161231189602","DOIUrl":"https://doi.org/10.1177/17470161231189602","url":null,"abstract":"Many countries, including Australia, have established a national scheme that supports the recognition of a single ethical review for multi-centre research conducted in publicly funded health services. However, local site-specific governance review processes remain decentralised and highly variable. This short report describes the ethics and governance processes required for a negligible risk national survey of physiotherapy-led airway clearance services in Australia. We detail inconsistencies in research governance document preparation and submission (platforms, processes, forms and signatories) and report the time cost and likely impact of these inconsistencies on health services research outcomes. Processes and strategies that facilitated success in this project are identified and summarised as helpful hints to other researchers looking to embark on negligible risk research in public health facilities.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"35 1","pages":""},"PeriodicalIF":1.7,"publicationDate":"2023-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76353285","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 : 2023-07-27DOI: 10.1177/17470161231187099
Kimberley Serpico
The quality of a research study application sends a distinct signal to the institutional review board (IRB) about the skills, capacities, preparation, communication, experience, and resources of its authors. However, efforts to research and define IRB application quality have been insufficient. Inattention to the quality of an IRB application is consequential because the application precedes IRB review, and perceptions of quality between the two may be interrelated and interdependent. Without a clear understanding of quality, IRBs do not know how to define quality and researchers do not know how to achieve quality. This position has not been systematically studied to date, and future research could provide much-needed empirical validation. This paper lays the conceptual groundwork for future investigation into what constitutes quality in an IRB application. It includes a landscape review of multidisciplinary research on quality, as well as a discussion of quality frameworks analogous to research with human participants that exist in the published literature. It also examines the background and significance of federal research regulations, regulatory burdens, researchers’ regulatory literacy, and the roles and responsibilities of IRB professionals within this ecosystem.
{"title":"Defining institutional review board application quality: critical research gaps and future opportunities","authors":"Kimberley Serpico","doi":"10.1177/17470161231187099","DOIUrl":"https://doi.org/10.1177/17470161231187099","url":null,"abstract":"The quality of a research study application sends a distinct signal to the institutional review board (IRB) about the skills, capacities, preparation, communication, experience, and resources of its authors. However, efforts to research and define IRB application quality have been insufficient. Inattention to the quality of an IRB application is consequential because the application precedes IRB review, and perceptions of quality between the two may be interrelated and interdependent. Without a clear understanding of quality, IRBs do not know how to define quality and researchers do not know how to achieve quality. This position has not been systematically studied to date, and future research could provide much-needed empirical validation. This paper lays the conceptual groundwork for future investigation into what constitutes quality in an IRB application. It includes a landscape review of multidisciplinary research on quality, as well as a discussion of quality frameworks analogous to research with human participants that exist in the published literature. It also examines the background and significance of federal research regulations, regulatory burdens, researchers’ regulatory literacy, and the roles and responsibilities of IRB professionals within this ecosystem.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"374 1","pages":""},"PeriodicalIF":1.7,"publicationDate":"2023-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75122564","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 : 2023-07-25DOI: 10.1177/17470161231189843
R. Zur
Pregnancy is a frequently applied exclusion criteria for many forms of research. Common justifications for this exclusion include the potential for teratogenicity, as well as the potential for physiologic changes in pregnancy to impact the research itself. The systematic exclusion of pregnant persons from clinical studies has created a significant gap in knowledge regarding medication safety and efficacy in pregnancy, which continues to cause significant harm to pregnant persons in need of medical therapy. To produce meaningful data and facilitate effective knowledge translation to the clinical setting, special consideration to the pharmacology of pregnancy, as well as to outcomes of concern for this population is essential. The exclusion of pregnant participants from research is not ethically justifiable, as it violates the principles of autonomy, justice and nonmaleficence. While the inclusion of pregnant patients in research presents it’s own challenges, with appropriate methodological, ethical, and clinical considerations, we may be able to narrow the knowledge gap and improve drug availability and safety for pregnant patients and their children.
{"title":"Protected from harm, harmed by protection: ethical consequences of the exclusion of pregnant participants from clinical trials","authors":"R. Zur","doi":"10.1177/17470161231189843","DOIUrl":"https://doi.org/10.1177/17470161231189843","url":null,"abstract":"Pregnancy is a frequently applied exclusion criteria for many forms of research. Common justifications for this exclusion include the potential for teratogenicity, as well as the potential for physiologic changes in pregnancy to impact the research itself. The systematic exclusion of pregnant persons from clinical studies has created a significant gap in knowledge regarding medication safety and efficacy in pregnancy, which continues to cause significant harm to pregnant persons in need of medical therapy. To produce meaningful data and facilitate effective knowledge translation to the clinical setting, special consideration to the pharmacology of pregnancy, as well as to outcomes of concern for this population is essential. The exclusion of pregnant participants from research is not ethically justifiable, as it violates the principles of autonomy, justice and nonmaleficence. While the inclusion of pregnant patients in research presents it’s own challenges, with appropriate methodological, ethical, and clinical considerations, we may be able to narrow the knowledge gap and improve drug availability and safety for pregnant patients and their children.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"21 1","pages":"536 - 545"},"PeriodicalIF":1.7,"publicationDate":"2023-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73739519","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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