Pub Date : 2022-06-14DOI: 10.1177/17470161221106674
Ali Ibrahim Mohammed-Ali, E. I. Gebremeskel, E. Yenshu, T. Nji, Apungwa Cornelius Ntabe, S. Wanji, G. Tangwa, N. S. Munung
Concerns around comprehension and recall of consent information by research participants have typically been associated with low health and research literacy levels. In genomics research, this concern is heightened as the scientific and ethical complexities of genetics research, such as biobanking, genetic susceptibility, data sharing, and incidental findings may be more difficult for potential research participants to understand. However, challenges to research participants’ comprehension of consent information may be compounded by factors beyond health and research literacy levels. To identify factors that may impact research participants’ understanding and recall of consent information, we designed a qualitative study to explore whether participants enrolled in a tuberculosis genetics study (TBGEN-Africa) in Cameroon understood the objectives of the study, the risks and benefits and certain key aspects of the study such as biobanking and data sharing. The results showed that research participants had limited understanding and/or recall of the TBGEN-Africa study goals and methods. Some participants were of the opinion that TBGEN-Africa was not a genetics study because tuberculosis is not an inheritable condition. Factors that may have hindered understanding and/or recall of study information are diagnostic misconception (research participants consider research as part of medical diagnosis), and information overload and situational vulnerability (consent at a time of physical and emotional distress). There is a need for improved practices to support research participants’ understanding of consent information in genetics studies including designing the consent process in ways that minimize psychological distress and diagnostic/therapeutic misconception.
{"title":"Informed consent in a tuberculosis genetic study in Cameroon: information overload, situational vulnerability and diagnostic misconception","authors":"Ali Ibrahim Mohammed-Ali, E. I. Gebremeskel, E. Yenshu, T. Nji, Apungwa Cornelius Ntabe, S. Wanji, G. Tangwa, N. S. Munung","doi":"10.1177/17470161221106674","DOIUrl":"https://doi.org/10.1177/17470161221106674","url":null,"abstract":"Concerns around comprehension and recall of consent information by research participants have typically been associated with low health and research literacy levels. In genomics research, this concern is heightened as the scientific and ethical complexities of genetics research, such as biobanking, genetic susceptibility, data sharing, and incidental findings may be more difficult for potential research participants to understand. However, challenges to research participants’ comprehension of consent information may be compounded by factors beyond health and research literacy levels. To identify factors that may impact research participants’ understanding and recall of consent information, we designed a qualitative study to explore whether participants enrolled in a tuberculosis genetics study (TBGEN-Africa) in Cameroon understood the objectives of the study, the risks and benefits and certain key aspects of the study such as biobanking and data sharing. The results showed that research participants had limited understanding and/or recall of the TBGEN-Africa study goals and methods. Some participants were of the opinion that TBGEN-Africa was not a genetics study because tuberculosis is not an inheritable condition. Factors that may have hindered understanding and/or recall of study information are diagnostic misconception (research participants consider research as part of medical diagnosis), and information overload and situational vulnerability (consent at a time of physical and emotional distress). There is a need for improved practices to support research participants’ understanding of consent information in genetics studies including designing the consent process in ways that minimize psychological distress and diagnostic/therapeutic misconception.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"16 1","pages":"265 - 280"},"PeriodicalIF":1.7,"publicationDate":"2022-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82741137","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 : 2022-04-30DOI: 10.1177/17470161221094134
Kelsey Shanks, J. Paulson
As the prevalence of conflict and fragility continue to rise around the world, research is increasingly heralded as a solution. However, current ethical guidelines for working in areas suffering from institutional and social fragility, insecurity or violent conflict have been heavily critiqued as highly abstract; focussed only on data collection; detached from the realities of academia in the Global South; and potentially extractive. This article seeks to respond to that assessment by spotlighting some of the most prevalent challenges researchers face in the pursuit of ethical working practices. It explores the material and epistemic injustices that often shape and underpin research structures and relationships in these contexts. The paper draws on the authors’ experiences of research in conflict-affected and fragile contexts over the last fifteen years and on workshop discussions with researchers based in fragile and conflict-affected contexts conducted in Amman, Bogotá and Dhaka in 2019-2020. The paper works from the premise that achieving ethical research in fragile spaces is not dependent solely on activity at the site of research, but also on decisions made across the entire ecosystem of a research project. It therefore interrogates the full research landscape, from funding models, to research design (including research topics, partnerships, methods, participant selection, and researcher positionality), to dissemination plans and ethical gatekeeping. The paper critically reflects on inequities in the processes of knowledge production about conflict and fragility and the key ethical challenges that researchers encounter. It highlights the need for further guidance, support and accountability to ensure ethical research practices.
{"title":"Ethical research landscapes in fragile and conflict-affected contexts: understanding the challenges","authors":"Kelsey Shanks, J. Paulson","doi":"10.1177/17470161221094134","DOIUrl":"https://doi.org/10.1177/17470161221094134","url":null,"abstract":"As the prevalence of conflict and fragility continue to rise around the world, research is increasingly heralded as a solution. However, current ethical guidelines for working in areas suffering from institutional and social fragility, insecurity or violent conflict have been heavily critiqued as highly abstract; focussed only on data collection; detached from the realities of academia in the Global South; and potentially extractive. This article seeks to respond to that assessment by spotlighting some of the most prevalent challenges researchers face in the pursuit of ethical working practices. It explores the material and epistemic injustices that often shape and underpin research structures and relationships in these contexts. The paper draws on the authors’ experiences of research in conflict-affected and fragile contexts over the last fifteen years and on workshop discussions with researchers based in fragile and conflict-affected contexts conducted in Amman, Bogotá and Dhaka in 2019-2020. The paper works from the premise that achieving ethical research in fragile spaces is not dependent solely on activity at the site of research, but also on decisions made across the entire ecosystem of a research project. It therefore interrogates the full research landscape, from funding models, to research design (including research topics, partnerships, methods, participant selection, and researcher positionality), to dissemination plans and ethical gatekeeping. The paper critically reflects on inequities in the processes of knowledge production about conflict and fragility and the key ethical challenges that researchers encounter. It highlights the need for further guidance, support and accountability to ensure ethical research practices.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"159 1","pages":"169 - 192"},"PeriodicalIF":1.7,"publicationDate":"2022-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79208242","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 : 2022-04-18DOI: 10.1177/17470161221093877
A. Pingitore, Ashley Mack, Justin Zhang, Eric G. Devine, Jackson Doerr, Caroline Denneen
Incidental findings in research with human participants may have implications for a person’s present health or future health outcomes. Current guidelines focus on methods for handling and reporting incidental findings from biological test data but incidental findings might also arise from non-biological tests. This article presents three examples in which the results from non-biological test data can be predictive of future disease and should be disclosed to research participants. It is intended to increase awareness and facilitate further discussion about the reporting of incidental findings from non-biological data.
{"title":"Reporting incidental findings from non-biological assessments in human subject research","authors":"A. Pingitore, Ashley Mack, Justin Zhang, Eric G. Devine, Jackson Doerr, Caroline Denneen","doi":"10.1177/17470161221093877","DOIUrl":"https://doi.org/10.1177/17470161221093877","url":null,"abstract":"Incidental findings in research with human participants may have implications for a person’s present health or future health outcomes. Current guidelines focus on methods for handling and reporting incidental findings from biological test data but incidental findings might also arise from non-biological tests. This article presents three examples in which the results from non-biological test data can be predictive of future disease and should be disclosed to research participants. It is intended to increase awareness and facilitate further discussion about the reporting of incidental findings from non-biological data.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":" 44","pages":"241 - 249"},"PeriodicalIF":1.7,"publicationDate":"2022-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72384907","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 : 2022-03-16DOI: 10.1177/17470161221087542
Jamie Mahoney, Kahina Le Louvier, S. Lawson, Diotima Bertel, E. Ambrosetti
The ubiquitous use of social platforms across the globe makes them attractive options for investigating social phenomena including migration. However, the use of social media data raises several crucial ethical issues around the areas of informed consent, anonymity and profiling of individuals, which are particularly sensitive when looking at a population such as migrants, which is often considered as ‘vulnerable’. In this paper, we discuss how the opportunities and challenges related to social media research in the context of migration impact on the development of large-scale scientific projects. Building on the EU-funded research project PERCEPTIONS, we explore the concrete challenges experienced in such projects regarding profiling, informed consent, bias, data sharing and ethical approval procedures, as well as the strategies used to mitigate them. We draw from lessons learned in this project to discuss implications and recommendations to researchers, funders and university ethics review panels. This paper contributes to the growing discussion on the ethical challenges associated with big social data research projects on migration by highlighting concrete aspects stakeholders should be looking for and questioning when involved in such large-scale scientific projects where collaboration, data sharing and transformation and practicalities are of importance.
{"title":"Ethical considerations in social media analytics in the context of migration: lessons learned from a Horizon 2020 project","authors":"Jamie Mahoney, Kahina Le Louvier, S. Lawson, Diotima Bertel, E. Ambrosetti","doi":"10.1177/17470161221087542","DOIUrl":"https://doi.org/10.1177/17470161221087542","url":null,"abstract":"The ubiquitous use of social platforms across the globe makes them attractive options for investigating social phenomena including migration. However, the use of social media data raises several crucial ethical issues around the areas of informed consent, anonymity and profiling of individuals, which are particularly sensitive when looking at a population such as migrants, which is often considered as ‘vulnerable’. In this paper, we discuss how the opportunities and challenges related to social media research in the context of migration impact on the development of large-scale scientific projects. Building on the EU-funded research project PERCEPTIONS, we explore the concrete challenges experienced in such projects regarding profiling, informed consent, bias, data sharing and ethical approval procedures, as well as the strategies used to mitigate them. We draw from lessons learned in this project to discuss implications and recommendations to researchers, funders and university ethics review panels. This paper contributes to the growing discussion on the ethical challenges associated with big social data research projects on migration by highlighting concrete aspects stakeholders should be looking for and questioning when involved in such large-scale scientific projects where collaboration, data sharing and transformation and practicalities are of importance.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"59 1","pages":"226 - 240"},"PeriodicalIF":1.7,"publicationDate":"2022-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76348333","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 : 2022-03-16DOI: 10.1177/17470161221085857
Natalie Schembri, Alma Jahić Jašić
Interview-based research in multilingual situations can present researchers with specific ethical challenges relating to language-based power play, data handling and presentation. Studies indicate favouring the L1 (first language) as an interviewing language may produce better quality data, but external pressures can favour English as the dominant research language. This article examines researcher perceptions and experiences of the ethical consequences of language choice and the practical issues involved. Interviews were conducted with five European researchers working on an interview-based project with experiences of diverse interviewing scenarios. The four moral principles of respect for autonomy, justice, beneficence and non-maleficence were used as a framework for analysis. The analysis revealed a nuanced picture of ethical issues in both L1- and English-oriented scenarios. This included potential misrepresentation and deculturalisation of the data in the former, and language-based power asymmetries in the latter. The findings highlight the importance of documenting ethics-related methodological details of language use, and advocates publication practices favouring the inclusion and foregrounding of L1 data.
{"title":"Ethical issues in multilingual research situations: a focus on interview-based research","authors":"Natalie Schembri, Alma Jahić Jašić","doi":"10.1177/17470161221085857","DOIUrl":"https://doi.org/10.1177/17470161221085857","url":null,"abstract":"Interview-based research in multilingual situations can present researchers with specific ethical challenges relating to language-based power play, data handling and presentation. Studies indicate favouring the L1 (first language) as an interviewing language may produce better quality data, but external pressures can favour English as the dominant research language. This article examines researcher perceptions and experiences of the ethical consequences of language choice and the practical issues involved. Interviews were conducted with five European researchers working on an interview-based project with experiences of diverse interviewing scenarios. The four moral principles of respect for autonomy, justice, beneficence and non-maleficence were used as a framework for analysis. The analysis revealed a nuanced picture of ethical issues in both L1- and English-oriented scenarios. This included potential misrepresentation and deculturalisation of the data in the former, and language-based power asymmetries in the latter. The findings highlight the importance of documenting ethics-related methodological details of language use, and advocates publication practices favouring the inclusion and foregrounding of L1 data.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"29 1","pages":"210 - 225"},"PeriodicalIF":1.7,"publicationDate":"2022-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89175929","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 : 2022-02-03DOI: 10.1177/17470161221076948
S. Mason, Lenandlar Singh
Twitter is an increasingly common source of rich, personalized qualitative data, as millions of people daily share their thoughts on myriad topics. However, questions remain unclear concerning if and how to quote publicly available social media data ethically. In this study, focusing on 136 education manuscripts quoting 2667 Tweets, we look to investigate the ways in which Tweets are quoted, the ethical discussions forwarded and actions taken, and the extent to which quoted Tweets are “discoverable.” A concerning result is that in almost all manuscripts, and for around half of all quoted Tweets, the original author could be identified. Drawing on our findings we share some ethical dilemmas, including those that arise from an apparent lack of understanding of the technical aspects of the platform, and offer suggestions for promoting ethically-informed practice.
{"title":"Reporting and discoverability of “Tweets” quoted in published scholarship: current practice and ethical implications","authors":"S. Mason, Lenandlar Singh","doi":"10.1177/17470161221076948","DOIUrl":"https://doi.org/10.1177/17470161221076948","url":null,"abstract":"Twitter is an increasingly common source of rich, personalized qualitative data, as millions of people daily share their thoughts on myriad topics. However, questions remain unclear concerning if and how to quote publicly available social media data ethically. In this study, focusing on 136 education manuscripts quoting 2667 Tweets, we look to investigate the ways in which Tweets are quoted, the ethical discussions forwarded and actions taken, and the extent to which quoted Tweets are “discoverable.” A concerning result is that in almost all manuscripts, and for around half of all quoted Tweets, the original author could be identified. Drawing on our findings we share some ethical dilemmas, including those that arise from an apparent lack of understanding of the technical aspects of the platform, and offer suggestions for promoting ethically-informed practice.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"41 1","pages":"93 - 113"},"PeriodicalIF":1.7,"publicationDate":"2022-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88800044","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 : 2022-01-13DOI: 10.1177/17470161211068745
Mina Mehregan
Citation is an essential practice in scientific publishing. However, it is mandatory that citing the sources in a scientific work is performed in a proper manner. Manipulating citations in research articles is one form of academic research misconduct that violates publication ethics. Citation manipulation simply occurs for the purpose of increasing the number of citations of a researcher or a journal. Unfortunately, there has been a growing trend for this type of misconduct recently and this has not received much attention from the science community. The most effective solution to prevent the growth of such unethical practices is for reputable journals to impose stricter rules on reference evaluation criteria in order to emphasize on the appropriateness of the citations.
{"title":"Scientific journals must be alert to potential manipulation in citations and referencing","authors":"Mina Mehregan","doi":"10.1177/17470161211068745","DOIUrl":"https://doi.org/10.1177/17470161211068745","url":null,"abstract":"Citation is an essential practice in scientific publishing. However, it is mandatory that citing the sources in a scientific work is performed in a proper manner. Manipulating citations in research articles is one form of academic research misconduct that violates publication ethics. Citation manipulation simply occurs for the purpose of increasing the number of citations of a researcher or a journal. Unfortunately, there has been a growing trend for this type of misconduct recently and this has not received much attention from the science community. The most effective solution to prevent the growth of such unethical practices is for reputable journals to impose stricter rules on reference evaluation criteria in order to emphasize on the appropriateness of the citations.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"79 1","pages":"163 - 168"},"PeriodicalIF":1.7,"publicationDate":"2022-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80141938","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 : 2022-01-01DOI: 10.1177/17470161211054021
Laurel E Meyer, Lauren Porter, Meghan E Reilly, Caroline Johnson, Salman Safir, Shelly F Greenfield, Benjamin C Silverman, James I Hudson, Kristin N Javaras
Automated, wearable cameras can benefit health-related research by capturing accurate and objective information about individuals' daily experiences. However, wearable cameras present unique privacy- and confidentiality-related risks due to the possibility of the images capturing identifying or sensitive information from participants and third parties. Although best practice guidelines for ethical research with wearable cameras have been published, limited information exists on the risks of studies using wearable cameras. The aim of this literature review was to survey risks related to using wearable cameras, and precautions taken to reduce those risks, as reported in empirical research. Forty-five publications, comprising 36 independent studies, were reviewed, and findings revealed that participants' primary concerns with using wearable cameras included physical inconvenience and discomfort in certain situations (e.g., public settings). None of the studies reviewed reported any serious adverse events. Although it is possible that reported findings do not include all risks experienced by participants in research with wearable cameras, our findings suggest a low level of risk to participants. However, it is important that investigators adopt recommended precautions, which can promote autonomy and reduce risks, including participant discomfort.
{"title":"Using Wearable Cameras to Investigate Health-Related Daily Life Experiences: A Literature Review of Precautions and Risks in Empirical Studies.","authors":"Laurel E Meyer, Lauren Porter, Meghan E Reilly, Caroline Johnson, Salman Safir, Shelly F Greenfield, Benjamin C Silverman, James I Hudson, Kristin N Javaras","doi":"10.1177/17470161211054021","DOIUrl":"https://doi.org/10.1177/17470161211054021","url":null,"abstract":"<p><p>Automated, wearable cameras can benefit health-related research by capturing accurate and objective information about individuals' daily experiences. However, wearable cameras present unique privacy- and confidentiality-related risks due to the possibility of the images capturing identifying or sensitive information from participants and third parties. Although best practice guidelines for ethical research with wearable cameras have been published, limited information exists on the risks of studies using wearable cameras. The aim of this literature review was to survey risks related to using wearable cameras, and precautions taken to reduce those risks, as reported in empirical research. Forty-five publications, comprising 36 independent studies, were reviewed, and findings revealed that participants' primary concerns with using wearable cameras included physical inconvenience and discomfort in certain situations (e.g., public settings). None of the studies reviewed reported any serious adverse events. Although it is possible that reported findings do not include all risks experienced by participants in research with wearable cameras, our findings suggest a low level of risk to participants. However, it is important that investigators adopt recommended precautions, which can promote autonomy and reduce risks, including participant discomfort.</p>","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"18 1","pages":"64-83"},"PeriodicalIF":1.7,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9307222/pdf/nihms-1761547.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10464412","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 : 2021-12-16DOI: 10.1177/17470161211066445
S. Dalton-Brown
Learning about research ethics and research integrity is greatly facilitated by case studies, which illuminate, ground and personalise abstract questions. This paper argues that fiction can provide similar learning experiences, incarnating ethical dilemmas through a medium that is highly accessible yet sophisticated in its depictions of how researchers behave. Examples of fictional illustrations are given to illustrate various themes such as animal experimentation, exploitation of the vulnerable, researcher bias and research fraud.
{"title":"Personalising the dilemma: research ethics in fiction","authors":"S. Dalton-Brown","doi":"10.1177/17470161211066445","DOIUrl":"https://doi.org/10.1177/17470161211066445","url":null,"abstract":"Learning about research ethics and research integrity is greatly facilitated by case studies, which illuminate, ground and personalise abstract questions. This paper argues that fiction can provide similar learning experiences, incarnating ethical dilemmas through a medium that is highly accessible yet sophisticated in its depictions of how researchers behave. Examples of fictional illustrations are given to illustrate various themes such as animal experimentation, exploitation of the vulnerable, researcher bias and research fraud.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"22 1","pages":"114 - 125"},"PeriodicalIF":1.7,"publicationDate":"2021-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79943234","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 : 2021-12-15DOI: 10.1177/17470161211066159
Y. Kislovskiy, C. Chappell, Emily Flaherty, M. Hamm, F. de Abril Cameron, E. Krans, Judy C. Chang
Limited research has been done among pregnant people participating in investigational drug trials. To enhance the ethical understanding of pregnant people’s perspectives on research participation, we sought to describe motives and risk perceptions of participants in a phase 1 trial of ledipasvir/sofosbuvir (LDV/SOF) treatment for chronic Hepatitis C virus (HCV) during pregnancy. Pregnant people with chronic HCV infection enrolled in an open-label, phase 1 study of LDV/SOF participated in semi-structured, in-depth interviews to explore their reasons for participation and experiences within the study. Pregnant people took 12 weeks of LDV/SOF and were interviewed at enrollment and at the end of study. We recorded the interviews, transcribed them verbatim, coded them using NVivo software, and performed inductive thematic analysis. Nine women completed the study yielding 18 interview transcripts. We identified two themes regarding motives and one regarding risk perception. Motives—(1) Women conceptualized study participation as part of the caregiving role they associate with motherhood; participating was viewed as an act of caregiving for their infants, their families, themselves, and other pregnant women with chronic HCV. (2) Women also noted that they faced multiple barriers to treatment prior to pregnancy that created a desire to receive therapy through trial participation. Risk perception—(3) Women acknowledged personal and fetal risk associated with participation. Acceptance of risk was influenced by women’s concepts of motherhood, preexisting knowledge of HCV and medical research, family members, intimate partners, or by the study design. Women enrolled in a phase 1 trial for chronic HCV therapy during pregnancy acknowledged risks of participation and were motivated by hopes for fetal and personal benefit and by lack of prenatal access to treatment. Ethical inclusion of pregnant people in research should acknowledge structural factors that contribute to vulnerability and data deficiencies for treatment in pregnancy.
{"title":"Motives and risk perceptions of participants in a phase 1 trial for Hepatitis C Virus investigational therapy in pregnancy","authors":"Y. Kislovskiy, C. Chappell, Emily Flaherty, M. Hamm, F. de Abril Cameron, E. Krans, Judy C. Chang","doi":"10.1177/17470161211066159","DOIUrl":"https://doi.org/10.1177/17470161211066159","url":null,"abstract":"Limited research has been done among pregnant people participating in investigational drug trials. To enhance the ethical understanding of pregnant people’s perspectives on research participation, we sought to describe motives and risk perceptions of participants in a phase 1 trial of ledipasvir/sofosbuvir (LDV/SOF) treatment for chronic Hepatitis C virus (HCV) during pregnancy. Pregnant people with chronic HCV infection enrolled in an open-label, phase 1 study of LDV/SOF participated in semi-structured, in-depth interviews to explore their reasons for participation and experiences within the study. Pregnant people took 12 weeks of LDV/SOF and were interviewed at enrollment and at the end of study. We recorded the interviews, transcribed them verbatim, coded them using NVivo software, and performed inductive thematic analysis. Nine women completed the study yielding 18 interview transcripts. We identified two themes regarding motives and one regarding risk perception. Motives—(1) Women conceptualized study participation as part of the caregiving role they associate with motherhood; participating was viewed as an act of caregiving for their infants, their families, themselves, and other pregnant women with chronic HCV. (2) Women also noted that they faced multiple barriers to treatment prior to pregnancy that created a desire to receive therapy through trial participation. Risk perception—(3) Women acknowledged personal and fetal risk associated with participation. Acceptance of risk was influenced by women’s concepts of motherhood, preexisting knowledge of HCV and medical research, family members, intimate partners, or by the study design. Women enrolled in a phase 1 trial for chronic HCV therapy during pregnancy acknowledged risks of participation and were motivated by hopes for fetal and personal benefit and by lack of prenatal access to treatment. Ethical inclusion of pregnant people in research should acknowledge structural factors that contribute to vulnerability and data deficiencies for treatment in pregnancy.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"39 1","pages":"132 - 150"},"PeriodicalIF":1.7,"publicationDate":"2021-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86870016","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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