Pub Date : 2023-01-30DOI: 10.1177/17470161231152077
Inés Galende-Domínguez, O. Rivero-Lezcano
Progress in precision medicine is being achieved through the design of clinical trials that use genetic biomarkers to guide stratification of patients and assignation to treatment or control groups. Genetic analysis of biomarkers is, therefore, essential to complete their objectives, and this involves the study of biological samples from donor patients that have been recruited according to criteria previously established in the design of the clinical trial. Nevertheless, it is becoming very common that, in the solicitation of biological samples, purposes that are beyond the objectives of the stated therapeutic trial research are introduced, like the development of ill-explained exploratory studies or the use in unspecified future research. In the digital era, the sequencing of patients’ DNA needs to be considered as a serious security matter, not only for the patients, but also for their relatives. Genetic information may be easily stored, even forever, in digital files. This engenders a permanent risk of being stolen or misused in many ways. Furthermore, re-identification of sample donors is technically feasible through their genetic data. For these reasons, genetic analysis of samples collected in clinical trials should be restricted to the accomplishment of their main objectives or well justified goals.
{"title":"Ethical considerations about the collection of biological samples for genetic analysis in clinical trials","authors":"Inés Galende-Domínguez, O. Rivero-Lezcano","doi":"10.1177/17470161231152077","DOIUrl":"https://doi.org/10.1177/17470161231152077","url":null,"abstract":"Progress in precision medicine is being achieved through the design of clinical trials that use genetic biomarkers to guide stratification of patients and assignation to treatment or control groups. Genetic analysis of biomarkers is, therefore, essential to complete their objectives, and this involves the study of biological samples from donor patients that have been recruited according to criteria previously established in the design of the clinical trial. Nevertheless, it is becoming very common that, in the solicitation of biological samples, purposes that are beyond the objectives of the stated therapeutic trial research are introduced, like the development of ill-explained exploratory studies or the use in unspecified future research. In the digital era, the sequencing of patients’ DNA needs to be considered as a serious security matter, not only for the patients, but also for their relatives. Genetic information may be easily stored, even forever, in digital files. This engenders a permanent risk of being stolen or misused in many ways. Furthermore, re-identification of sample donors is technically feasible through their genetic data. For these reasons, genetic analysis of samples collected in clinical trials should be restricted to the accomplishment of their main objectives or well justified goals.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"10 1","pages":"220 - 226"},"PeriodicalIF":1.7,"publicationDate":"2023-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87527667","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-12DOI: 10.1177/17470161221147801
E. Dove, C. Douglas
While ethical norms for conducting academic research in the United Kingdom are relatively clear, there is little empirical understanding of how university research ethics committees (RECs) themselves operate and whether they are seen to operate well. In this article, we offer insights from a project focused on the Scottish university context. We deployed a three-sided qualitative approach: (i) document analysis; (ii) interviews with REC members, administrators, and managers; and (iii) direct observation of REC meetings. We found that RECs have diverse operation and vary in terms of what members understand to be the remit of their REC and what should constitute the content of ethics review. Overall, though, most participants perceive university RECs as operating well. When asked what they consider to be areas for further improvement, most commented on: implementation of an online system; more experience with how to evaluate various kinds of research projects; best practice exchange and training opportunities; more accurate reflection of the REC role as part of the university’s workload allocation model; and greater recognition of the importance of research ethics governance in the university’s research environment, and, for the members themselves, their career advancement. Based on our findings and subsequent discussions during an end-of-project roundtable with stakeholders, we propose a model of collaboration that can address some of the identified areas that could benefit from further improvement. This model would facilitate a heightened awareness of the importance of supporting REC members in their own effort in assisting students and staff alike in undertaking as ethically robust research as possible.
{"title":"Ethics governance in Scottish universities: how can we do better? A qualitative study","authors":"E. Dove, C. Douglas","doi":"10.1177/17470161221147801","DOIUrl":"https://doi.org/10.1177/17470161221147801","url":null,"abstract":"While ethical norms for conducting academic research in the United Kingdom are relatively clear, there is little empirical understanding of how university research ethics committees (RECs) themselves operate and whether they are seen to operate well. In this article, we offer insights from a project focused on the Scottish university context. We deployed a three-sided qualitative approach: (i) document analysis; (ii) interviews with REC members, administrators, and managers; and (iii) direct observation of REC meetings. We found that RECs have diverse operation and vary in terms of what members understand to be the remit of their REC and what should constitute the content of ethics review. Overall, though, most participants perceive university RECs as operating well. When asked what they consider to be areas for further improvement, most commented on: implementation of an online system; more experience with how to evaluate various kinds of research projects; best practice exchange and training opportunities; more accurate reflection of the REC role as part of the university’s workload allocation model; and greater recognition of the importance of research ethics governance in the university’s research environment, and, for the members themselves, their career advancement. Based on our findings and subsequent discussions during an end-of-project roundtable with stakeholders, we propose a model of collaboration that can address some of the identified areas that could benefit from further improvement. This model would facilitate a heightened awareness of the importance of supporting REC members in their own effort in assisting students and staff alike in undertaking as ethically robust research as possible.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"40 1","pages":"166 - 198"},"PeriodicalIF":1.7,"publicationDate":"2023-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84745680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01Epub Date: 2022-10-30DOI: 10.1177/17470161221131497
Lauren R Sankary, Megan E Zelinsky, Paul J Ford, Eric C Blackstone, Robert J Fox
The ethical recruitment of participants with neurological disorders in clinical research requires obtaining initial and ongoing informed consent. The purpose of this study is to characterize barriers faced by research personnel in obtaining informed consent from research participants with neurological disorders and to identify strategies applied by researchers to overcome those barriers. This study was designed as a web-based survey of US researchers with an optional follow-up interview. A subset of participants who completed the survey were selected using a stratified purposeful sampling strategy and invited to participate in an in-depth qualitative interview by phone or video conference. Data were analyzed using a mixed methods approach, including content analysis of survey responses and thematic analysis of interview responses. Over 1 year, 113 survey responses were received from US research personnel directly involved in obtaining informed consent from participants in neurological research. Frequently identified barriers to informed consent included: cognitive and communication impairments (e.g. aphasia), unrealistic expectations of research participants, mistrust of medical research, time constraints, literacy barriers, lack of available social support, and practical or resource-related constraints. Strategies to enhance informed consent included: involving close others to support participant understanding of study-related information, collaborating with more experienced research personnel to facilitate training in obtaining informed consent, encouraging participants to review consent forms in advance of consent discussions, and using printed materials and visual references. Beyond conveying study-related information, researchers included in this study endorsed ethical responsibilities to support deliberation necessary to informed consent in the context of misconceptions about research, unrealistic expectations, limited understanding, mistrust, and/or pressure from close others. Findings highlight the importance of training researchers involved in obtaining informed consent in neurological research to address disease-specific challenges and to support the decision-making processes of potential research participants and their close others.
{"title":"Overcoming barriers to informed consent in neurological research: Perspectives from a national survey.","authors":"Lauren R Sankary, Megan E Zelinsky, Paul J Ford, Eric C Blackstone, Robert J Fox","doi":"10.1177/17470161221131497","DOIUrl":"10.1177/17470161221131497","url":null,"abstract":"<p><p>The ethical recruitment of participants with neurological disorders in clinical research requires obtaining initial and ongoing informed consent. The purpose of this study is to characterize barriers faced by research personnel in obtaining informed consent from research participants with neurological disorders and to identify strategies applied by researchers to overcome those barriers. This study was designed as a web-based survey of US researchers with an optional follow-up interview. A subset of participants who completed the survey were selected using a stratified purposeful sampling strategy and invited to participate in an in-depth qualitative interview by phone or video conference. Data were analyzed using a mixed methods approach, including content analysis of survey responses and thematic analysis of interview responses. Over 1 year, 113 survey responses were received from US research personnel directly involved in obtaining informed consent from participants in neurological research. Frequently identified barriers to informed consent included: cognitive and communication impairments (e.g. aphasia), unrealistic expectations of research participants, mistrust of medical research, time constraints, literacy barriers, lack of available social support, and practical or resource-related constraints. Strategies to enhance informed consent included: involving close others to support participant understanding of study-related information, collaborating with more experienced research personnel to facilitate training in obtaining informed consent, encouraging participants to review consent forms in advance of consent discussions, and using printed materials and visual references. Beyond conveying study-related information, researchers included in this study endorsed ethical responsibilities to support deliberation necessary to informed consent in the context of misconceptions about research, unrealistic expectations, limited understanding, mistrust, and/or pressure from close others. Findings highlight the importance of training researchers involved in obtaining informed consent in neurological research to address disease-specific challenges and to support the decision-making processes of potential research participants and their close others.</p>","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"19 1","pages":"42-61"},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10609656/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71414490","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-12-25DOI: 10.1177/17470161221147440
Naomi Holbeach, Ian Freckelton Ao Qc, Bency Mol
As the burden of misconduct in medical research is increasingly recognised, questions have been raised about how best to address this problem. Whilst there are existing mechanisms for the investigation and management of misconduct in medical literature, they are inadequate to deal with the magnitude of the problem. Journal editors and publishers play an essential role in protecting the veracity of the medical literature. Whilst ethical guidance for journal editors and publishers is important, it is not as readily enforceable as legal obligations might be. This article questions the legal obligations that might exist for journal editors and publishing companies with respect to ensuring the veracity of the published literature. Ultimately, there is no enforceable legal obligation in Australia, the United Kingdom, or the United States. In light of this, more robust mechanisms are needed to deliver greater confidence and transparency in the investigative process, the management of concerns or findings of misconduct and the need to cleanse the literature. We show that the law disincentivises journals and publishers from ensuring truth in their publications. There are harmful consequences for medical care and public confidence in the medical profession and health care system when the foundations of medical science are questionable.
{"title":"Journal editors and publishers’ legal obligations with respect to medical research misconduct","authors":"Naomi Holbeach, Ian Freckelton Ao Qc, Bency Mol","doi":"10.1177/17470161221147440","DOIUrl":"https://doi.org/10.1177/17470161221147440","url":null,"abstract":"As the burden of misconduct in medical research is increasingly recognised, questions have been raised about how best to address this problem. Whilst there are existing mechanisms for the investigation and management of misconduct in medical literature, they are inadequate to deal with the magnitude of the problem. Journal editors and publishers play an essential role in protecting the veracity of the medical literature. Whilst ethical guidance for journal editors and publishers is important, it is not as readily enforceable as legal obligations might be. This article questions the legal obligations that might exist for journal editors and publishing companies with respect to ensuring the veracity of the published literature. Ultimately, there is no enforceable legal obligation in Australia, the United Kingdom, or the United States. In light of this, more robust mechanisms are needed to deliver greater confidence and transparency in the investigative process, the management of concerns or findings of misconduct and the need to cleanse the literature. We show that the law disincentivises journals and publishers from ensuring truth in their publications. There are harmful consequences for medical care and public confidence in the medical profession and health care system when the foundations of medical science are questionable.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"37 1","pages":"107 - 120"},"PeriodicalIF":1.7,"publicationDate":"2022-12-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79087945","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 : 2022-12-25DOI: 10.1177/17470161221147202
Jessica Carniel, A. Hickey, Kim Southey, Annette Brömdal, Lynda Crowley-Cyr, Douglas C. Eacersall, William F Farmer, R. Gehrmann, T. Machin, Yosheen Pillay
Ethics review processes are frequently perceived as extending from codes and protocols rooted in biomedical disciplines. As a result, many researchers in the humanities and social sciences (HASS) find these processes to be misaligned, if not outrightly obstructive to their research. This leads some scholars to advocate against HASS participation in institutional review processes as they currently stand, or in their entirety. While ethics review processes can present a challenge to HASS researchers, these are not insurmountable and, in fact, present opportunities for ethics review boards (ERBs) to mediate their practices to better attend to the concerns of the HASS disciplines. By highlighting the potential value of the ethics review process in recognising the nuances and specificity across different forms of research, this article explores the generative possibilities of greater collaboration between HASS researchers and ERBs. Remaining cognisant of the epistemic and methodological differences that mark different disciplinary formations in turn will benefit the ethical conduct of all researchers.
{"title":"The ethics review and the humanities and social sciences: disciplinary distinctions in ethics review processes","authors":"Jessica Carniel, A. Hickey, Kim Southey, Annette Brömdal, Lynda Crowley-Cyr, Douglas C. Eacersall, William F Farmer, R. Gehrmann, T. Machin, Yosheen Pillay","doi":"10.1177/17470161221147202","DOIUrl":"https://doi.org/10.1177/17470161221147202","url":null,"abstract":"Ethics review processes are frequently perceived as extending from codes and protocols rooted in biomedical disciplines. As a result, many researchers in the humanities and social sciences (HASS) find these processes to be misaligned, if not outrightly obstructive to their research. This leads some scholars to advocate against HASS participation in institutional review processes as they currently stand, or in their entirety. While ethics review processes can present a challenge to HASS researchers, these are not insurmountable and, in fact, present opportunities for ethics review boards (ERBs) to mediate their practices to better attend to the concerns of the HASS disciplines. By highlighting the potential value of the ethics review process in recognising the nuances and specificity across different forms of research, this article explores the generative possibilities of greater collaboration between HASS researchers and ERBs. Remaining cognisant of the epistemic and methodological differences that mark different disciplinary formations in turn will benefit the ethical conduct of all researchers.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"22 1","pages":"139 - 156"},"PeriodicalIF":1.7,"publicationDate":"2022-12-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83116617","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 : 2022-11-30DOI: 10.1177/17470161221141275
Michelle Lam, Akech Mayuom
This article describes a project involving 13 community focus groups on the topic of anti-racism and belonging where the researchers concluded each group with a robust discussion about how the group would prefer to receive the findings from the project. Analysis of this data, existing literature, and the practical experiences of the researchers revealed that while there are multiple “bridges” researchers can take to connect their research with community-level users, and although it is desirable to offer tailored approaches for specific audiences, there are significant barriers and challenges for truly effective engagement. By describing the various factors that determined which bridges were taken, we hope to help other community-based researchers imagine new ways of mobilizing knowledge, consider promising practices to guide the connection of knowledge to the community and shine a light on the very real constraints of time, budget, personnel, and university system considerations that impact knowledge mobilization decisions.
{"title":"Promising practices and constraining factors in mobilizing community-engaged research","authors":"Michelle Lam, Akech Mayuom","doi":"10.1177/17470161221141275","DOIUrl":"https://doi.org/10.1177/17470161221141275","url":null,"abstract":"This article describes a project involving 13 community focus groups on the topic of anti-racism and belonging where the researchers concluded each group with a robust discussion about how the group would prefer to receive the findings from the project. Analysis of this data, existing literature, and the practical experiences of the researchers revealed that while there are multiple “bridges” researchers can take to connect their research with community-level users, and although it is desirable to offer tailored approaches for specific audiences, there are significant barriers and challenges for truly effective engagement. By describing the various factors that determined which bridges were taken, we hope to help other community-based researchers imagine new ways of mobilizing knowledge, consider promising practices to guide the connection of knowledge to the community and shine a light on the very real constraints of time, budget, personnel, and university system considerations that impact knowledge mobilization decisions.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"39 1","pages":"199 - 219"},"PeriodicalIF":1.7,"publicationDate":"2022-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76839692","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 : 2022-11-29DOI: 10.1177/17470161221141011
N. Brown
The role of research ethics committees, and research ethics issues more broadly are often not viewed in the context of the development of scientific methods and the academic community. This topic piece seeks to redress this gap. I begin with a brief outline of the changes we experience within the social sciences before exploring in more detail their impact on research ethics and the practices of research ethics committees. I conclude with recommendations for how the existing research ethics processes may be made more future-proof.
{"title":"Research ethics in a changing social sciences landscape","authors":"N. Brown","doi":"10.1177/17470161221141011","DOIUrl":"https://doi.org/10.1177/17470161221141011","url":null,"abstract":"The role of research ethics committees, and research ethics issues more broadly are often not viewed in the context of the development of scientific methods and the academic community. This topic piece seeks to redress this gap. I begin with a brief outline of the changes we experience within the social sciences before exploring in more detail their impact on research ethics and the practices of research ethics committees. I conclude with recommendations for how the existing research ethics processes may be made more future-proof.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"16 1","pages":"157 - 165"},"PeriodicalIF":1.7,"publicationDate":"2022-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73455630","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 : 2022-11-21DOI: 10.1177/17470161221135882
L. Wood, S. Kahts-Kramer
Many reviewers of applications for ethical approval of research at universities struggle to understand what is considered ethical conduct in community-based research (CBR). Their difficulty in understanding CBR and the ethics embedded within it is, in part, due to the exclusion of CBR from researchers’ mandatory research ethics training. After all, CBR challenges both pedagogically and epistemologically the dominant paradigm/s whose worldviews, values and inherent structures of power help sustain the status quo within academic institutions at large. Consequently, CBR ethics applications are often prolonged due to back-and-forth rebuttals. In this article, we analyse our experiences in a South African institution of the ethics approval process for our various CBR projects over the past couple of years. Data for this purpose was generated from analysis of our reflexive dialogues as well as our responses to feedback from the ethics review boards. To help support the trustworthiness of the study, we invited critical friends to a workshop to engage with our findings. We identified three main themes all associated with how the values, worldviews and approaches of CBR differ from those of the dominant research paradigm/s, that impeded on the progress of our applications through the ethics approval process. On the basis of our analysis, we offer guidelines and a participatory research checklist for university ethics review panels to help inform their evaluation of applications concerning CBR. While universities now actively promote community engagement initiatives, and since CBR is an efficacious approach to that end, we advocate for inclusion of CBR ethics in universities’ mandatory ethics training, to help address ethical concerns that impede CBR research.
{"title":"‘But how will you ensure the objectivity of the researcher?’ Guidelines to address possible misconceptions about the ethical imperatives of community-based research","authors":"L. Wood, S. Kahts-Kramer","doi":"10.1177/17470161221135882","DOIUrl":"https://doi.org/10.1177/17470161221135882","url":null,"abstract":"Many reviewers of applications for ethical approval of research at universities struggle to understand what is considered ethical conduct in community-based research (CBR). Their difficulty in understanding CBR and the ethics embedded within it is, in part, due to the exclusion of CBR from researchers’ mandatory research ethics training. After all, CBR challenges both pedagogically and epistemologically the dominant paradigm/s whose worldviews, values and inherent structures of power help sustain the status quo within academic institutions at large. Consequently, CBR ethics applications are often prolonged due to back-and-forth rebuttals. In this article, we analyse our experiences in a South African institution of the ethics approval process for our various CBR projects over the past couple of years. Data for this purpose was generated from analysis of our reflexive dialogues as well as our responses to feedback from the ethics review boards. To help support the trustworthiness of the study, we invited critical friends to a workshop to engage with our findings. We identified three main themes all associated with how the values, worldviews and approaches of CBR differ from those of the dominant research paradigm/s, that impeded on the progress of our applications through the ethics approval process. On the basis of our analysis, we offer guidelines and a participatory research checklist for university ethics review panels to help inform their evaluation of applications concerning CBR. While universities now actively promote community engagement initiatives, and since CBR is an efficacious approach to that end, we advocate for inclusion of CBR ethics in universities’ mandatory ethics training, to help address ethical concerns that impede CBR research.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"4 1","pages":"1 - 17"},"PeriodicalIF":1.7,"publicationDate":"2022-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79532214","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 : 2022-11-18DOI: 10.1177/17470161221138028
E. Anderson, Elisa A. Hurley, Kimberley Serpico, Ann R. Johnson, Jessica Rowe, Megan Singleton, Barbara E. Bierer, Brooke Cholka, S. Chaudhari, Holly Fernandez Lynch
The primary purpose of Institutional Review Boards (IRBs) is to protect the rights and welfare of human research participants. Evaluation and measurement of how IRBs satisfy this purpose and other important goals are open questions that demand empirical research. Research on IRBs, and the Human Research Protection Programs (HRPPs) of which they are often a part, is necessary to inform evidence-based practices, policies, and approaches to quality improvement in human research protections. However, to date, HRPP and IRB engagement in empirical research about their own activities and performance has been limited. To promote engagement of HRPPs and IRBs in self-reflective research on HRPP and IRB quality and effectiveness, barriers to their participation need to be addressed. These include: extensive workloads, limited information technology systems, and few universally accepted or consistently measured metrics for HRPP/IRB quality and effectiveness. Additionally, institutional leaders may have concerns about confidentiality. Professional norms around the value of participating in this type of research are lacking. Lastly, obtaining external funding for research on IRBs and HRPPs is challenging. As a group of HRPP professionals and researchers actively involved in a research consortium focused on IRB quality and effectiveness, we identify potential levers for supporting and encouraging HRPP and IRB engagement in research on quality and effectiveness. We maintain that this research should be informed by the core principles of patient- and community-engaged research, in which members and key stakeholders of the community to be studied are included as key informants and members of the research team. This ensures that relevant questions are asked and that data are interpreted to produce meaningful recommendations. As such, we offer several ways to increase the participation of HRPP professionals in research as participants, as data sharers, and as investigators.
{"title":"Engaging key stakeholders to overcome barriers to studying the quality of research ethics oversight","authors":"E. Anderson, Elisa A. Hurley, Kimberley Serpico, Ann R. Johnson, Jessica Rowe, Megan Singleton, Barbara E. Bierer, Brooke Cholka, S. Chaudhari, Holly Fernandez Lynch","doi":"10.1177/17470161221138028","DOIUrl":"https://doi.org/10.1177/17470161221138028","url":null,"abstract":"The primary purpose of Institutional Review Boards (IRBs) is to protect the rights and welfare of human research participants. Evaluation and measurement of how IRBs satisfy this purpose and other important goals are open questions that demand empirical research. Research on IRBs, and the Human Research Protection Programs (HRPPs) of which they are often a part, is necessary to inform evidence-based practices, policies, and approaches to quality improvement in human research protections. However, to date, HRPP and IRB engagement in empirical research about their own activities and performance has been limited. To promote engagement of HRPPs and IRBs in self-reflective research on HRPP and IRB quality and effectiveness, barriers to their participation need to be addressed. These include: extensive workloads, limited information technology systems, and few universally accepted or consistently measured metrics for HRPP/IRB quality and effectiveness. Additionally, institutional leaders may have concerns about confidentiality. Professional norms around the value of participating in this type of research are lacking. Lastly, obtaining external funding for research on IRBs and HRPPs is challenging. As a group of HRPP professionals and researchers actively involved in a research consortium focused on IRB quality and effectiveness, we identify potential levers for supporting and encouraging HRPP and IRB engagement in research on quality and effectiveness. We maintain that this research should be informed by the core principles of patient- and community-engaged research, in which members and key stakeholders of the community to be studied are included as key informants and members of the research team. This ensures that relevant questions are asked and that data are interpreted to produce meaningful recommendations. As such, we offer several ways to increase the participation of HRPP professionals in research as participants, as data sharers, and as investigators.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"30 1","pages":"62 - 77"},"PeriodicalIF":1.7,"publicationDate":"2022-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81766747","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 : 2022-11-14DOI: 10.1177/17470161221131494
Lennart Kaplan, J. Kuhnt, Laura E Picot, C. Grasham
Across disciplines there is a large and increasing number of research projects that rely on data collection activities in low- and middle-income countries (LMICs). However, these are accompanied by an extensive range of ethical challenges. While the safeguarding of study participants is the primary aim of existing ethics guidelines, this paper argues that this “do no harm” principle should be extended to include research staff. This study is a comprehensive review of more than 80 existing ethics guidelines and protocols that reveals a lack of safeguarding research staff regarding the ethical challenges faced during data collection activities in LMICs. This is particularly the case when it comes to issues such as power imbalances, political risk, staff’s emotional wellbeing or dealing with feelings of guilt. Lead organizations are called upon to develop guiding principles that encompass the safeguarding of research staff, which are then to be adapted and translated into specific protocols and tools by institutions.
{"title":"Safeguarding research staff “in the field”: a blind spot in ethics guidelines","authors":"Lennart Kaplan, J. Kuhnt, Laura E Picot, C. Grasham","doi":"10.1177/17470161221131494","DOIUrl":"https://doi.org/10.1177/17470161221131494","url":null,"abstract":"Across disciplines there is a large and increasing number of research projects that rely on data collection activities in low- and middle-income countries (LMICs). However, these are accompanied by an extensive range of ethical challenges. While the safeguarding of study participants is the primary aim of existing ethics guidelines, this paper argues that this “do no harm” principle should be extended to include research staff. This study is a comprehensive review of more than 80 existing ethics guidelines and protocols that reveals a lack of safeguarding research staff regarding the ethical challenges faced during data collection activities in LMICs. This is particularly the case when it comes to issues such as power imbalances, political risk, staff’s emotional wellbeing or dealing with feelings of guilt. Lead organizations are called upon to develop guiding principles that encompass the safeguarding of research staff, which are then to be adapted and translated into specific protocols and tools by institutions.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"406 1","pages":"18 - 41"},"PeriodicalIF":1.7,"publicationDate":"2022-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75183261","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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