Pub Date : 2021-11-24DOI: 10.1177/17470161211058311
Owen M. Bradfield
In today’s online data-driven world, people constantly shed data and deposit digital footprints. When individuals access health services, governments and health providers collect and store large volumes of health information about people that can later be retrieved, linked and analysed for research purposes. This can lead to new discoveries in medicine and healthcare. In addition, when securely stored and de-identified, the privacy risks are minimal and manageable. In many jurisdictions, ethics committees routinely waive the requirement for researchers to obtain consent from data subjects before using and linking these datasets in an effort to balance respect for individuals with research efficiency. In this paper, I explore the ethical justification for using routinely collected health data for research without consent. I conclude that, not only is this morally justified but also that data subjects have a moral obligation to contribute their data to such research, which would obviate the need for ethics committees to consider consent waivers. In justifying this argument, I look to the duty of easy rescue, distributive justice and draw analogies with vaccination ethics.
{"title":"Waving away waivers: an obligation to contribute to ‘herd knowledge’ for data linkage research?","authors":"Owen M. Bradfield","doi":"10.1177/17470161211058311","DOIUrl":"https://doi.org/10.1177/17470161211058311","url":null,"abstract":"In today’s online data-driven world, people constantly shed data and deposit digital footprints. When individuals access health services, governments and health providers collect and store large volumes of health information about people that can later be retrieved, linked and analysed for research purposes. This can lead to new discoveries in medicine and healthcare. In addition, when securely stored and de-identified, the privacy risks are minimal and manageable. In many jurisdictions, ethics committees routinely waive the requirement for researchers to obtain consent from data subjects before using and linking these datasets in an effort to balance respect for individuals with research efficiency. In this paper, I explore the ethical justification for using routinely collected health data for research without consent. I conclude that, not only is this morally justified but also that data subjects have a moral obligation to contribute their data to such research, which would obviate the need for ethics committees to consider consent waivers. In justifying this argument, I look to the duty of easy rescue, distributive justice and draw analogies with vaccination ethics.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"12 1","pages":"151 - 162"},"PeriodicalIF":1.7,"publicationDate":"2021-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85583517","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 : 2021-11-18DOI: 10.1177/17470161211059993
J. Bélisle-Pipon, V. Couture, Marie-Christine Roy
Engaging citizens and patients in research has become a truism in many fields of health research. It is now seen as a laudable—if not compulsory—activity in research for yielding more impactful and meaningful citizen/patient outcomes and steering research in the right direction. Although this research approach is increasingly common and commendable, we recently encountered a major obstacle in obtaining an ethics certificate from an institutional review board (IRB) to conduct a study that places citizen/patient perspectives on equal footing with those of academic/policy experts. The obstacle was the interpretation of fairness in terms of compensation for research participation (i.e. honoraria). In terms of research ethics, this raised an important question: Should all types of participants be compensated equally, or should exceptions be made for citizen/patient participants? We argue that there are good reasons for exceptionalism and that clearer guidance on citizen/patient engagement in research should be embedded into research ethics doctrine.
{"title":"Equality and Equity in Compensating Patient Engagement in Research: A Plea for Exceptionalism","authors":"J. Bélisle-Pipon, V. Couture, Marie-Christine Roy","doi":"10.1177/17470161211059993","DOIUrl":"https://doi.org/10.1177/17470161211059993","url":null,"abstract":"Engaging citizens and patients in research has become a truism in many fields of health research. It is now seen as a laudable—if not compulsory—activity in research for yielding more impactful and meaningful citizen/patient outcomes and steering research in the right direction. Although this research approach is increasingly common and commendable, we recently encountered a major obstacle in obtaining an ethics certificate from an institutional review board (IRB) to conduct a study that places citizen/patient perspectives on equal footing with those of academic/policy experts. The obstacle was the interpretation of fairness in terms of compensation for research participation (i.e. honoraria). In terms of research ethics, this raised an important question: Should all types of participants be compensated equally, or should exceptions be made for citizen/patient participants? We argue that there are good reasons for exceptionalism and that clearer guidance on citizen/patient engagement in research should be embedded into research ethics doctrine.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"30 1","pages":"126 - 131"},"PeriodicalIF":1.7,"publicationDate":"2021-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78981481","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 : 2021-10-25DOI: 10.1177/17470161211053199
D. Zion, Richard Matthews
Aboriginal and Torres Strait Islander peoples in Australia, have historically experienced research as another means of colonialization and oppression. Although there are existing frameworks, guidelines and policies in place that respond to this history, the risk of exploitation and oppression arising from research still raises challenging ethical questions. Since the 1990s the National Health and Medical Research Council in Australia has developed specific sets of guidelines that govern research with these populations in an attempt to redress injustices of the past. The current guidelines: Ethical Conduct in Research with Aboriginal and Torres Strait Islander Peoples and Communities: Guidelines for Researchers and Stakeholders, 2018, emphasis six core values which are bound together by “spirit and integrity.” The values are reflected through respect for cultural inheritance, and genuine negotiation of partnerships between researchers, other stakeholders, and communities. We examine whether these guidelines can lead to research and research practices that redress some of the ongoing traumas of colonialization and racism. We draw upon Margaret Urban Walker’s formulation of restorative justice, based upon her “pragmatics of repair” which relies upon “voice, validation and vindication” and at its core, the restoration of relationships.
{"title":"Can research ethics codes be a conduit for justice? An examination of Aboriginal and Torres Strait Islander guidelines in Australia","authors":"D. Zion, Richard Matthews","doi":"10.1177/17470161211053199","DOIUrl":"https://doi.org/10.1177/17470161211053199","url":null,"abstract":"Aboriginal and Torres Strait Islander peoples in Australia, have historically experienced research as another means of colonialization and oppression. Although there are existing frameworks, guidelines and policies in place that respond to this history, the risk of exploitation and oppression arising from research still raises challenging ethical questions. Since the 1990s the National Health and Medical Research Council in Australia has developed specific sets of guidelines that govern research with these populations in an attempt to redress injustices of the past. The current guidelines: Ethical Conduct in Research with Aboriginal and Torres Strait Islander Peoples and Communities: Guidelines for Researchers and Stakeholders, 2018, emphasis six core values which are bound together by “spirit and integrity.” The values are reflected through respect for cultural inheritance, and genuine negotiation of partnerships between researchers, other stakeholders, and communities. We examine whether these guidelines can lead to research and research practices that redress some of the ongoing traumas of colonialization and racism. We draw upon Margaret Urban Walker’s formulation of restorative justice, based upon her “pragmatics of repair” which relies upon “voice, validation and vindication” and at its core, the restoration of relationships.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"39 1","pages":"51 - 63"},"PeriodicalIF":1.7,"publicationDate":"2021-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88905022","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 : 2021-10-12DOI: 10.1177/17470161211045526
S. Chua
Internet users’ comments in online spaces have attracted researchers’ attention in recent years. Although this data is typically publicly available, its use requires careful consideration so as to not cause harm to the users, while complying with the terms and conditions (Ts & Cs) of the online spaces. However, the Ts & Cs and researchers’ ethical considerations may sometimes be in conflict. I faced such a conflict when I conducted discourse analysis of online discussions that were sourced from a public online learning platform owned by a private company. In this article, I reflect on how I navigated the Ts & Cs and copyright law, taking users’ likely expectations into consideration when deciding whether to seek informed consent and anonymize content. I employed an ‘attribution with anonymization’ method to acknowledge users for their comments while safeguarding their confidentiality. Given the variety of online spaces and research methods, ethical decision-making must be a contextualized process that requires researchers to consider the nature of the online platform and the potential experience of the users, rather than simply following guidelines or Ts & Cs.
{"title":"Navigating conflict between research ethics and online platform terms and conditions: a reflective account","authors":"S. Chua","doi":"10.1177/17470161211045526","DOIUrl":"https://doi.org/10.1177/17470161211045526","url":null,"abstract":"Internet users’ comments in online spaces have attracted researchers’ attention in recent years. Although this data is typically publicly available, its use requires careful consideration so as to not cause harm to the users, while complying with the terms and conditions (Ts & Cs) of the online spaces. However, the Ts & Cs and researchers’ ethical considerations may sometimes be in conflict. I faced such a conflict when I conducted discourse analysis of online discussions that were sourced from a public online learning platform owned by a private company. In this article, I reflect on how I navigated the Ts & Cs and copyright law, taking users’ likely expectations into consideration when deciding whether to seek informed consent and anonymize content. I employed an ‘attribution with anonymization’ method to acknowledge users for their comments while safeguarding their confidentiality. Given the variety of online spaces and research methods, ethical decision-making must be a contextualized process that requires researchers to consider the nature of the online platform and the potential experience of the users, rather than simply following guidelines or Ts & Cs.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"33 1","pages":"39 - 50"},"PeriodicalIF":1.7,"publicationDate":"2021-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89853643","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 : 2021-10-10DOI: 10.1177/17470161211051230
A. Hoffman
The purpose of the traditional peer review process (TPR) is to provide a more constructive and scientifically rigorous critical review of scholarly research that builds scientific rigor and validity within diverse academic disciplines. Peer review has received criticism as the demand for publications in a variety of competitive journals has significantly increased while the number of individuals who are both willing and qualified to conduct thorough reviews is significantly declining. The purpose of this topic piece is to examine the overall efficacy of the peer review process and provide recommendations toward a more collaborative, transparent (i.e. “open”), and interdisciplinary communication process.
{"title":"A modest proposal to the peer review process: a collaborative and interdisciplinary approach in the assessment of scholarly communication","authors":"A. Hoffman","doi":"10.1177/17470161211051230","DOIUrl":"https://doi.org/10.1177/17470161211051230","url":null,"abstract":"The purpose of the traditional peer review process (TPR) is to provide a more constructive and scientifically rigorous critical review of scholarly research that builds scientific rigor and validity within diverse academic disciplines. Peer review has received criticism as the demand for publications in a variety of competitive journals has significantly increased while the number of individuals who are both willing and qualified to conduct thorough reviews is significantly declining. The purpose of this topic piece is to examine the overall efficacy of the peer review process and provide recommendations toward a more collaborative, transparent (i.e. “open”), and interdisciplinary communication process.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"1 1","pages":"84 - 91"},"PeriodicalIF":1.7,"publicationDate":"2021-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83468817","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 : 2021-10-01DOI: 10.1177/17470161211037906
{"title":"CORRIGENDUM to “Unconsented acknowledgments as a form of authorship abuse: What can be done about it?”","authors":"","doi":"10.1177/17470161211037906","DOIUrl":"https://doi.org/10.1177/17470161211037906","url":null,"abstract":"","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"40 1","pages":"522 - 522"},"PeriodicalIF":1.7,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87745534","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 : 2021-10-01DOI: 10.1177/17470161211037386
Neil Bilotta
As a white, Western-educated man, undertaking research in Kakuma refugee camp, Kenya, I encountered ethical dilemmas related to my privileged racial and gender status. These include power imbalances between researchers and refugees and conducting research in the face of human suffering. Through critical self-reflexivity, I analyze my own experiences to reveal the personal and professional vulnerabilities that researchers from high-income countries (HICs) may encounter when working in contexts where oppression and forced displacement are prominent. I conclude that researchers who work in contexts of forced migration must extend beyond the boundaries of procedural research ethics and include components of relational ethics. This involves close collaboration with refugee participants to develop more culturally relevant research ethics guidelines for refugee-specific populations.
{"title":"A critical self-reflexive account of a privileged researcher in a complicated setting: Kakuma refugee camp","authors":"Neil Bilotta","doi":"10.1177/17470161211037386","DOIUrl":"https://doi.org/10.1177/17470161211037386","url":null,"abstract":"As a white, Western-educated man, undertaking research in Kakuma refugee camp, Kenya, I encountered ethical dilemmas related to my privileged racial and gender status. These include power imbalances between researchers and refugees and conducting research in the face of human suffering. Through critical self-reflexivity, I analyze my own experiences to reveal the personal and professional vulnerabilities that researchers from high-income countries (HICs) may encounter when working in contexts where oppression and forced displacement are prominent. I conclude that researchers who work in contexts of forced migration must extend beyond the boundaries of procedural research ethics and include components of relational ethics. This involves close collaboration with refugee participants to develop more culturally relevant research ethics guidelines for refugee-specific populations.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"45 1","pages":"435 - 447"},"PeriodicalIF":1.7,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73590838","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 : 2021-10-01DOI: 10.1177/17470161211042658
Aidan C. Cairns, Caleb L. Linville, Tyler Garcia, B. Bridges, Scott Tanona, J. Herington, James T. Laverty
When scientists act unethically, their actions can cause harm to participants, undermine knowledge creation, and discredit the scientific community. Responsible Conduct of Research (RCR) training is one of the main ways institutions try to prevent scientists from acting unethically. However, this only addresses the problem if scientists value the training, and if the problem stems from ignorance. This study looks at what scientists think causes unethical behavior in science, with the hopes of improving RCR training by shaping it based on the views of the targeted audience (n = 14 scientists). Previous studies have surveyed scientists about what they believe causes unethical behavior using pre-defined response items. This study uses a qualitative research methodology to elicit scientists’ beliefs without predefining the range of responses. The data for this phenomenographic study were collected from interviews which presented ethical case studies and asked subjects how they would respond to those situations. Categories and subcategories were created to organize their reasonings. This work will inform the development of future methods for preventing unethical behavior in research.
{"title":"A phenomenographic study of scientists’ beliefs about the causes of scientists’ research misconduct","authors":"Aidan C. Cairns, Caleb L. Linville, Tyler Garcia, B. Bridges, Scott Tanona, J. Herington, James T. Laverty","doi":"10.1177/17470161211042658","DOIUrl":"https://doi.org/10.1177/17470161211042658","url":null,"abstract":"When scientists act unethically, their actions can cause harm to participants, undermine knowledge creation, and discredit the scientific community. Responsible Conduct of Research (RCR) training is one of the main ways institutions try to prevent scientists from acting unethically. However, this only addresses the problem if scientists value the training, and if the problem stems from ignorance. This study looks at what scientists think causes unethical behavior in science, with the hopes of improving RCR training by shaping it based on the views of the targeted audience (n = 14 scientists). Previous studies have surveyed scientists about what they believe causes unethical behavior using pre-defined response items. This study uses a qualitative research methodology to elicit scientists’ beliefs without predefining the range of responses. The data for this phenomenographic study were collected from interviews which presented ethical case studies and asked subjects how they would respond to those situations. Categories and subcategories were created to organize their reasonings. This work will inform the development of future methods for preventing unethical behavior in research.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"22 1","pages":"501 - 521"},"PeriodicalIF":1.7,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74448076","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 : 2021-09-22DOI: 10.1177/17470161211045557
Sara Bamdad, D. Finaughty, Sarah E. Johns
Are social science, cross-border research projects, where recruitment and data collection are carried out remotely (e.g. through social media and online platforms), required to follow similar ethical and data-sharing procedures as ‘on-the-ground’ studies that use traditional means of recruitment and participant engagement? This article reflects on our experience of dealing with this question when we (multi-national but UK based researchers) had to switch to online data collection due to the restrictions posed by the COVID-19 pandemic, such as the inability to travel or work in person with local communities and collaborators. Using social media platforms and online data collection when conducting research brings many advantages, such as being able to communicate remotely but directly with gatekeepers and collaborators, and in reaching potential participants on a global scale. However, neither the guidelines and advice for conducting ethically sound internet-based research, nor the academic literature focussed on building equitable research partnerships between the Global North and the Global South, offer much information regarding the ethical concerns, or address the grey areas, posed by this type of digital and distanced transnational research. In our experience, conducting research remotely made negotiations of access very challenging due to the politics of positionality between Global North and South researchers, lack of clarity on ethical processes and (mis)perceptions of gatekeepers who we could not meet in person. We hope the reflections on, and discussion of, our experience encourage deliberation on the present ethical challenges posed by online and social-media-disseminated data collection, particularly in cross-border circumstances.
{"title":"‘Grey areas’: ethical challenges posed by social media-enabled recruitment and online data collection in cross-border, social science research","authors":"Sara Bamdad, D. Finaughty, Sarah E. Johns","doi":"10.1177/17470161211045557","DOIUrl":"https://doi.org/10.1177/17470161211045557","url":null,"abstract":"Are social science, cross-border research projects, where recruitment and data collection are carried out remotely (e.g. through social media and online platforms), required to follow similar ethical and data-sharing procedures as ‘on-the-ground’ studies that use traditional means of recruitment and participant engagement? This article reflects on our experience of dealing with this question when we (multi-national but UK based researchers) had to switch to online data collection due to the restrictions posed by the COVID-19 pandemic, such as the inability to travel or work in person with local communities and collaborators. Using social media platforms and online data collection when conducting research brings many advantages, such as being able to communicate remotely but directly with gatekeepers and collaborators, and in reaching potential participants on a global scale. However, neither the guidelines and advice for conducting ethically sound internet-based research, nor the academic literature focussed on building equitable research partnerships between the Global North and the Global South, offer much information regarding the ethical concerns, or address the grey areas, posed by this type of digital and distanced transnational research. In our experience, conducting research remotely made negotiations of access very challenging due to the politics of positionality between Global North and South researchers, lack of clarity on ethical processes and (mis)perceptions of gatekeepers who we could not meet in person. We hope the reflections on, and discussion of, our experience encourage deliberation on the present ethical challenges posed by online and social-media-disseminated data collection, particularly in cross-border circumstances.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"2015 1","pages":"24 - 38"},"PeriodicalIF":1.7,"publicationDate":"2021-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73463810","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 : 2021-09-15DOI: 10.1177/17470161211043703
H. Davies
Consent is one necessary foundation for ethical research and it’s one of the research ethics committee’s major roles to ensure that the consent process meets acceptable standards. Although on Oxford ‘A’ REC (an NHS Research Ethics Committee based in the UK) we’ve been impressed by the thought and work put into this aspect of research ethics, we’ve continued to have concerns about the suitability and effectiveness of consent processes in supporting decision making, particularly for clinical trials. There’s poor understanding of what people want to help them decide; current processes don’t provide the best grounding for informed consent and there’s inadequate public involvement. We’ve also found a lack of proportionality with researchers failing to adapt consent procedures in proportion to the burdens and consequences of the study. As a result, people are often not best helped to make an informed choice when asked to join a research study. To address these concerns, we considered how we might improve this aspect of research ethics review. Recognising the central importance of the dialogue between the volunteer and researcher, we’ve drawn up a model or flowchart of what we deem good consent practice, proposing consent should be built around four simple steps: Step 1: Introducing the study and the choices: helping the potential participants get an overview of the proposal and introducing the key issues. Step 2: Explaining all the details of the study using the detailed Participant Information Sheet. Step 3: After a gap, if necessary, reviewing and checking understanding. Step 4: Reaching agreement and recording consent. These steps, we believe, could help all involved and this article lays out ways we might improve participant choice while complying with accepted principles and current regulations.
{"title":"Reshaping the review of consent so we might improve participant choice","authors":"H. Davies","doi":"10.1177/17470161211043703","DOIUrl":"https://doi.org/10.1177/17470161211043703","url":null,"abstract":"Consent is one necessary foundation for ethical research and it’s one of the research ethics committee’s major roles to ensure that the consent process meets acceptable standards. Although on Oxford ‘A’ REC (an NHS Research Ethics Committee based in the UK) we’ve been impressed by the thought and work put into this aspect of research ethics, we’ve continued to have concerns about the suitability and effectiveness of consent processes in supporting decision making, particularly for clinical trials. There’s poor understanding of what people want to help them decide; current processes don’t provide the best grounding for informed consent and there’s inadequate public involvement. We’ve also found a lack of proportionality with researchers failing to adapt consent procedures in proportion to the burdens and consequences of the study. As a result, people are often not best helped to make an informed choice when asked to join a research study. To address these concerns, we considered how we might improve this aspect of research ethics review. Recognising the central importance of the dialogue between the volunteer and researcher, we’ve drawn up a model or flowchart of what we deem good consent practice, proposing consent should be built around four simple steps: Step 1: Introducing the study and the choices: helping the potential participants get an overview of the proposal and introducing the key issues. Step 2: Explaining all the details of the study using the detailed Participant Information Sheet. Step 3: After a gap, if necessary, reviewing and checking understanding. Step 4: Reaching agreement and recording consent. These steps, we believe, could help all involved and this article lays out ways we might improve participant choice while complying with accepted principles and current regulations.","PeriodicalId":38096,"journal":{"name":"Research Ethics","volume":"47 1","pages":"3 - 12"},"PeriodicalIF":1.7,"publicationDate":"2021-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80581191","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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