Ethics & human research最新文献

(Epistemic) Injustice and Resistance in Canadian Research Ethics Governance 加拿大科研伦理治理中的不公正与抵制。

Ethics & human research Pub Date : 2025-01-03 DOI: 10.1002/eahr.60004

Sarah Clairmont, Emily Doerksen, Alize Ece Gunay, Phoebe Friesen

{"title":"(Epistemic) Injustice and Resistance in Canadian Research Ethics Governance","authors":"Sarah Clairmont, Emily Doerksen, Alize Ece Gunay, Phoebe Friesen","doi":"10.1002/eahr.60004","DOIUrl":"10.1002/eahr.60004","url":null,"abstract":"<div>\u0000 \u0000 <p>This article brings a philosophical perspective to bear on issues of research ethics governance as it is practiced and organized in Canada. Insofar as the processes and procedures that constitute research oversight are meant to ensure the ethical conduct of research, they are based on ideas or beliefs about what ethical research entails and about which processes will ensure the ethical conduct of research. These ideas and beliefs make up an epistemic infrastructure underlying Canada's system of research ethics governance, but, we argue, extensive efforts by community members to fill gaps in that system suggest that these ideas may be deficient. Our aim is to make these deficiencies explicit through critical analysis by briefly introducing the philosophical literature on epistemic injustice and ignorance, and by drawing on this literature and empirical evidence to examine how injustice and ignorance show up across three levels of research ethics governance: research ethics boards, regulations, and training. Following this critique, and drawing on insights from the same philosophical tradition, we highlight the work that communities across Canada have done to rewrite and rework how research ethics as a site of epistemic resistance is practiced.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"47 1","pages":"2-19"},"PeriodicalIF":0.0,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11696195/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142923702","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}

引用次数: 0

Ethical Considerations for Conducting Community-Engaged Research with Women Experiencing Homelessness and Incarcerated Women 对无家可归妇女和被监禁妇女进行社区参与研究的伦理考虑。

Ethics & human research Pub Date : 2025-01-03 DOI: 10.1002/eahr.60005

Kirsten Dickins

{"title":"Ethical Considerations for Conducting Community-Engaged Research with Women Experiencing Homelessness and Incarcerated Women","authors":"Kirsten Dickins","doi":"10.1002/eahr.60005","DOIUrl":"10.1002/eahr.60005","url":null,"abstract":"<div>\u0000 \u0000 <p>Since 1979, <i>The Belmont Report</i> has served as a guidebook for ensuring that basic standards for ethical research are upheld. <i>The Belmont Report</i> calls for special protections of vulnerable research participants, such as people who are incarcerated and economically and educationally disadvantaged individuals who are deemed susceptible to exploitation. With a growing focus on health equity and community-engaged approaches in health equity research, efforts to involve vulnerable participants are increasing. Yet there is little understanding of what matters most to vulnerable populations. This study sought to understand, from participant perspectives, ethical considerations when conducting research with two vulnerable populations: women experiencing homelessness and women who are incarcerated. Health care professionals and staff that work closely with homeless and incarcerated populations were also interviewed. The findings from semistructured interviews with these populations underscore the sustained importance of respect for persons, beneficence, and justice, and further highlight the need for self-determination; privacy/confidentiality; continuous consent; fair treatment; benefit-burden balance; nonauthoritarian relationships; and fair access to research participation. Although <i>The Belmont Report</i> durably serves to ethically guide standard conventional research, the <i>Report</i>'s original concepts should be extended to include specific considerations when vulnerable populations are involved in community-engaged research.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"47 1","pages":"20-33"},"PeriodicalIF":0.0,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142923707","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}

引用次数: 0

Investigating Moral Distress in Clinical Research Professionals—A Deep Dive into Troubled Waters 调查临床研究专业人员的道德困扰——深入研究混乱的水域。

Ethics & human research Pub Date : 2025-01-03 DOI: 10.1002/eahr.60006

Elena Bosack, Dawn Bourne, Elizabeth Epstein, Mary Faith Marshall, Donna T. Chen

{"title":"Investigating Moral Distress in Clinical Research Professionals—A Deep Dive into Troubled Waters","authors":"Elena Bosack, Dawn Bourne, Elizabeth Epstein, Mary Faith Marshall, Donna T. Chen","doi":"10.1002/eahr.60006","DOIUrl":"10.1002/eahr.60006","url":null,"abstract":"<div>\u0000 \u0000 <p>Moral distress occurs when professionals are constrained from taking what they believe to be ethically appropriate actions or are forced to take actions they believe are ethically inappropriate, challenging their professional identities and representing systems-level issues within organizations. Moral distress has been recognized in a variety of health care-related fields; however, the phenomenon is still comparatively unexplored among clinical research professionals (CRPs). In this qualitative study, we interviewed ten CRPs to unearth root causes of moral distress in this ethically unique profession. Four themes emerged from the data as contributors to moral distress: commodification of research; concern for research participants; compromised science; and structures of hierarchy. The experience of racism as a source of moral distress is also explored. The findings of this study indicate that the existence of moral distress in clinical research is troubling not only for the welfare of CRPs but also for the greater clinical research enterprise.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"47 1","pages":"34-45"},"PeriodicalIF":0.0,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11696204/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142923710","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}

引用次数: 0

The European Health Data Space as a Case Study 欧洲健康数据空间案例研究。

Ethics & human research Pub Date : 2024-11-13 DOI: 10.1002/eahr.500228

Edward S. Dove

引用次数: 0

Ethical Issues Faced by Data Monitoring Committees: Results from an Exploratory Qualitative Study 数据监控委员会面临的伦理问题：一项探索性定性研究的结果。

Ethics & human research Pub Date : 2024-11-13 DOI: 10.1002/eahr.500227

Seema K. Shah, Akram Ibrahim, Alex Hinga, Diego Vintimilla, Mickayla Jones, Annette Rid, Lisa Eckstein, Dorcas Kamuya

{"title":"Ethical Issues Faced by Data Monitoring Committees: Results from an Exploratory Qualitative Study","authors":"Seema K. Shah, Akram Ibrahim, Alex Hinga, Diego Vintimilla, Mickayla Jones, Annette Rid, Lisa Eckstein, Dorcas Kamuya","doi":"10.1002/eahr.500227","DOIUrl":"10.1002/eahr.500227","url":null,"abstract":"<div>\u0000 \u0000 <p>To protect research participants and ensure scientific integrity in clinical trials, independent data monitoring committees (DMCs, also known as data and safety monitoring boards) increasingly oversee randomized clinical trials and recommend modifying or stopping research. Little is known about the ethical issues DMCs face. We conducted semistructured interviews of DMC members using a qualitative description approach with low-inference interpretation. We recruited respondents through consultation with experts, an online registry of DMC members, and snowball sampling. We interviewed 22 DMC members who were statisticians, clinicians, and/or ethicists that had overseen a wide variety of trials globally. We identified three themes: finding common ground on responsibilities with variation; the need for judgment but not necessarily ethics expertise; and the resulting emotional distress from navigating ethical challenges. In the first case, DMC members identified 19 distinct duties, with some ethical responsibilities rarely mentioned. In the second case, not all DMC members saw the need for ethicists on DMCs or ethics training. In the third case, ethical challenges sometimes led to strong negative emotions. Developing tailored ethics training and decision-making procedures may help DMCs respond more effectively to ethical challenges.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"46 6","pages":"2-13"},"PeriodicalIF":0.0,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.500227","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142630007","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}

引用次数: 0

The Prospect of Artificial Intelligence-Supported Ethics Review 人工智能支持伦理审查的前景。

Ethics & human research Pub Date : 2024-11-13 DOI: 10.1002/eahr.500230

Philip J. Nickel

引用次数: 0

The Ethical Case for Decentralized Clinical Trials 分散式临床试验的伦理案例。

Ethics & human research Pub Date : 2024-11-13 DOI: 10.1002/eahr.500229

Kathryn Muyskens, Ivan Z. Y. Teo, Jerry Menikoff, G. Owen Schaefer

引用次数: 0

The First- and Second-Order Ethical Reasons Approach: The Case of Human Challenge Trials 一阶和二阶伦理理由法：人体挑战试验案例

Ethics & human research Pub Date : 2024-09-15 DOI: 10.1002/eahr.500223

Davide Battisti, Emma Capulli, Mario Picozzi

{"title":"The First- and Second-Order Ethical Reasons Approach: The Case of Human Challenge Trials","authors":"Davide Battisti, Emma Capulli, Mario Picozzi","doi":"10.1002/eahr.500223","DOIUrl":"https://doi.org/10.1002/eahr.500223","url":null,"abstract":"<div>\u0000 \u0000 <p>At the height of the Covid pandemic, there was much discussion in the literature about using human challenge trials (HCTs) to expedite the development of effective Covid-19 vaccines. Historically, reluctance to fully accept HCTs has largely been due to potential conflicts with the principle of nonmaleficence in bioethics. Only a few commentators have explored this topic in depth. In this paper, we claim that to address ethical concerns regarding HCTs, two types of ethical reasons should be identified and investigated: first-order reasons that can be given to claim that a practice in itself is in direct conflict with the principles of bioethics; and second-order reasons that take into consideration how a practice is carried out and its consequences. We argue that understanding these ethical reasons is crucial for guiding the implementation of HCTs. We investigate a first-order reason against HCTs when the practice is in conflict with the principle of nonmaleficence, and when it is not. Following this argument and assuming there is no first-order reason based on nonmaleficence that hinders using HCTs, we argue there may be second-order reasons to guide implementation of this practice, such as difficulty in obtaining informed consent; protection of the weaker party; and trust in the scientific enterprise.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"46 5","pages":"26-36"},"PeriodicalIF":0.0,"publicationDate":"2024-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.500223","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142244929","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}

引用次数: 0

Translational Bioethics in China: Brain-Computer Interface Research as a Case Study 中国的转化生命伦理学：以脑机接口研究为例

Ethics & human research Pub Date : 2024-09-15 DOI: 10.1002/eahr.500224

Haidan Chen

引用次数: 0

Ethical Considerations for Enrolling “Invested Parties” in Large-Scale Clinical Studies: Insights from the RECOVER Initiative 将 "投资方 "纳入大规模临床研究的伦理考虑因素：来自 RECOVER 计划的启示

Ethics & human research Pub Date : 2024-09-15 DOI: 10.1002/eahr.500221

Kellie Owens, Emily E. Anderson, Shari Esquenazi-Karonika, Keith Hanson, Maika Mitchell, Janelle Linton, Jasmine Briscoe, Leah Castro Baucom, Liza Fisher, Rebecca Letts, Kian Nguyen, Brendan Parent

{"title":"Ethical Considerations for Enrolling “Invested Parties” in Large-Scale Clinical Studies: Insights from the RECOVER Initiative","authors":"Kellie Owens, Emily E. Anderson, Shari Esquenazi-Karonika, Keith Hanson, Maika Mitchell, Janelle Linton, Jasmine Briscoe, Leah Castro Baucom, Liza Fisher, Rebecca Letts, Kian Nguyen, Brendan Parent","doi":"10.1002/eahr.500221","DOIUrl":"https://doi.org/10.1002/eahr.500221","url":null,"abstract":"<div>\u0000 \u0000 <p>Research institutions often lack policies addressing the risks and benefits of enrolling “invested parties” such as investigators, research staff, and patient, caregiver, and community representatives (groups most affected by a disease or intervention) in studies where they have direct involvement. Invested parties may have both strong motivations to study the condition or intervention and to participate as study subjects. More guidance is needed to promote appropriate access to research participation and mitigate potential risks. This article addresses the gap in guidance by presenting an ethical framework and practical guidelines for the enrollment of invested parties. Drawing from experiences with the Researching COVID to Enhance Recovery (RECOVER) Initiative, a large multisite observational cohort study, we argue that invested parties should not be categorically excluded from enrollment in their own research studies if certain criteria are met and appropriate safeguards are in place. We underscore the need to balance inclusion with fairness, promote valid voluntary informed consent, ensure data privacy, protect scientific validity, and mitigate unique risks to invested parties as participants. Additionally, we recommend regular reporting and empirical assessment to evaluate the impact of enrolling invested parties on participants and study outcomes.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"46 5","pages":"2-12"},"PeriodicalIF":0.0,"publicationDate":"2024-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.500221","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142244928","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}

引用次数: 0