Ethics & human research最新文献_第2页

Building Ethical Foundations in Research: Adaptation of a Research Ethics Training Program for Adolescents 建构研究中的伦理基础：青少年研究伦理训练计划的适应

Ethics & human research Pub Date : 2025-03-14 DOI: 10.1002/eahr.60001

Angela K. S. Gummadi, Kirstin Griffin, Farah Contractor, Jessica Forrester, Irène P. Mathieu

{"title":"Building Ethical Foundations in Research: Adaptation of a Research Ethics Training Program for Adolescents","authors":"Angela K. S. Gummadi, Kirstin Griffin, Farah Contractor, Jessica Forrester, Irène P. Mathieu","doi":"10.1002/eahr.60001","DOIUrl":"https://doi.org/10.1002/eahr.60001","url":null,"abstract":"<div>\u0000 \u0000 <p>Although young people are increasingly being included in research that affects them, commonly used research ethics training programs are designed for highly educated adult learners. In this paper, we describe our process of adapting and implementing an adolescent-appropriate version of an existing Collaborative Institutional Training Initiative (CITI) training module. Our research team adapted content from the CITI program's Researcher Basic Course—No Prisoners. Based on consultation with our youth researchers, this comprehensive training included audiovisual storytelling and information delivery, incorporation of relevant examples and connections to our research project, and interactive discussions. We successfully adapted a research ethics training for a nonacademic youth audience in partnership with them. Our adaptation was acceptable to participating youth researchers who reported greater understanding of ethical issues in social-behavioral research, increased understanding regarding the safeguarding of human subjects, and heightened confidence in their research abilities. Meaningful community and youth engagement in research necessitate the adaptation of training modules and materials that are accessible and appropriate for nonacademic audiences. We demonstrate the feasibility and success of one such adaptation for a youth participatory action research team involved in a study of adolescent mental health.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"47 2","pages":"34-40"},"PeriodicalIF":0.0,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.60001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143622703","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

Brain Organoid Research in a Post-Dobbs World 后多布斯时代的脑类器官研究

Ethics & human research Pub Date : 2025-03-14 DOI: 10.1002/eahr.60017

Christine N. Coughlin, Nancy M. P. King, Emily McEwan

引用次数: 0

Stakeholder Views on Novel Consent Forms for an Acute Stroke Trial 利益相关者对急性中风试验新同意书的意见

Ethics & human research Pub Date : 2025-03-14 DOI: 10.1002/eahr.60015

Candace D. Speight, Opeolu M. Adeoye, S. Iris Davis, Michael J. Linke, Andrea R. Mitchell, Neal W. Dickert

{"title":"Stakeholder Views on Novel Consent Forms for an Acute Stroke Trial","authors":"Candace D. Speight, Opeolu M. Adeoye, S. Iris Davis, Michael J. Linke, Andrea R. Mitchell, Neal W. Dickert","doi":"10.1002/eahr.60015","DOIUrl":"https://doi.org/10.1002/eahr.60015","url":null,"abstract":"<div>\u0000 \u0000 <p>Lengthy consent forms are poorly suited for clinical trials in emergency contexts; however, innovations in consent processes are challenging to implement. A previously developed, context-sensitive consent form and information sheet were approved by a single institutional review board (sIRB) of record for use in a multisite stroke treatment clinical trial. This study sought views on using these materials by research teams and representatives from local institutional review boards (IRBs) and human research protection programs (HRPPs). Semistructured interviews were conducted with 22 local IRB/HRPP respondents and study team members from various study sites. Study teams appreciated the abbreviated length of the consent form and how the information tailored to help patients’ decisions was included while supplementary information was placed in an information sheet. They also described positive impacts on their interactions and processes; IRB/HRPP respondents valued the simplicity of the language, formatting, and attention to what was in the consent form versus what was on the information sheet. They supported the efforts and questioned whether local IRBs would have given approval. Some respondents were unsure of how to best use the information sheet. The consent forms were found to be patient-centered and implementable by study teams. Further experience is needed to identify optimal ways of incorporating supplemental written information. Since many of the IRB/HRPP respondents were uncertain whether their local IRBs would have approved the consent materials that were approved by the sIRB, these findings reinforce the potential for sIRB processes to facilitate the implementation of innovative approaches to consent.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"47 2","pages":"16-25"},"PeriodicalIF":0.0,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143622655","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

Financial Toxicity in Early Phase Oncology Clinical Trials: A Review and Ethical Analysis 早期肿瘤临床试验的财务毒性：综述和伦理分析

Ethics & human research Pub Date : 2025-03-14 DOI: 10.1002/eahr.60016

Leigh E. Meyer, Erin S. DeMartino, Colt Williams

{"title":"Financial Toxicity in Early Phase Oncology Clinical Trials: A Review and Ethical Analysis","authors":"Leigh E. Meyer, Erin S. DeMartino, Colt Williams","doi":"10.1002/eahr.60016","DOIUrl":"https://doi.org/10.1002/eahr.60016","url":null,"abstract":"<div>\u0000 \u0000 <p>Of the many burdens cancer patients face, the impact on personal finances is often invisible to clinicians. <i>Financial toxicity</i> refers to the negative impact on patients’ and families’ quality of life due to a combination of high out-of-pocket costs of medical treatment, diminished savings, and psychological distress as a result of diminished finances. Financial toxicity in cancer care has been more closely examined in the standard-of-care setting. Financial toxicity in the early phase clinical trial setting, and the ethical implications of making patients pay out of pocket to access experimental interventions that may not have therapeutic benefit, have yet to be explored. This article seeks to highlight hidden costs of clinical trial participation in the U.S., and to illustrate how patients are susceptible to financial toxicity from nonmedical direct costs and indirect costs even though a trial intervention itself is not charged to the patient. We argue that not informing prospective participants of the potential costs of trial participation threatens their autonomy and interferes with researchers’ prima facie duties to beneficence and nonmaleficence.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"47 2","pages":"26-33"},"PeriodicalIF":0.0,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143622662","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

Expectations, Tensions, and Brokerage: A Discourse Analysis of Community Engagement with Health Research in South Africa 期望、紧张和中介：南非社区参与健康研究的话语分析

Ethics & human research Pub Date : 2025-03-14 DOI: 10.1002/eahr.60012

Sonja Klingberg, Catherine E. Draper

{"title":"Expectations, Tensions, and Brokerage: A Discourse Analysis of Community Engagement with Health Research in South Africa","authors":"Sonja Klingberg, Catherine E. Draper","doi":"10.1002/eahr.60012","DOIUrl":"https://doi.org/10.1002/eahr.60012","url":null,"abstract":"<div>\u0000 \u0000 <p>Research is increasingly claimed to be done in collaboration with communities, but community members may have entirely different expectations of engagement and research participation than what typically follows the logic of academia. In South Africa, intersecting inequalities further complicate relationships with communities and stakeholders. To understand how different actors view and construct the relationships between academic institutions and communities, we undertook a multiperspective discourse analysis. We conducted 11 in-depth interviews with 12 participants categorized as researchers, community representatives, and community members. These interviews reflect three interconnected discourses: expectations, tensions, and brokerage. <i>Expectations</i> pattern intergroup dynamics, such as community members’ expectations of research benefits, while <i>tensions</i> primarily capture challenging relationships between different research actors. Our analysis also illustrates how, in the absence of comprehensive institutional support, community engagement relies on <i>brokerage</i> by community representatives, and how this reliance disproportionately burdens them. There is a need to lessen this ethical burden and invite community input without also burdening community members and representatives with the challenges of academia. Our findings also have wider relevance for community-based health research because engagement practices are often hindered by institutional and structural factors.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"47 2","pages":"2-15"},"PeriodicalIF":0.0,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.60012","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143622654","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

(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