Ethics & human research最新文献_第5页

Institutional Review Boards' Assessment of Local Context: A Mixed Methods Study 机构审查委员会对当地环境的评估：混合方法研究。

Ethics & human research Pub Date : 2024-01-19 DOI: 10.1002/eahr.500195

Timothy C. Guetterman, Adrianne Haggins, Sacha Montas, Joy Black, Deneil Harney, Michael D. Fetters, Robert Silbergleit, Neal W. Dickert

{"title":"Institutional Review Boards' Assessment of Local Context: A Mixed Methods Study","authors":"Timothy C. Guetterman, Adrianne Haggins, Sacha Montas, Joy Black, Deneil Harney, Michael D. Fetters, Robert Silbergleit, Neal W. Dickert","doi":"10.1002/eahr.500195","DOIUrl":"10.1002/eahr.500195","url":null,"abstract":"<div>\u0000 \u0000 <p>The nature of the review of local context by institutional review boards (IRBs) is vague. Requirements for single IRB review of multicenter trials create a need to better understand interpretation and implementation of local-context review and how to best implement such reviews centrally. We sought a pragmatic understanding of IRB local-context review by exploring stakeholders' attitudes and perceptions. Semistructured interviews with 26 IRB members and staff members, institutional officials, and investigators were integrated with 80 surveys of similar stakeholders and analyzed with qualitative theme-based text analysis and descriptive statistical analysis. Stakeholders described what they considered to be local context, the value of local-context review, and key processes used to implement review of local context in general and for emergency research conducted with an exception from informed consent. Concerns and potential advantages of centralized review of local context were expressed. Variability in perspectives suggests that local-context review is not a discrete process, which presents opportunities for defining pathways for single IRB review.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"46 1","pages":"2-13"},"PeriodicalIF":0.0,"publicationDate":"2024-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.500195","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139492274","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

Positive and Negative Social Consequences of Participating in a Sexual-Network Study 参与性网络研究的积极和消极社会后果。

Ethics & human research Pub Date : 2024-01-19 DOI: 10.1002/eahr.500196

Morgan Spahnie, Amiah Matthews, Dale Kiss, JaNelle Ricks, William Miller, Abigail Norris Turner

{"title":"Positive and Negative Social Consequences of Participating in a Sexual-Network Study","authors":"Morgan Spahnie, Amiah Matthews, Dale Kiss, JaNelle Ricks, William Miller, Abigail Norris Turner","doi":"10.1002/eahr.500196","DOIUrl":"10.1002/eahr.500196","url":null,"abstract":"<div>\u0000 \u0000 <p>Assessment of risks and benefits of study participation is standard practice preceding the initiation of human subjects research. Although tracking adverse events during research participation is routine, collecting information from participants about what they perceive as benefits is less common. We longitudinally tracked social risks and benefits of participation among a cohort of 241 men who have sex with men participating in a sexual health study to improve participants' experiences and enhance understanding of participant motivations to enroll and attend follow-up. Of the participants who returned for at least one follow-up visit (n = 217, 90%), most (n = 185, 85%) reported positive consequences resulting from participation. Reporting of negative social consequences was rare, and all concerned a stigmatized reaction from someone learning about the participant's involvement in a sexual health study. Better identification of both positive and negative consequences resulting from research participation may improve how researchers design, recruit, and conduct research.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"46 1","pages":"14-25"},"PeriodicalIF":0.0,"publicationDate":"2024-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.500196","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139492287","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 Ethics of Using News Stories concerning Minors as Empirical Material in Health Research: Reflections on a Swedish Case 在健康研究中使用有关未成年人的新闻报道作为经验材料的伦理问题：瑞典案例反思

Ethics & human research Pub Date : 2024-01-19 DOI: 10.1002/eahr.500197

Sigrid Stjernswärd, Carola Tilgmann, Stinne Glasdam

引用次数: 0

Moving to the Middle Ground: Redefining Genomic Utility to Expand Understanding of Familial Benefit 走向中间地带：重新定义基因组效用，扩大对家族利益的理解。

Ethics & human research Pub Date : 2024-01-19 DOI: 10.1002/eahr.500199

Kyle B. Brothers, Greg M. Cooper, Katelyn C. McNamara, Amy A. Lemke, Josie Timmons, Carla A. Rich, R. Jean Cadigan, Roselle S. Ponsaran, Aaron J. Goldenberg

引用次数: 0

Navigating Informed Consent Requirements and Expectations in Cluster Randomized Trials: Research Ethics Board Members’ and Researchers’ Views 在集群随机试验中导航知情同意要求和期望:研究伦理委员会成员和研究人员的观点。

Ethics & human research Pub Date : 2023-11-21 DOI: 10.1002/eahr.500189

Anita Ho, Soodabeh Joolaee, Michael McDonald, Don Grant, Michel M. White, Holly Longstaff, Eirikur Palsson

{"title":"Navigating Informed Consent Requirements and Expectations in Cluster Randomized Trials: Research Ethics Board Members’ and Researchers’ Views","authors":"Anita Ho, Soodabeh Joolaee, Michael McDonald, Don Grant, Michel M. White, Holly Longstaff, Eirikur Palsson","doi":"10.1002/eahr.500189","DOIUrl":"10.1002/eahr.500189","url":null,"abstract":"<div>\u0000 \u0000 <p>Informed consent is a cornerstone of ethical human research. However, as cluster randomized trials (CRTs) are increasingly popular to evaluate health service interventions, especially as health systems aspire toward the learning health system, questions abound how research teams and research ethics boards (REBs) should navigate intertwining consent and data-use considerations. Methodological and ethical questions include who constitute the participants, whose and what types of consent are necessary, and how data from people who have not consented to participation should be managed to optimize the balance of trust in the research enterprise, respect for persons, the promotion of data integrity, and the pursuit of the public good in the research arena. In this paper, we report the findings and lessons learned from a qualitative study examining how researchers and REB members consider the ethical dimensions of when data can be collected and used in CRTs in the evolving research landscape.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"45 6","pages":"31-45"},"PeriodicalIF":0.0,"publicationDate":"2023-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.500189","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138291967","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

Should Chatbots Be Used to Obtain Informed Consent for Research? 应该使用聊天机器人来获得研究的知情同意吗?

Ethics & human research Pub Date : 2023-11-21 DOI: 10.1002/eahr.500190

Mark A. Rothstein

引用次数: 0

A Passing Problem: Evaluating Harm and Benefit in Autism Research 一个过时的问题:评估自闭症研究中的危害和益处。

Ethics & human research Pub Date : 2023-11-21 DOI: 10.1002/eahr.500188

Ari Ne'eman, Kenneth A. Richman, Allison M. McCarthy, Daniel Wilkenfeld

{"title":"A Passing Problem: Evaluating Harm and Benefit in Autism Research","authors":"Ari Ne'eman, Kenneth A. Richman, Allison M. McCarthy, Daniel Wilkenfeld","doi":"10.1002/eahr.500188","DOIUrl":"10.1002/eahr.500188","url":null,"abstract":"<div>\u0000 \u0000 <p>Autism research frequently seeks to evaluate interventions or inform their development. Unfortunately, researchers often assume that autism intervention should reduce autistic traits, effectively setting as a goal of treatment that autistic people attempt to “pass” as nonautistic. A growing body of evidence highlights serious potential harms from passing demands. We discuss why it is important for institutional review boards (IRBs) to scrutinize autism research for clinical passing demands, and we document the existence of such demands in outcome measures commonly employed in autism research. We propose an ethical framework for IRBs and others to make use of in evaluating the ethical appropriateness of particular treatment goals in autism intervention or intervention-adjacent research, emphasizing that treatment goals should be in pursuit of a beneficial nonpassing purpose and be the least burdensome means of accomplishing such a purpose. We also highlight potential promising practices for IRBs, investigators, and other stakeholders seeking to address these issues in autism research.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"45 6","pages":"2-18"},"PeriodicalIF":0.0,"publicationDate":"2023-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138291965","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

Exclusion of Women from Phase I Trials: Perspectives from Investigators and Research Oversight Officials 将女性排除在I期试验之外:来自调查人员和研究监督官员的观点。

Ethics & human research Pub Date : 2023-11-21 DOI: 10.1002/eahr.500170

Margaret Waltz, Anne Drapkin Lyerly, Jill A. Fisher

{"title":"Exclusion of Women from Phase I Trials: Perspectives from Investigators and Research Oversight Officials","authors":"Margaret Waltz, Anne Drapkin Lyerly, Jill A. Fisher","doi":"10.1002/eahr.500170","DOIUrl":"10.1002/eahr.500170","url":null,"abstract":"<div>\u0000 \u0000 <p>Over the past 30 years, progress has been made in increasing women's representation in clinical research. However, women continue to be underrepresented in phase I clinical trials—those trials that test the safety and tolerability of investigational drugs, often on healthy individuals. As sex-based differences in adverse drug reactions are often linked to drug dose, pivotal safety information in phase I trials is often insufficiently—and inequitably—captured for females. Yet there has been little attention to how clinical investigators and those charged with overseeing the ethical conduct of these trials perceive the barriers to women's inclusion in phase I trials. To address this gap, we report on 22 interviews with U.S. phase I investigators and institutional review board (IRB) members. Our findings indicate that although these investigators and IRB members acknowledged the importance of including women in clinical trials, they justified women's exclusion from phase I trials by citing the need to manage their reproductive potential. In particular, we identified four key themes that informants used to warrant women's exclusion from phase I trials: the structure of the drug-development system itself, fears about risks to potential fetuses, distrust of women to prevent pregnancy, and concerns about risks and burdens to institutions from resulting pregnancies. We argue that these rationales reflect structural and cultural barriers to women's inclusion in clinical research that ultimately fail to respect female research participants as persons, highlighting the need for broad-based solutions.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"45 6","pages":"19-30"},"PeriodicalIF":0.0,"publicationDate":"2023-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.500170","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138291966","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

Editors’ Statement on the Responsible Use of Generative AI Technologies in Scholarly Journal Publishing 编辑关于在学术期刊出版中负责任地使用生成人工智能技术的声明。

Ethics & human research Pub Date : 2023-10-01 DOI: 10.1002/eahr.500182

Gregory E. Kaebnick, David Christopher Magnus, Audiey Kao, Mohammad Hosseini, David Resnik, Veljko Dubljević, Christy Rentmeester, Bert Gordijn, Mark J. Cherry

{"title":"Editors’ Statement on the Responsible Use of Generative AI Technologies in Scholarly Journal Publishing","authors":"Gregory E. Kaebnick, David Christopher Magnus, Audiey Kao, Mohammad Hosseini, David Resnik, Veljko Dubljević, Christy Rentmeester, Bert Gordijn, Mark J. Cherry","doi":"10.1002/eahr.500182","DOIUrl":"10.1002/eahr.500182","url":null,"abstract":"<div>\u0000 \u0000 <p>Generative artificial intelligence (AI) has the potential to transform many aspects of scholarly publishing. Authors, peer reviewers, and editors might use AI in a variety of ways, and those uses might augment their existing work or might instead be intended to replace it. We are editors of bioethics and humanities journals who have been contemplating the implications of this ongoing transformation. We believe that generative AI may pose a threat to the goals that animate our work but could also be valuable for achieving those goals. In the interests of fostering a wider conversation about how generative AI may be used, we have developed a preliminary set of recommendations for its use in scholarly publishing. We hope that the recommendations and rationales set out here will help the scholarly community navigate toward a deeper understanding of the strengths, limits, and challenges of AI for responsible scholarly work.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"45 5","pages":"39-43"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.500182","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41178677","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 Research and Communities 翻译研究与社区。

Ethics & human research Pub Date : 2023-10-01 DOI: 10.1002/eahr.500181

Megan Doerr, Joon-Ho Yu

引用次数: 0