Ethics & human research最新文献_第2页

Polymedia Literacy and Other Ethical Considerations for Online Ethnographic Research on Social Networking Sites 社交网站上的在线人种学研究的多媒介素养和其他伦理考虑因素

Ethics & human research Pub Date : 2024-09-15 DOI: 10.1002/eahr.500222

Federica Guccini, Marie-Pier Cantin, Ahrrabie Thirunavukkarasu, Gerald P. McKinley

引用次数: 0

Single IRB Review and Local Context Considerations: A Scoping Review 单一 IRB 审查和地方背景考虑因素：范围审查。

Ethics & human research Pub Date : 2024-06-30 DOI: 10.1002/eahr.500215

Stephanie R. Morain, Megan K. Singleton, Kate Tsiandoulas, Juli Bollinger, Jeremy Sugarman

{"title":"Single IRB Review and Local Context Considerations: A Scoping Review","authors":"Stephanie R. Morain, Megan K. Singleton, Kate Tsiandoulas, Juli Bollinger, Jeremy Sugarman","doi":"10.1002/eahr.500215","DOIUrl":"10.1002/eahr.500215","url":null,"abstract":"<div>\u0000 \u0000 <p>A leading concern about single IRB (sIRB) review for multisite studies, as is now required by federal policies, is whether and how sIRBs consider local context in their review. While several types of local context considerations have been proposed, there is no shared agreement among those charged with the ethics oversight of human subjects research as to the goals and content of local context review, nor the types of research studies for which sIRB review might be inappropriate. Through a scoping review of published scholarship, public comments, and federal guidance documents, we identified five assumed goals for local context review: protecting the rights and welfare of local participants; ensuring compliance with applicable laws and policies; assessing feasibility; promoting the quality of research; and promoting procedural justice. While a variety of content was proposed to be relevant, it was largely grouped into four domains: population/participant-level characteristics; investigator and research team characteristics; institution-level characteristics; and state and local laws. Proposed characteristics for exclusion from sIRB requirements reflected both protection- and efficiency-based concerns. These findings can inform ongoing efforts to assess the implications of policies mandating sIRB review, and when exceptions to those policies might be appropriate.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"46 4","pages":"17-26"},"PeriodicalIF":0.0,"publicationDate":"2024-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141471298","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

Rationale and Study Checklist for Ethical Rejection of Participants on Crowdsourcing Research Platforms 众包研究平台上拒绝参与者的伦理理由和研究清单。

Ethics & human research Pub Date : 2024-06-30 DOI: 10.1002/eahr.500217

Jon Agley, Casey Mumaw, Bethany Johnson

{"title":"Rationale and Study Checklist for Ethical Rejection of Participants on Crowdsourcing Research Platforms","authors":"Jon Agley, Casey Mumaw, Bethany Johnson","doi":"10.1002/eahr.500217","DOIUrl":"10.1002/eahr.500217","url":null,"abstract":"<div>\u0000 \u0000 <p>Online participant recruitment (“crowdsourcing”) platforms are increasingly being used for research studies. While such platforms can rapidly provide access to large samples, there are concomitant concerns around data quality. Researchers have studied and demonstrated means to reduce the prevalence of low-quality data from crowdsourcing platforms, but approaches to doing so often involve rejecting work and/or denying payment to participants, which can pose ethical dilemmas. We write this essay as an associate professor and two institutional review board (IRB) directors to provide a perspective on the competing interests of participants/workers and researchers and to propose a checklist of steps that we believe may support workers' agency on the platform and lessen instances of unfair consequences to them while enabling researchers to definitively reject lower-quality work that might otherwise reduce the likelihood of their studies producing true results. We encourage further, explicit discussion of these issues among academics and among IRBs.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"46 4","pages":"38-46"},"PeriodicalIF":0.0,"publicationDate":"2024-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.500217","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141471296","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

Patient-Reported Outcome Measures in Routine Clinical Practice: Practical Guidance for Institutional Review Boards 常规临床实践中的患者报告结果测量：机构审查委员会实用指南》。

Ethics & human research Pub Date : 2024-06-30 DOI: 10.1002/eahr.500216

Justin M. Bachmann, Molly A. Shiflet, Julia R. Palacios, Robert W. Turer, Grace H. Wallace, S. Trent Rosenbloom, Todd W. Rice

{"title":"Patient-Reported Outcome Measures in Routine Clinical Practice: Practical Guidance for Institutional Review Boards","authors":"Justin M. Bachmann, Molly A. Shiflet, Julia R. Palacios, Robert W. Turer, Grace H. Wallace, S. Trent Rosenbloom, Todd W. Rice","doi":"10.1002/eahr.500216","DOIUrl":"10.1002/eahr.500216","url":null,"abstract":"<div>\u0000 \u0000 <p>The use of patient-reported outcome measures (PROMs) is increasingly common in routine clinical practice. As tools to quantify symptoms and health status, PROMs play an important role in focusing health care on outcomes that matter to patients. The uses of PROM data are myriad, ranging from clinical care to survey-based research and quality improvement. Discerning the boundaries between these use cases can be challenging for institutional review boards (IRBs). In this article, we provide a framework for classifying the three primary PROM use cases (clinical care, human subjects research, and quality improvement) and discuss the level of IRB oversight (if any) necessary for each. One of the most important considerations for IRB staff is whether PROMs are being used primarily for clinical care and thus do not constitute human subjects research. We discuss characteristics of PROMs implemented primarily for clinical care, focusing on: data platform; survey location; questionnaire length; patient interface; and clinician interface. We also discuss IRB oversight of projects involving the secondary use of PROM data that were collected during the course of clinical care, which span human subjects research and quality improvement. This framework provides practical guidance for IRB staff as well as clinicians who use PROMs as communication aids in routine clinical practice.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"46 4","pages":"27-37"},"PeriodicalIF":0.0,"publicationDate":"2024-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.500216","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141471295","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

Research with Refugee Populations in North America: Applying the NIH Guiding Principles for Ethical Research 北美难民研究：应用美国国立卫生研究院伦理研究指导原则。

Ethics & human research Pub Date : 2024-06-30 DOI: 10.1002/eahr.500214

Julie M. Aultman, Najah Zaaeed, Colleen Payton, Brittany DiVito, Tim Holland, Jacob Atem

{"title":"Research with Refugee Populations in North America: Applying the NIH Guiding Principles for Ethical Research","authors":"Julie M. Aultman, Najah Zaaeed, Colleen Payton, Brittany DiVito, Tim Holland, Jacob Atem","doi":"10.1002/eahr.500214","DOIUrl":"10.1002/eahr.500214","url":null,"abstract":"<div>\u0000 \u0000 <p>This article examines the ethics of research design and the initiation of a study (e.g., recruitment of participants) involving refugee participants. We aim to equip investigators and members of IRBs with a set of ethical considerations and pragmatic recommendations to address challenges in refugee-focused research as it is developed and prepared for IRB review. We discuss challenges including how refugees are being defined and identified; their vulnerabilities before, during, and following resettlement that impacts their research participation; recruitment; consent practices including assent and unaccompanied minors; and conflicts of interest. Ethical guidance and regulatory oversight provided by international bodies, federal governments, and IRBs are important for enforcing the protection of participants. We describe the need for additional ethical guidance and awareness, if not special protections for refugee populations as guided by the National Institutes of Health (NIH) Guiding Principles for Ethical Research.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"46 4","pages":"2-16"},"PeriodicalIF":0.0,"publicationDate":"2024-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.500214","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141471297","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 Bioethical Decision-Making: Human Brain Organoids as a Case Study 转化生物伦理决策：人脑器官模型案例研究》。

Ethics & human research Pub Date : 2024-06-30 DOI: 10.1002/eahr.500218

John H. Evans

引用次数: 0

What Is “Key Information”? Consideration of the Reasons People Do or Do Not Take Part in Research 什么是 "关键信息"？考虑人们参与或不参与研究的原因

Ethics & human research Pub Date : 2024-04-17 DOI: 10.1002/eahr.500210

Kara Berwanger, Jon F. Merz

引用次数: 0

Should Children Be Included in Human Challenge Studies? 人类挑战研究是否应包括儿童？

Ethics & human research Pub Date : 2024-04-17 DOI: 10.1002/eahr.500208

Ariella Binik

{"title":"Should Children Be Included in Human Challenge Studies?","authors":"Ariella Binik","doi":"10.1002/eahr.500208","DOIUrl":"https://doi.org/10.1002/eahr.500208","url":null,"abstract":"<div>\u0000 \u0000 <p>Human challenge studies, in which human research subjects are intentionally exposed to pathogens to contribute to scientific knowledge, raise many ethical complexities. One controversial question is whether it is ethically permissible to include children as participants. Commentary of the past decades endorses the exclusion of children, while new guidance suggests that pediatric human challenge studies can be ethically permissible. This paper argues that neither children's exclusion nor their inclusion are well justified. I examine and reject three arguments for exclusion, but suggest that these arguments establish pediatric human challenge studies as a complex ethical category of research that requires caution. I then argue for a strong presumption against children's inclusion, by drawing on an analogy to children's inclusion in phase I trials, emphasizing a requirement of necessity, and suggesting that accommodating children's vulnerability promotes an age de-escalation approach for pediatric human challenge studies research. In the final section, I suggest a procedure for ethics review.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"46 3","pages":"2-15"},"PeriodicalIF":0.0,"publicationDate":"2024-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.500208","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140559742","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

Ethics in Mental Health Research with Haitian Migrants: Lessons from a Community-Based Study in Santiago, Chile 海地移民心理健康研究中的伦理问题：智利圣地亚哥社区研究的启示

Ethics & human research Pub Date : 2024-04-17 DOI: 10.1002/eahr.500209

Francesca McLaren, Mercedes Mercado, Nicolás Montalva, Loreto Watkins, Andy Antipichun, Judeline Cheristil, Teresita Rocha-Jiménez

{"title":"Ethics in Mental Health Research with Haitian Migrants: Lessons from a Community-Based Study in Santiago, Chile","authors":"Francesca McLaren, Mercedes Mercado, Nicolás Montalva, Loreto Watkins, Andy Antipichun, Judeline Cheristil, Teresita Rocha-Jiménez","doi":"10.1002/eahr.500209","DOIUrl":"https://doi.org/10.1002/eahr.500209","url":null,"abstract":"<div>\u0000 \u0000 <p>Migration research poses several unique challenges and opportunities. Conducting ethical global health practice, especially when studying migrant mental health, is of particular concern. This article explores seven challenges and lessons learned in our mixed-methods study conducted to assess the impact of the migration experience on Haitian migrants’ mental health in Santiago, Chile. The primary challenges were recruiting in a highly mobile population, building trust and community participation, overcoming language barriers, safety considerations during the Covid-19 pandemic, mitigating potential negative impacts of research on the community, providing psychological support, and finding meaningful ways to benefit the community. We propose moving toward a better and more ethical migrant research practice by ensuring language accessibility, hiring community members for the study team, working with local institutions and nongovernmental organizations, and maintaining sustainable connections.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"46 3","pages":"16-25"},"PeriodicalIF":0.0,"publicationDate":"2024-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140559743","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

Translational Research and Health Equity: Gene Therapies for Sickle Cell Disease as a Case Study 转化研究与健康公平：镰状细胞病基因疗法案例研究

Ethics & human research Pub Date : 2024-04-17 DOI: 10.1002/eahr.500211

Mary A. Majumder, Titilope Fasipe

引用次数: 0