Ethics & human research最新文献_第3页

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

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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

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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

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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

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

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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