Ethics & human research最新文献_第5页

Lotteries as Incentives: Prospect Theory in Practice 彩票作为激励：实践中的前景理论。

Ethics & human research Pub Date : 2023-10-01 DOI: 10.1002/eahr.500183

Jon F. Merz JD, PhD

引用次数: 0

Translational Bioethics and Public Input 转化生物伦理学与公众投入

Ethics & human research Pub Date : 2023-06-27 DOI: 10.1002/eahr.500175

John H. Evans

引用次数: 1

The Essential Need for Trust When Transmission Risk Cannot Be Eliminated in HIV-Remission Trials 当艾滋病毒缓解试验不能消除传播风险时，信任的基本需要

Ethics & human research Pub Date : 2023-06-27 DOI: 10.1002/eahr.500172

Stuart Rennie, Gail Henderson, Nittaya Phanuphak, Kristine Kuczynski, Donn Colby, Nuchanart Ormsby, Eugene Kroon, Denise Hsu, Udom Likhitwonnawut, Sandhya Vasan, Carlo Sacdalan, Thidarat Jupimai, Oratai Butterworth, Holly Peay

{"title":"The Essential Need for Trust When Transmission Risk Cannot Be Eliminated in HIV-Remission Trials","authors":"Stuart Rennie, Gail Henderson, Nittaya Phanuphak, Kristine Kuczynski, Donn Colby, Nuchanart Ormsby, Eugene Kroon, Denise Hsu, Udom Likhitwonnawut, Sandhya Vasan, Carlo Sacdalan, Thidarat Jupimai, Oratai Butterworth, Holly Peay","doi":"10.1002/eahr.500172","DOIUrl":"10.1002/eahr.500172","url":null,"abstract":"<div>\u0000 \u0000 <p>Analytic treatment interruption (ATI) is scientifically necessary in HIV-remission (“cure”) studies to test the effects of new interventions. However, stopping antiretroviral treatment poses risks to research participants and their sexual partners. Ethical debate about whether and how to conduct such studies has largely centered on designing risk-mitigation strategies and identifying the responsibilities of research stakeholders. In this paper, we argue that because the possibility of HIV transmission from research participants to partners during ATI cannot practicably be eliminated—that is, it is ineliminable—the successful conduct of such trials ultimately depends on relationships of trust and trustworthiness. We describe our experiences with conducting and studying HIV-remission trials with ATI in Thailand to examine the strengths, complexities, and limitations of the risk-mitigation and responsibility approaches and to explore ways in which the building of trust—and trustworthiness—may help enhance the scientific, practical, and ethical dimensions of these trials.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"45 4","pages":"2-15"},"PeriodicalIF":0.0,"publicationDate":"2023-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9748144","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: 2

Antiracist Structural Intervention at the Emory University Institutional Review Board 埃默里大学机构审查委员会的反种族主义结构性干预

Ethics & human research Pub Date : 2023-06-27 DOI: 10.1002/eahr.500174

Francois Rollin, Vanessa Van Doren, Jessica Alvarez, Rebecca Rousselle, Jada Bussey-Jones

{"title":"Antiracist Structural Intervention at the Emory University Institutional Review Board","authors":"Francois Rollin, Vanessa Van Doren, Jessica Alvarez, Rebecca Rousselle, Jada Bussey-Jones","doi":"10.1002/eahr.500174","DOIUrl":"10.1002/eahr.500174","url":null,"abstract":"<div>\u0000 \u0000 <p>Although racial and ethnic categories are social constructs without inherent biologic or genetic meaning, race and ethnicity impact health outcomes through racism. The use of racial categories in biomedical research often misattributes the cause of health inequities to genetic and inherent biological differences rather than to racism. Improving research practices around race and ethnicity is an urgent priority and requires education as well as structural change. We describe an evidence-based intervention for an institutional review board (IRB). Our IRB now requires all biomedical study protocols to define racial and ethnic classifications they plan to use, to state whether they are describing or explaining differences between groups, and to provide justification for any use of racial or ethnic group variables as covariates. This antiracist IRB intervention is an example of how research institutions can help ensure the scientific validity of studies and avoid the unscientific reification of race and ethnicity as inherently biological or genetic concepts.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"45 4","pages":"30-34"},"PeriodicalIF":0.0,"publicationDate":"2023-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9748140","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

Factors Associated with IRB Review Time in a Non-Federally Funded Study Using an sIRB of Record 在使用sIRB记录的非联邦资助研究中与IRB审查时间相关的因素

Ethics & human research Pub Date : 2023-06-27 DOI: 10.1002/eahr.500173

Erin Lamers-Johnson, Vanessa K. Will, Julie M. Long, Lindsay Woodcock, Kathryn Kelley, Alison L. Steiber, Elizabeth Yakes Jimenez

{"title":"Factors Associated with IRB Review Time in a Non-Federally Funded Study Using an sIRB of Record","authors":"Erin Lamers-Johnson, Vanessa K. Will, Julie M. Long, Lindsay Woodcock, Kathryn Kelley, Alison L. Steiber, Elizabeth Yakes Jimenez","doi":"10.1002/eahr.500173","DOIUrl":"10.1002/eahr.500173","url":null,"abstract":"<div>\u0000 \u0000 <p>From 2018 to 2020, U.S. federal mandates began requiring the use of a single institutional review board (sIRB) of record for federally funded, multisite studies. With an interest in the efficiency of site activation, we compared the frequency with which local review and approval and three different reliance options (ways to establish a reliance agreement between the sIRB and the relying institution) were used during this period in a multisite, non-federally funded study (ClinicalTrials.gov identifier: NCT03928548). Using general linear models, we analyzed the relationships between local reliance or approval and sIRB of record approval times and (a) the regulatory option selected and (b) relying-site and process characteristics. Eighty-five sites received sIRB approval through 72 submissions (40% using local review, 46% using the SMART IRB agreement, 10% using an IRB authorization agreement, and 4% using a letter of support). Median time to establish a local reliance or study approval and sIRB approval were longest for sites using a SMART IRB agreement. Study-site region and the time of submission were significantly associated with local reliance or approval time, which averaged 129 and 107 days faster for Midwestern (p = 0.03) or Western (p = 0.02) sites, respectively, and 70 days slower for Northeastern sites (p = 0.42) compared with sites in the South, and 91 days slower when regulatory communication was initiated during or after February 2019 compared with before (p = 0.02). Similar relationships between sIRB approval time and region and time frame were observed; in addition, approval time was 103 days slower for sites affiliated with a research 1 (R1) university versus not (p = 0.02). Region of the country, time frame, and R1 university affiliation were associated with variations in study-site activation in a non-federally funded, multisite study.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"45 4","pages":"16-29"},"PeriodicalIF":0.0,"publicationDate":"2023-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10054475","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

A Competency Framework for Health Research Ethics Educational Programs: Results from a Stakeholder-Driven Mixed-Method Process 健康研究伦理教育计划的能力框架:来自利益相关者驱动的混合方法过程的结果

Ethics & human research Pub Date : 2023-05-11 DOI: 10.1002/eahr.500166

Sean Tackett, Chirk Jenn Ng, Jeremy Sugarman, Esther Gnanamalar Sarojini Daniel, Nishakanthi Gopalan, Tivyashinee, Adeeba Kamarulzaman, Joseph Ali

{"title":"A Competency Framework for Health Research Ethics Educational Programs: Results from a Stakeholder-Driven Mixed-Method Process","authors":"Sean Tackett, Chirk Jenn Ng, Jeremy Sugarman, Esther Gnanamalar Sarojini Daniel, Nishakanthi Gopalan,  Tivyashinee, Adeeba Kamarulzaman, Joseph Ali","doi":"10.1002/eahr.500166","DOIUrl":"10.1002/eahr.500166","url":null,"abstract":"<div>\u0000 \u0000 <p>Educational programs are integral to building health research ethics (HRE) capacity, but no outcomes framework exists to guide them. We empirically developed a competency framework for health research ethics education—the Framework for Research Ethics Studies Competencies and Outcomes (FRESCO)—using mixed methods, including group concept mapping and a survey of international experts. FRESCO includes seven competency domains: (1) Foundational Knowledge; (2) Laws, Regulations, Guidelines, and Policies for Research Oversight; (3) Ethical-Issue Identification, Analysis, and Resolution; (4) Engagement, Communication, and Advocacy; (5) Lifelong Learning, Education, Research, and Scholarship; (6) Coordination, Stewardship, and Responsiveness in HRE Systems; and (7) Impartiality, Honesty, and Responsibility. These domains are detailed in 27 subdomains. Survey respondents rated FRESCO's relevance to HRE highly. FRESCO can be adapted and implemented in educational programs to refine recruitment and selection processes, educational and assessment methods, and performance measures to ensure that HRE educational programs have their intended effects.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"45 3","pages":"29-39"},"PeriodicalIF":0.0,"publicationDate":"2023-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.500166","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9542980","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 and Health Privacy 转化生物伦理与健康隐私

Ethics & human research Pub Date : 2023-05-11 DOI: 10.1002/eahr.500167

Mark A. Rothstein

引用次数: 0

Making an Advance Research Directive: An Interview Study with Adults Aged 55 and Older with Interests in Dementia Research 制定预先研究指示:对55岁及以上对痴呆症研究感兴趣的成年人的访谈研究

Ethics & human research Pub Date : 2023-05-11 DOI: 10.1002/eahr.500171

Nola M. Ries, Briony Johnston

{"title":"Making an Advance Research Directive: An Interview Study with Adults Aged 55 and Older with Interests in Dementia Research","authors":"Nola M. Ries, Briony Johnston","doi":"10.1002/eahr.500171","DOIUrl":"10.1002/eahr.500171","url":null,"abstract":"<div>\u0000 \u0000 <p>Many people with dementia are interested in taking part in research, including when they no longer have capacity to provide informed consent. Advance research directives (ARD) enable people to document their wishes about research participation prior to becoming decisionally incapacitated. However, there are few available ARD resources. This Australian interview study elicited the views of people aged 55 years and older about the content of an ARD form and guidance booklet and processes to support research planning. Participants (n = 25; 55 to 83 years) had interests in dementia research. All participants described the ARD materials as easy to understand, and all expressed willingness to take part in future research. Nearly half believed that an ARD should be legally enforceable, while others saw it as a nonbinding document to guide decisions about their participation in research. Close family members were preferred as proxy decision-makers. The ARD form and guidance booklet may be adapted for use elsewhere.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"45 3","pages":"2-17"},"PeriodicalIF":0.0,"publicationDate":"2023-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.500171","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9459699","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

Offering Lottery Entry as an Incentive for Research Participation Compromises Informed Consent 提供抽奖作为研究参与的激励损害了知情同意

Ethics & human research Pub Date : 2023-05-11 DOI: 10.1002/eahr.500165

Simon Paul Jenkins

引用次数: 0

Translational Bioethics and Health Privacy. 转化生物伦理与健康隐私。

Ethics & human research Pub Date : 2023-05-01 DOI: 10.2139/ssrn.4405495

M. Rothstein

引用次数: 2