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Big Health Data Research and Group Harm: The Scope of IRB Review 健康大数据研究与群体危害:IRB审查范围
Ethics & human research Pub Date : 2022-07-08 DOI: 10.1002/eahr.500130
Megan Doerr, Sara Meeder
{"title":"Big Health Data Research and Group Harm: The Scope of IRB Review","authors":"Megan Doerr,&nbsp;Sara Meeder","doi":"10.1002/eahr.500130","DOIUrl":"10.1002/eahr.500130","url":null,"abstract":"<div>\u0000 \u0000 <p>Much of precision medicine is driven by big health data research—the analysis of massive datasets representing the complex web of genetic, behavioral, environmental, and other factors that impact human well-being. There are some who point to the Common Rule, the regulation governing federally funded human subjects research, as a regulatory panacea for all types of big health data research. But how well does the Common Rule fit the regulatory needs of this type of research? This article suggests that harms that may arise from artificial intelligence and machine-learning technologies used in big health data research—and the increased likelihood that this research will affect public policy—mean it is time to consider whether the current human research regulations prohibit comprehensive, ethical review of big health data research that may result in group harm.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"44 4","pages":"34-38"},"PeriodicalIF":0.0,"publicationDate":"2022-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.500130","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40482537","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: 6
Ethical Considerations during the Informed Consent Process for Acute Ischemic Stroke in International Clinical Trials 国际临床试验中急性缺血性卒中知情同意过程中的伦理考虑
Ethics & human research Pub Date : 2022-07-08 DOI: 10.1002/eahr.500133
Tiffany Bellomo, Jennifer Fokas, Noah Tsao, Clare Anderson, Christopher Becker, Rachel Gioscia-Ryan, William Meurer
{"title":"Ethical Considerations during the Informed Consent Process for Acute Ischemic Stroke in International Clinical Trials","authors":"Tiffany Bellomo,&nbsp;Jennifer Fokas,&nbsp;Noah Tsao,&nbsp;Clare Anderson,&nbsp;Christopher Becker,&nbsp;Rachel Gioscia-Ryan,&nbsp;William Meurer","doi":"10.1002/eahr.500133","DOIUrl":"10.1002/eahr.500133","url":null,"abstract":"<div>\u0000 \u0000 <p>We sought to investigate the experiences of researchers in existing active-control trials in acute ischemic stroke comparing investigational therapy to tissue plasminogen activator (tPA) in order to identify the approaches and challenges in obtaining informed consent. Out of 401 articles evaluated, 14 trials met inclusion criteria. Trial representatives were contacted to complete a survey concerning the consent process. None of the 14 trials published materials related to the informed consent process. Trials with 75% to 100% of patients directly consented had shorter door-to-treatment (DTT) times than trials that directly consented less than 50% of patients. Trials that had translators available (for recruiting participants who were not native speakers in the local language) and translated consent documents had longer DTT times. The study findings suggest that differences in the standards of informed consent internationally may allow more patients with moderate strokes to provide direct consent without delaying DTT time. Future trials should emphasize transparency to the public and scientific community in the informed consent process.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"44 4","pages":"14-25"},"PeriodicalIF":0.0,"publicationDate":"2022-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40494775","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
Influence of Dispositional Optimism on Ethically Salient Research Perspectives: A Pilot Study 性格乐观对伦理显著性研究视角的影响:一项初步研究
Ethics & human research Pub Date : 2022-05-11 DOI: 10.1002/eahr.500126
Jane Paik Kim, Sangeeta Mondal, Tenzin Tsungmey, Katie Ryan, Laura B. Dunn, Laura Weiss Roberts
{"title":"Influence of Dispositional Optimism on Ethically Salient Research Perspectives: A Pilot Study","authors":"Jane Paik Kim,&nbsp;Sangeeta Mondal,&nbsp;Tenzin Tsungmey,&nbsp;Katie Ryan,&nbsp;Laura B. Dunn,&nbsp;Laura Weiss Roberts","doi":"10.1002/eahr.500126","DOIUrl":"10.1002/eahr.500126","url":null,"abstract":"<div>\u0000 \u0000 <p>Research participants should be drawn as fairly as possible from the potential volunteer population. Underlying personality traits are underexplored as factors influencing research decision-making. Dispositional optimism, known to affect coping, physical health, and psychological well-being, has been minimally studied with respect to research-related attitudes. We conducted an exploratory, online survey with 151 individuals (with self-reported mental illness [n = 50], physical illness [n = 51], or neither [n = 50]) recruited via MTurk. We evaluated associations between dispositional optimism (assessed with the Life Orientation Test—Revised) and general research attitudes, perceived protectiveness of five research safeguards, and willingness to participate in research using safeguards. Strongly optimistic respondents expressed more positive research attitudes and perceived four safeguards as more positively influencing willingness to participate. Optimism was positively associated with expressed willingness to participate in clinical research. Our findings add to a limited literature on the influence of individual traits on ethically salient research perspectives.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"44 3","pages":"12-23"},"PeriodicalIF":0.0,"publicationDate":"2022-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9436640","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
When Is a Change Significant? The Update Problem of Apps in Medical and Behavioral Research 什么时候变化是重要的?医学和行为研究中应用程序的更新问题
Ethics & human research Pub Date : 2022-05-11 DOI: 10.1002/eahr.500118
Carmel Shachar, Sara Gerke, Walker Morrell, Aaron Kirby, I. Glenn Cohen, Barbara E. Bierer
{"title":"When Is a Change Significant? The Update Problem of Apps in Medical and Behavioral Research","authors":"Carmel Shachar,&nbsp;Sara Gerke,&nbsp;Walker Morrell,&nbsp;Aaron Kirby,&nbsp;I. Glenn Cohen,&nbsp;Barbara E. Bierer","doi":"10.1002/eahr.500118","DOIUrl":"10.1002/eahr.500118","url":null,"abstract":"<div>\u0000 \u0000 <p>Digital applications (apps) are commonly used across the research ecosystem. While apps are frequently updated in the course of clinical and behavioral research, there is limited guidance as to when an app update should trigger action related to human research participant protections and who should be responsible for monitoring and reviewing these updates. We term this the “update problem” and argue that, while it is the principal investigator's duty to track all relevant updates, the level of involvement and re-review by the institutional review board (IRB) of an approved research protocol should vary depending on whether the update may be classified as minor, not minor, or significant. Minor updates require at most annual notification of the IRB, updates that are not minor require prompt notification of the IRB, and significant updates may require full board re-review or another response. We also suggest how these policies might be implemented.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"44 3","pages":"2-11"},"PeriodicalIF":0.0,"publicationDate":"2022-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.500118","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73218400","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 Parent-Adolescent Dyadic Research 亲子二元研究的伦理考量
Ethics & human research Pub Date : 2022-05-11 DOI: 10.1002/eahr.500127
Kemesha Gabbidon, Tiffany Chenneville, Wendy Rote
{"title":"Ethical Considerations for Parent-Adolescent Dyadic Research","authors":"Kemesha Gabbidon,&nbsp;Tiffany Chenneville,&nbsp;Wendy Rote","doi":"10.1002/eahr.500127","DOIUrl":"10.1002/eahr.500127","url":null,"abstract":"<div>\u0000 \u0000 <p>Over the last few years, the use of dyadic research methods has expanded considerably. One area that has benefited from this type of research is the study of the family unit, particularly parent-adolescent dyads. Dyadic research allows investigators to assess relationship dynamics, processes, and congruences within a family unit, as well as the distinct experiences of each member of the dyad. However, like all emerging and expanding areas of human subjects research, parent-adolescent dyadic research faces several ethical challenges. Given the advantages of parent-adolescent dyadic research for examining family relational processes, this article addresses ethical challenges experienced by dyadic researchers that often temper interests in applying these approaches. Drawing on the scholarly literature and the authors’ experiences conducting parent-adolescent dyadic research, we discuss heightened and unique ethical challenges that arise in this area of inquiry and provide recommendations on how to best navigate those issues.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"44 3","pages":"24-33"},"PeriodicalIF":0.0,"publicationDate":"2022-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89946990","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: 1
Nothing about Us without Us: Inclusion and IRB Review of Mental Health Research Protocols 没有我们就没有我们:心理健康研究方案的纳入和IRB审查
Ethics & human research Pub Date : 2022-05-11 DOI: 10.1002/eahr.500128
Ian Tully
{"title":"Nothing about Us without Us: Inclusion and IRB Review of Mental Health Research Protocols","authors":"Ian Tully","doi":"10.1002/eahr.500128","DOIUrl":"10.1002/eahr.500128","url":null,"abstract":"<div>\u0000 \u0000 <p>Research on mental health and illness presents a variety of unique ethical challenges. This article argues that institutional review boards (IRBs) can improve their reviews of such research by including the perspectives of individuals with the condition under study either as members of the IRB or as consultants thereto. Several reasons for including the perspectives of these individuals are advanced, with the discussion organized around a hypothetical case study involving the assessment of a novel talk-therapy modality. Having made this case, the article goes on to explain how to implement the idea by building on a recent proposal by Rebecca Dresser, who argues in a number of publications for the inclusion of former research participants in the IRB review process. Finally, concerns about protecting reviewer and consultant confidentiality are addressed.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"44 3","pages":"34-40"},"PeriodicalIF":0.0,"publicationDate":"2022-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78287211","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
Getting the Most out of Consent: Patient-Centered Consent for an Acute Stroke Trial 充分利用同意:急性中风试验中以患者为中心的同意
Ethics & human research Pub Date : 2022-02-26 DOI: 10.1002/eahr.500122
Neal W. Dickert, Kathleen Metz, S. Iris Deeds, Michael J. Linke, Andrea R. Mitchell, Candace D. Speight, Opeolu M. Adeoye
{"title":"Getting the Most out of Consent: Patient-Centered Consent for an Acute Stroke Trial","authors":"Neal W. Dickert,&nbsp;Kathleen Metz,&nbsp;S. Iris Deeds,&nbsp;Michael J. Linke,&nbsp;Andrea R. Mitchell,&nbsp;Candace D. Speight,&nbsp;Opeolu M. Adeoye","doi":"10.1002/eahr.500122","DOIUrl":"10.1002/eahr.500122","url":null,"abstract":"<div>\u0000 \u0000 <p>Informed consent for clinical trials in acute stroke is characterized by challenges related to urgency, cognitive impairment, and geographical separation. Context-appropriate approaches are needed for this setting. We conducted a mixed-methods project involving focus groups and interviews as well as collaboration with a patient advisory panel and a central institutional review board (CIRB) to design and implement a patient-driven consent process for a multicenter trial incorporating adaptive randomization. Remote consent was recognized as challenging but acceptable. Adaptive randomization was viewed positively, but significant potential for misunderstanding was appreciated. Collaboration between the patient advisory panel and the CIRB resulted in a shortened, more patient-centered consent form that was approved at all sites with few modifications. An information sheet was developed as a resource for patients and surrogates after enrollment. Collaboration between investigators, patient partners, and a CIRB can facilitate innovation and implementation of patient-centered, context-appropriate consent strategies.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"44 2","pages":"33-40"},"PeriodicalIF":0.0,"publicationDate":"2022-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78343110","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: 3
Therapeutic Misconception about Research Procedures: Does a Simple Information Chart Improve Understanding? 治疗对研究程序的误解:一个简单的信息图表能增进理解吗?
Ethics & human research Pub Date : 2022-02-26 DOI: 10.1002/eahr.500120
Gavin Campbell, Margie D. Dixon, Minisha Lohani, John Cook, Rachel Hianik, Mary Catherine Thomson, Eli Abernethy, Colleen Lewis, Jeffrey Switchenko, R. Donald Harvey, Rebecca D. Pentz
{"title":"Therapeutic Misconception about Research Procedures: Does a Simple Information Chart Improve Understanding?","authors":"Gavin Campbell,&nbsp;Margie D. Dixon,&nbsp;Minisha Lohani,&nbsp;John Cook,&nbsp;Rachel Hianik,&nbsp;Mary Catherine Thomson,&nbsp;Eli Abernethy,&nbsp;Colleen Lewis,&nbsp;Jeffrey Switchenko,&nbsp;R. Donald Harvey,&nbsp;Rebecca D. Pentz","doi":"10.1002/eahr.500120","DOIUrl":"10.1002/eahr.500120","url":null,"abstract":"<div>\u0000 \u0000 <p>In phase I trials, some biospecimens are used both for research and patient care and some for research only. Some research participants have therapeutic misconception, assuming all biospecimens are for patient care. This study's aim was to test if a simple information chart would improve understanding of nontherapeutic research procedures. A two-arm study was conducted. Participants in the control group (C) were asked whether biospecimens were for their care, for research only, or for both. The experimental group (E) was asked the same questions but provided with a study-specific information chart labeling the purpose of each biospecimen. One hundred one patients were interviewed. In both arms, understanding that pretreatment blood draws were for patient care and research was moderate (49% for C and 62% for E). Understanding that posttreatment blood draws were for research only was significantly higher in the experimental arm (16% for C and 44% for E; p = 0.002). Providing a simple information chart may help alleviate this aspect of therapeutic misconception.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"44 2","pages":"18-25"},"PeriodicalIF":0.0,"publicationDate":"2022-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89923127","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: 1
Evaluating the Ability to Consent to Research: A Twenty-Year Track Record 评估同意研究的能力:二十年的记录
Ethics & human research Pub Date : 2022-02-26 DOI: 10.1002/eahr.500119
Mikaela Matera-Vatnick, Katherine W. Todman, Paul G. Wakim, Haley K. Sullivan, Carol Squires, Julie Brintnall-Karabelas, Samuel N. Doernberg, Marion Danis
{"title":"Evaluating the Ability to Consent to Research: A Twenty-Year Track Record","authors":"Mikaela Matera-Vatnick,&nbsp;Katherine W. Todman,&nbsp;Paul G. Wakim,&nbsp;Haley K. Sullivan,&nbsp;Carol Squires,&nbsp;Julie Brintnall-Karabelas,&nbsp;Samuel N. Doernberg,&nbsp;Marion Danis","doi":"10.1002/eahr.500119","DOIUrl":"10.1002/eahr.500119","url":null,"abstract":"<div>\u0000 \u0000 <p>Occasionally, the ability of prospective research participants to consent may be uncertain. Yet standardized capacity-assessment tools may not suffice to determine the ability to consent to a particular research protocol. This study consisted of a retrospective review of the outcomes of an alternative approach used by the Ability to Consent Assessment Team at the National Institutes of Health. Of 944 individuals evaluated over 20 years (1999-2019), 70.1% were determined to have capacity to consent to participate in research. Of those who lacked capacity to consent and were subsequently evaluated for their ability to assign a surrogate, 86.0% had the ability to do so. The findings demonstrate that establishing a task-specific approach for assessing the capacity of potential participants to consent to a variety of research protocols can facilitate safe and ethically justifiable inclusion of individuals whose ability to consent is initially uncertain.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"44 2","pages":"2-17"},"PeriodicalIF":0.0,"publicationDate":"2022-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80885574","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
Institutional Review Board Use of Outside Experts: What Do We Know? 机构审查委员会使用外部专家:我们知道什么?
Ethics & human research Pub Date : 2022-02-26 DOI: 10.1002/eahr.500121
Kimberley Serpico, Vasiliki Rahimzadeh, Emily E. Anderson, Luke Gelinas, Holly Fernandez Lynch
{"title":"Institutional Review Board Use of Outside Experts: What Do We Know?","authors":"Kimberley Serpico,&nbsp;Vasiliki Rahimzadeh,&nbsp;Emily E. Anderson,&nbsp;Luke Gelinas,&nbsp;Holly Fernandez Lynch","doi":"10.1002/eahr.500121","DOIUrl":"10.1002/eahr.500121","url":null,"abstract":"<div>\u0000 \u0000 <p>Institutional review boards (IRBs) are permitted by regulation to seek assistance from outside experts when reviewing research applications that are beyond the scope of expertise represented in their membership. There is insufficient understanding, however, of when, why, and how IRBs consult with outside experts, as this practice has not been the primary focus of any published literature or empirical study to date. These issues have important implications for IRB quality. The capacity IRBs have to fulfill their mission of protecting research participants without unduly hindering research is influenced by IRBs’ access to and use of the right type of expertise to review challenging research ethics, regulatory, and scientific issues. Through a review of the regulations and standards permitting IRBs to draw on the competencies of outside experts and through examination of the needs, strategies, challenges, and concerns related to doing so, we identify critical gaps in the existing literature and set forth an agenda for future empirical research.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"44 2","pages":"26-32"},"PeriodicalIF":0.0,"publicationDate":"2022-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9853442","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: 6
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