Ethics & human research最新文献_第6页

Disclosing Conflicts of Interest to Potential Research Participants: Good for Nothing? 向潜在的研究参与者披露利益冲突:无益?

Ethics & human research Pub Date : 2023-03-27 DOI: 10.1002/eahr.500157

Inmaculada de Melo-Martín

引用次数: 0

Research Ethics during Pandemics: How IRBs Can Prepare 流行病期间的研究伦理:内部审查委员会如何做好准备

Ethics & human research Pub Date : 2023-03-27 DOI: 10.1002/eahr.500159

Jacob M. Appel, Ilene Wilets

引用次数: 1

Remnant Blood Quantification: Informing the Definition of Minimal Risk in Clinical Research 残血定量:告知临床研究中最小风险的定义

Ethics & human research Pub Date : 2023-03-27 DOI: 10.1002/eahr.500160

Adam L. Gottula, Sara Constand, Sandra Cabrera, Uwe Stolz, Ann Salvator, Michael Goodman, Jason McMullan

{"title":"Remnant Blood Quantification: Informing the Definition of Minimal Risk in Clinical Research","authors":"Adam L. Gottula, Sara Constand, Sandra Cabrera, Uwe Stolz, Ann Salvator, Michael Goodman, Jason McMullan","doi":"10.1002/eahr.500160","DOIUrl":"10.1002/eahr.500160","url":null,"abstract":"<div>\u0000 \u0000 <p>Guidelines from the Office for Human Research Protections regarding categories of research that institutional review boards (IRBs) may review through expedited procedures limit the volume of blood that can be obtained from research participants for minimal risk research purposes. As defined by the Common Rule, minimal risk research is research in which the probability and magnitude of harm or discomfort anticipated are not greater than the probability and magnitude of harm or discomfort encountered from routine clinical tests. For this study, we considered the volume of remnant blood following routine clinical tests in light of the current definition of minimal risk in research. Conducted at a single institution, this was a prospective cross-sectional study that evaluated blood draws from 122 patients. The median daily remnant blood volume was 11.6 (interquartile range [IQR]: 12.3, 15.2) ml for all patients and 12.9 (IQR: 13.1, 16.9) ml for patients admitted to the intensive care unit. Our findings regarding daily remnant blood volume suggest that the currently allowable blood-volume limits to qualify for expedited review or to qualify as not more than minimal risk research involving blood draws from nonhealthy adults are less than what patients experience in routine medical testing. These findings support permitting an increase in the allowable blood-volume limits to meet the regulatory definition of minimal risk research for obtaining expedited IRB review of studies in which blood samples will be collected.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"45 2","pages":"35-39"},"PeriodicalIF":0.0,"publicationDate":"2023-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/eahr.500160","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9198168","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

Legally Effective but Ethically Inadequate: Institutional Review Board Policies for Consent from Legally Authorized Representatives 法律上有效，但道德上不充分:机构审查委员会的政策，从合法授权的代表同意

Ethics & human research Pub Date : 2023-03-27 DOI: 10.1002/eahr.500158

Robert R. Harrison

引用次数: 0

An Uncommonly Good Foundation for Research Ethics 一个不同寻常的良好研究伦理基础

Ethics & human research Pub Date : 2023-03-27 DOI: 10.1002/eahr.500161

Nancy M. P. King

引用次数: 0

Factors That Impact Hospital-Specific Enrollment Rates for a Neonatal Clinical Trial: An Analysis of the HEAL Study 影响新生儿临床试验医院特异性入组率的因素:对HEAL研究的分析

Ethics & human research Pub Date : 2023-01-23 DOI: 10.1002/eahr.500154

Katherine F. Guttmann, Sijia Li, Yvonne W. Wu, Sandra E. Juul, Benjamin S. Wilfond, Elliott Mark Weiss, HEAL Recruitment Collaborative

{"title":"Factors That Impact Hospital-Specific Enrollment Rates for a Neonatal Clinical Trial: An Analysis of the HEAL Study","authors":"Katherine F. Guttmann, Sijia Li, Yvonne W. Wu, Sandra E. Juul, Benjamin S. Wilfond, Elliott Mark Weiss, HEAL Recruitment Collaborative","doi":"10.1002/eahr.500154","DOIUrl":"10.1002/eahr.500154","url":null,"abstract":"<div>\u0000 \u0000 <p>Inconsistent enrollment among hospitals for neonatal clinical trials may lead to study populations that are not representative of the patient population in the neonatal intensive care unit. The High-Dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial was a multisite randomized clinical trial investigating erythropoietin as a neuroprotective treatment for term infants (those born between 37 and 42 complete weeks) with hypoxic ischemic encephalopathy. Substantial variability was noted in enrollment rate by hospital. We developed survey questions across five conceptual domains to understand systems-level issues that might contribute to variation in enrollment rate by hospital. Our study found that hospitals varied in their responses across these five domains. We propose three potential reasons that we found a lack of identifiable hospital-level factors that correlated with enrollment rates: sample-size limitations, methodological concerns, and confounding factors. Future studies with a larger sample size should be considered to evaluate contributors to hospital-level variability. This will lead to more robust recruitment strategies, improved enrollment, and decreases in the waste of research resources.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"45 1","pages":"29-38"},"PeriodicalIF":0.0,"publicationDate":"2023-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9969810/pdf/nihms-1875676.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9362631","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: 1

Can the Research Team-Participant Relationship Ground Ancillary-Care Obligations? 研究团队与参与者的关系能否构成辅助护理义务的基础?

Ethics & human research Pub Date : 2023-01-23 DOI: 10.1002/eahr.500152

Henry S. Richardson

{"title":"Can the Research Team-Participant Relationship Ground Ancillary-Care Obligations?","authors":"Henry S. Richardson","doi":"10.1002/eahr.500152","DOIUrl":"10.1002/eahr.500152","url":null,"abstract":"<div>\u0000 \u0000 <p>Discussion of medical researcher teams' ancillary-care obligations has long been dominated by partial-entrustment theory, developed in 2004 by the author of this article, in collaboration with Leah Belsky. Critics of the limited scope of the special ancillary-care obligations defended by that theory, however, argue that a better theory would take fuller account of the relationship that develops between individual research participants and members of the research team. Nate W. Olson and Thaddeus Metz have each put forward well worked-out versions of such a relationship-based account of ancillary-care obligations. This article critically evaluates these accounts, concluding that while each of them is vulnerable to various criticisms, each also crucially facilitates understanding of this relationship: Olson brings out well how research participants can find that role not just beneficial but also deeply meaningful, and Metz, drawing on African ethical traditions, emphasizes that when things go well, participants are involved as partners in the research effort. Yet the article closes by arguing that the partial-entrustment theory, surprisingly, can take on board each of these lessons. As so enhanced, it may actually be the best available relationship-based theory of this subject.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"45 1","pages":"2-14"},"PeriodicalIF":0.0,"publicationDate":"2023-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10618315","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

Public Policy Experiments without Equipoise: When Is Randomization Fair? 没有平衡的公共政策实验:什么时候随机化是公平的?

Ethics & human research Pub Date : 2023-01-23 DOI: 10.1002/eahr.500153

Douglas MacKay, Emma Cohn

引用次数: 0

Challenges and Possible Solutions to Adapting to Virtual Recruitment: Lessons Learned from a Survey Study during the Covid-19 Pandemic 适应虚拟招聘的挑战和可能的解决方案：新冠肺炎大流行期间调查研究的经验教训。

Ethics & human research Pub Date : 2022-10-31 DOI: 10.1002/eahr.500148

Krista E. Cooksey, Jessica Mozersky, James DuBois, Lindsay Kuroki, Christine M. Marx, Mary C. Politi

{"title":"Challenges and Possible Solutions to Adapting to Virtual Recruitment: Lessons Learned from a Survey Study during the Covid-19 Pandemic","authors":"Krista E. Cooksey, Jessica Mozersky, James DuBois, Lindsay Kuroki, Christine M. Marx, Mary C. Politi","doi":"10.1002/eahr.500148","DOIUrl":"10.1002/eahr.500148","url":null,"abstract":"<div>\u0000 \u0000 <p>The Covid-19 pandemic required rapid changes to research protocols, including immediate transitions to recruiting research participants and conducting the informed consent process virtually. This case study details the challenges our research team faced adapting an in-person, behavioral-intervention and survey study to virtual recruitment. We reflect on the impact of these rapid changes on recruitment and retention, discuss protocol changes we made to address these challenges and the needs of potential and enrolled participants, and propose recommendations for future work. Using computer technology to display professional return phone numbers, being flexible by contacting potential participants through various means, minimizing email communication due to added regulatory requirements, and partnering with the institutional review board to shorten and improve the consent document and process were critical to study success. This case study can offer insight to other researchers as they navigate similar processes. Virtual recruitment is likely to continue; it is important to ensure that it facilitates, rather than hinders, equitable and just recruitment practices.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"44 6","pages":"23-31"},"PeriodicalIF":0.0,"publicationDate":"2022-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9631333/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40437094","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: 3

Demonstration Project: Transitioning a Research Network to New Single IRB Platforms 示范项目：将研究网络过渡到新的单一IRB平台。

Ethics & human research Pub Date : 2022-10-31 DOI: 10.1002/eahr.500149

Jeri S. Burr, Ann Johnson, Annie Risenmay, Stephanie Bisping, Emily S. Serdoz, Whit Coleman, Katherine A. Sward, Erin Rothwell, J. Michael Dean

{"title":"Demonstration Project: Transitioning a Research Network to New Single IRB Platforms","authors":"Jeri S. Burr, Ann Johnson, Annie Risenmay, Stephanie Bisping, Emily S. Serdoz, Whit Coleman, Katherine A. Sward, Erin Rothwell, J. Michael Dean","doi":"10.1002/eahr.500149","DOIUrl":"10.1002/eahr.500149","url":null,"abstract":"<div>\u0000 \u0000 <p>Since the 2016 National Institutes of Health (NIH) mandate to use a single IRB (sIRB) in multicenter research, institutions have struggled to operationalize the process. In this demonstration project, the University of Utah Trial Innovation Center assisted the Collaborative Pediatric Critical Care Research Network to transition from using individually negotiated reliance agreements and paper-based documentation to a new sIRB master agreement and an informatics platform to capture reliance documentation. Lessons learned that can guide other academic institutions and IRBs as they operationalize sIRBs included the need for sites to understand what type of engagement or reliance is required and their need to understand the difference between reliance and activation. Requirements around local review remain poorly understood. Further research is needed to determine approaches that can achieve the NIH vision of reviews becoming more efficient and improving study start-up times, relieving administrative burden while advancing human research protections.</p>\u0000 </div>","PeriodicalId":36829,"journal":{"name":"Ethics & human research","volume":"44 6","pages":"32-38"},"PeriodicalIF":0.0,"publicationDate":"2022-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10328109/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9929114","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: 2