A5020073649- Ethics in Clinical Research
- Ethics in medical practice
- Health and Medical Research Impacts
- Meta-analysis and systematic reviews
- Biomedical Ethics and Regulation
- Biomedical and Engineering Education
- Discourse Analysis and Cultural Communication
- Genomics and Rare Diseases
- Collaborative Teaching and Inclusion
- Interdisciplinary Research and Collaboration
- Public Health Policies and Education
- Cancer Genomics and Diagnostics
- Disaster Response and Management
- Healthcare Policy and Management
- Communication in Education and Healthcare
- Bacillus and Francisella bacterial research
- Science Education and Pedagogy
- Childhood Cancer Survivors' Quality of Life
- Healthcare cost, quality, practices
- Innovations in Medical Education
- Rhetoric and Communication Studies
- Child and Animal Learning Development
- Health Sciences Research and Education
- Defense, Military, and Policy Studies
- Language, Discourse, Communication Strategies
University of Utah
1994-2024
Multicenter clinical trials play a critical role in the translational processes that enable new treatments to reach all people and improve public health. However, conducting multicenter randomized (mRCT) presents challenges. The Trial Innovation Network (TIN), established 2016 partner with Clinical Translational Science Award (CTSA) Consortium of academic medical institutions implementation mRCTs, consists 3 Centers (TICs) 1 Recruitment Center (RIC). This unique partnership has aimed address...
The COVID-19 pandemic changed the clinical research landscape in America. most urgent challenge has been to rapidly review protocols submitted by investigators that were designed learn more about or intervene COVID-19. International Review Board (IRB) offices developed plans related pandemic. An online survey was conducted with IRB Directors at Clinical and Translational Science Awards (CTSA) institutions as well two focus groups. Across CTSA institutions, 66% reviewed across all their...
Abstract The Trial Innovation Network has established an infrastructure for single IRB review in response to federal policies. Network’s (sIRBs) have successfully supported over 70 multisite studies via more than 800 reliance arrangements. This generated several lessons learned that can benefit the national clinical research enterprise, as we work improve conduct of trials. These include distinguishing roles from institutional Human Research Protections programs, establishing a consistent...
Implementing the National Institutes of Health's (NIH's) new single institutional review board (IRB) policy has caused a paradigm shift in IRB across country. IRBs and human research protection programs are looking more closely at their processes for ceding developing procedures to handle local when relying on IRB. This article describes an NIH-funded network that proactively instituted central (CIRB) 2012, anticipating NIH future mandate. Lessons learned described. There was steep learning...
The past few years have witnessed a heightened awareness of gender issues in NDT debate. There are wide variety which come to the surface recently and it is important that we extend discussion debate on multiplicity concerns order comprehend subject more fully. particular issue this paper will address possibility females males their performances evaluated differently. In may be difficult identify an overall pattern results can called sex bias. It distinguish between lack success due...
Research is foundational for evidence-based management of patients. Clinical research, however, takes time to plan, conduct, and disseminate-a luxury that rarely available during a public health emergency. The University Nebraska Medical Center (UNMC) developed single institutional review board (IRB), with vision establish rapid resource network focused on clinical research emerging pathogens in the United States. A core aspect successful initiation pandemic or epidemic ability...
There is growing interest for research ethics professionals to engage with members of the public, yet they often lack training needed effectively. The STEM Ambassador Program provides a promising framework form authentic community connections and carry out effective engagement activities based on shared interests values. experiences ten administrators who participated in pilot are presented. Post-training surveys indicate that valued skills obtained, intend continue public support their leadership.
The primary purpose of Institutional Review Boards (IRBs) is to protect the rights and welfare human research participants. Evaluation measurement how IRBs satisfy this other important goals are open questions that demand empirical research. Research on IRBs, Human Protection Programs (HRPPs) which they often a part, necessary inform evidence-based practices, policies, approaches quality improvement in protections. However, date, HRPP IRB engagement about their own activities performance has...
Abstract Background Community consultation activities are required by the Food and Drug Administration prior to conducting research using exception from informed consent (EFIC) for emergency aim provide additional participant protections. However, it is difficult institutional review boards (IRBs) assess efficacy of such activities. In this study, our primary was evaluate PediDOSE trial's answering key questions about whether efforts reached a relevant community if perspectives consulted...
Abstract Rapid whole genome sequencing (rapid WGS) is a powerful diagnostic tool that becoming increasingly practical for widespread clinical use. However, protocols its use are challenging to implement. A significant obstacle adoption laboratory certification requires an initial research development phase, which constrained by regulations from returning results. Regulations preventing return of results have ethical implications in cases might impact patient outcomes. Here, we describe our...
In the context of emergency research, researchers can ask institutional review board (IRB) to waive regulatory requirement that individuals provide informed consent when enrolling in research studies. A waiver is reviewing IRB must and approve a community consultation public disclosure plan. It critical an serving as single (sIRB) for multisite be thoroughly versed local concerns each participating site determine whether site's being adequately consulted about which will enrolled under...
Single IRB (SIRB) consultation resources were established by the Utah Trial Innovation Center to assist and educate investigative teams prior submission of funding applications for multisite, cooperative research. Qualitative analysis written materials meeting minutes revealed most common areas education needed teams, including (a) differences relationships between a Human Research Protection Program (HRPP); (b) main phases SIRB process; (c) use technology platforms documentation review...
ABSTRACT Since the 2016 National Institutes of Health (NIH) mandate to use a single IRB (sIRB) in multicenter research, institutions have struggled operationalize process. In this demonstration project, University Utah Trial Innovation Center assisted Collaborative Pediatric Critical Care Research Network transition from using individually negotiated reliance agreements and paper‐based documentation new sIRB master agreement an informatics platform capture documentation. Lessons learned that...
The purpose of this article is to provide the speech-language pathologist with information regarding assessment pragmatic skills in children's language. authors delineate most frequently occurring problems functions Necessary considerations involved taking a language sample that will allow analysis parameters given, and an dialogue included.
In February 2023, the U.S. Government Accountability Office (GAO) released another report acknowledging that we still lack meaningful, validated, widely-accepted measures for evaluating institutional review board (IRB) quality and effectiveness. This challenge is well known to Consortium Advance Effective Research Ethics Oversight (www.AEREO.org), a collaborative group of human research protection (HRP) professionals, researchers, ethicists founded in 2018 do precisely what GAO recommends:...
This article examines a competency-based objectives system for evaluating the student teaching experience. It is composed of 89 competencies which cover broad range knowledge, skill, and value that likely to experienced during teaching. The form was field-tested using 34 teachers 30 supervising clinicians. Data were collected comparing traditional numerical rating form.