A5004447374- Ethics and Legal Issues in Pediatric Healthcare
- Ethics in medical practice
- Ethics in Clinical Research
- Palliative Care and End-of-Life Issues
- Emergency and Acute Care Studies
- Trauma and Emergency Care Studies
- Adolescent and Pediatric Healthcare
- Childhood Cancer Survivors' Quality of Life
- Healthcare Policy and Management
- Health and Medical Research Impacts
- Abdominal Trauma and Injuries
- Health Sciences Research and Education
- Innovations in Medical Education
- Healthcare Decision-Making and Restraints
University of Utah
2013-2024
Research Network (United States)
2014
Federal regulations allow exception from informed consent (EFIC) to study emergent conditions when obtaining prospective is not feasible. Little known about public views on including children in EFIC studies. The Pediatric Dose Optimization for Seizures EMS (PediDOSE) trial implements age-based, standardized midazolam dosing pediatric seizures. primary objective of this was determine support and concerns the PediDOSE trial. secondary assess how varied by demographics.
BACKGROUND With increasing attention to the quality of health care delivery, evaluating trauma triage decisions in a large system emergency can help decision makers reduce mortality, morbidity, unnecessary transfers, and costs. OBJECTIVES To quantify magnitude pediatric traumatic injury undertriage (hospital mortality risk) overtriage (early center discharge after transfer) statewide system. METHODS A population-based evaluation outcomes secondary (interfacility transfers) patterns from 2001...
Background: The US federal regulation “Exception from Informed Consent for Emergency Research,” 21 Code of Federal Regulations 50.24, permits emergency research without informed consent under limited conditions. Additional safeguards to protect human subjects include requirements community consultation and public disclosure prior starting the research. Because regulations are vague about these requirements, Institutional Review Boards determine adequacy activities at a local level. Thus,...
Duty hour restrictions limit the use of resident physicians in pediatric emergency departments (PEDs). We sought to determine relative clinical productivity PED attending working with residents compared nurse practitioners (NPs).In a tertiary care multiple models (PED and/or fellows, NPs, alone), we identified periods when was provided concurrently and exclusively by physician 1 2 (resident pod) NP (NP pod). Billing records were reviewed value units (RVUs) generated patients seen each...
Abstract Background Supporting clinical research is a national priority. Clinician scientists are rare and trials in academic medical centers (AMC) often fail to meet enrollment goals. Undergraduate students interested biomedical careers lack opportunities perform research. Objective Describe an innovative undergraduate course that supports AMC. Methods The course, Clinical Research Practice, offers the opportunity learn through didactic practical experiences. turn support clinician...
Background: In the United States, enrollment in clinical trials that involve emergency care may require compliance with federal regulations for Exception from Informed Consent (EFIC), including Community Consultation and Public Disclosure (CCPD). The most effective methods CCPD studies of children are not known. Aim: To describe results a centralized media-based outreach effort Pediatric Prehospital Airway Resuscitation Trial (Pedi-PART), multicenter trial testing paramedic airway management...
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...
Acquiring parental consent is critical to pediatric clinical research, especially in interventional trials. In this study we investigated demographic, clinical, and environmental factors associated with likelihood of permission for enrollment a therapies diabetic ketoacidosis (DKA) children.We analyzed data from patients parents who were approached the Pediatric Emergency Care Applied Research Network (PECARN) Fluid Therapies Under Investigation DKA (FLUID) trial at one major participating...
Introduction: Acquiring parental consent is critical to pediatric clinical research, especially in interventional trials. In this study we investigated demographic, clinical, and environmental factors associated with likelihood of permission for enrollment a therapies diabetic ketoacidosis (DKA) children. Methods: We analyzed data from patients parents who were approached the Pediatric Emergency Care Applied Research Network (PECARN) Fluid Therapies Under Investigation DKA (FLUID) trial at...