Informed consent procedures for emergency interventional research in patients with traumatic brain injury and ischaemic stroke
EJO Kompanje, JTJM van Dijck, V Chalos… - The Lancet …, 2020 - thelancet.com
Health-care professionals and researchers have a legal and ethical responsibility to inform
patients before carrying out diagnostic tests or treatment interventions as part of a clinical …
patients before carrying out diagnostic tests or treatment interventions as part of a clinical …
Meeting unique requirements: Community consultation and public disclosure for research in emergency setting using exception from informed consent
NW Dickert, K Metz, MD Fetters… - Academic …, 2021 - Wiley Online Library
Background Exception from informed consent (EFIC) regulations for research in emergency
settings contain unique requirements for community consultation and public disclosure …
settings contain unique requirements for community consultation and public disclosure …
PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial
SL Weiss, F Balamuth, E Long, GC Thompson… - Trials, 2021 - Springer
Background/aims Despite evidence that preferential use of balanced/buffered fluids may
improve outcomes compared with chloride-rich 0.9% saline, saline remains the most …
improve outcomes compared with chloride-rich 0.9% saline, saline remains the most …
Interactive media-based approach for an exception from informed consent trial involving patients with trauma
SW Stephens, C Carroll-Ledbetter, S Duckert… - JAMA …, 2024 - jamanetwork.com
Importance Exception From Informed Consent (EFIC) research requires community
consultation (CC) and public disclosure (PD). Traditional methods of conducting CC and PD …
consultation (CC) and public disclosure (PD). Traditional methods of conducting CC and PD …
Pilot randomized trial of pre-hospital advanced therapies for the control of hemorrhage (PATCH) using pelvic binders
SN Pierrie, RB Seymour, MK Wally, J Studnek… - The American journal of …, 2021 - Elsevier
Background Pelvic fractures represent a small percent of all skeletal injuries but are
associated with significant morbidity and mortality secondary to hemodynamic instability …
associated with significant morbidity and mortality secondary to hemodynamic instability …
Damage control laparotomy in trauma: a pilot randomized controlled trial. The DCL trial
JA Harvin, SD Adams, SJM Dodwad… - Trauma Surgery & …, 2021 - tsaco.bmj.com
Background Although widely used in treating severe abdominal trauma, damage control
laparotomy (DCL) has not been assessed in any randomized controlled trial. We conducted …
laparotomy (DCL) has not been assessed in any randomized controlled trial. We conducted …
Patient and surrogate attitudes via an interviewer-administered survey on exception from informed consent enrollment in the Prehospital Air Medical Plasma (PAMPer) …
Objectives With increased focus on early resuscitation methods following injury to improve
patient outcomes, studies are employing exception from informed consent (EFIC) …
patient outcomes, studies are employing exception from informed consent (EFIC) …
Multicenter social media community consultation for an exception from informed consent trial of the XStat device (PhoXstat trial)
SW Stephens, P Farley, SP Collins… - Journal of Trauma …, 2022 - journals.lww.com
METHODS Multicenter CC was administered by the lead site and conducted in preparation
for a three-site prehospital randomized clinical trial. We used Facebook and Instagram …
for a three-site prehospital randomized clinical trial. We used Facebook and Instagram …
Interactive media-based community consultation for exception from informed consent trials: How representative should (and can) it be?
JO Jansen, SW Stephens, B Crowley… - Journal of Trauma …, 2022 - journals.lww.com
Research in emergency care has been facilitated by an exception from the requirements for
obtaining and documenting informed consent. This exception only applies to a strictly limited …
obtaining and documenting informed consent. This exception only applies to a strictly limited …
Integration of social media with targeted emails and in‐person outreach for exception from informed consent community consultation
CH Hsu, J Fowler, JA Cranford… - Academic …, 2022 - Wiley Online Library
Background Exception from informed consent (EFIC) enables the enrollment of research
subjects with emergent conditions to clinical trials without prior consent. EFIC study approval …
subjects with emergent conditions to clinical trials without prior consent. EFIC study approval …