Community perspectives on Exception from Informed Consent (EFIC) in the intensive care unit (ICU) setting: a mixed methods study.
7 affiliations
- 1Department of Cardiology, Division of Cardiovascular Critical Care, Boston Children's Hospital, Boston, Massachusetts, USA.
- 2Department of Pediatrics, Harvard Medical School, Boston, Massachusetts, USA.
- 3Division of Pediatric Critical Care, Primary Children's Hospital, Salt Lake City, Utah, USA.
- 4Department of Pediatrics, University of Utah, Salt Lake City, Utah, USA.
- 5Department of Pediatrics, George Washington University, Washington, District of Columbia, USA.
- 6Division of Cardiac Critical Care, Children's National Hospital, Washington, District of Columbia, USA.
- 7Department of Pediatrics, Division of Medical Critical Care, Boston Children's Hospital, Boston, MA, USA.
Abstract
Introduction
The U.S. Exception from Informed Consent (EFIC) regulatory pathway enables clinical research in life-threatening situations where delays may preclude trial participation or reduce treatment efficacy. The use of EFIC in the intensive care unit (ICU) setting remains limited.Methods
In preparation for a prospective, multi-centre, ICU-based randomised controlled interventional trial, community consultations and public disclosures were conducted at three quaternary paediatric centres to assess the acceptability of an EFIC framework among community members and clinical staff. Session content was standardised, meetings were recorded and transcribed, and surveys with seven-point Likert scales (0-6) were distributed, with scores ≥5 considered affirmative.Results
We conducted 18 clinician meetings (cumulative attendance n=313) and 26 community meetings (cumulative attendance n=43). Survey responses (n=128) demonstrated strong EFIC support: 100% (24/24) community participants viewed the trial as important; 88% (49/56) of clinicians viewed reperfusion injury as clinically important. Also, 100% (24/24) community members and 93% (97/104) clinicians reported willingness to enrol a relative or patient. In the qualitative analysis, significant concerns about the feasibility, utility, and messaging of the pre-enrolment opportunities to object (OTO) led to it being left to enrolling clinicians' discretion. The post-enrolment OTO to ongoing participation process was considered appropriate.Conclusions
In this mixed methods study, community members and clinicians across three centres expressed support for use of EFIC in this ICU-based trial. These findings highlight the importance of structured and multi-perspective community engagement in EFIC trials and support its future use in the ICU setting.
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BibTeX
@article{keijer2026community,
title = {{Community perspectives on Exception from Informed Consent (EFIC) in the intensive care unit (ICU) setting: a mixed methods study.}},
author = {Bonne L Keijer and Krislyn M Boggs and Victoria Habet and Stephanie Goldstein and Christina Mamolea and Bao N Puente and Alix Fetch and Lynn A Sleeper and Catherine E Ross and John N Kheir},
journal = {BMJ public health},
year = {2026},
month = oct,
doi = {10.1136/bmjph-2026-005531},
url = {https://europepmc.org/article/MED/42974384},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Community perspectives on Exception from Informed Consent (EFIC) in the intensive care unit (ICU) setting: a mixed methods study.
AU - Bonne L Keijer
AU - Krislyn M Boggs
AU - Victoria Habet
AU - Stephanie Goldstein
AU - Christina Mamolea
AU - Bao N Puente
AU - Alix Fetch
AU - Lynn A Sleeper
AU - Catherine E Ross
AU - John N Kheir
PY - 2026
DA - 2026/10/28
JO - BMJ public health
DO - 10.1136/bmjph-2026-005531
UR - https://europepmc.org/article/MED/42974384
AB - Introduction The U.S. Exception from Informed Consent (EFIC) regulatory pathway enables clinical research in life-threatening situations where delays may preclude trial participation or reduce treatment efficacy. The use of EFIC in the intensive care unit (ICU) setting remains limited.Methods In preparation for a prospective, multi-centre, ICU-based randomised controlled interventional trial, community consultations and public disclosures were conducted at three quaternary paediatric centres to assess the acceptability of an EFIC framework among community members and clinical staff. Session content was standardised, meetings were recorded and transcribed, and surveys with seven-point Likert scales (0-6) were distributed, with scores ≥5 considered affirmative.Results We conducted 18 clinician meetings (cumulative attendance n=313) and 26 community meetings (cumulative attendance n=43). Survey responses (n=128) demonstrated strong EFIC support: 100% (24/24) community participants viewed the trial as important; 88% (49/56) of clinicians viewed reperfusion injury as clinically important. Also, 100% (24/24) community members and 93% (97/104) clinicians reported willingness to enrol a relative or patient. In the qualitative analysis, significant concerns about the feasibility, utility, and messaging of the pre-enrolment opportunities to object (OTO) led to it being left to enrolling clinicians' discretion. The post-enrolment OTO to ongoing participation process was considered appropriate.Conclusions In this mixed methods study, community members and clinicians across three centres expressed support for use of EFIC in this ICU-based trial. These findings highlight the importance of structured and multi-perspective community engagement in EFIC trials and support its future use in the ICU setting.
SN - 2753-4294
ER -