Community perspectives on Exception from Informed Consent (EFIC) in the intensive care unit (ICU) setting: a mixed methods study

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.

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.

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.

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.