Research Consenting Practices in Critically Ill Children: A Scoping Review

Clinical trials are critical for advancing care in critically ill children, yet enrollment remains challenging because of surrogate decision-making, narrow recruitment windows, and caregiver stress. To evaluate strategies aimed at improving enrollment, particularly around consent, in clinical trials involving critically ill children, we conducted a scoping review of literature through December 2024. Studies involving children aged less than 18 years in critical care settings that described factors targeting consent were included. Nonhuman, hypothetical, and non-health care setting studies were excluded. Two reviewers independently screened studies, resolving conflicts through discussion. Of 2770 studies screened, 26 met the inclusion criteria. Study designs varied and included randomized controlled trials, observational studies, and qualitative research. The populations targeted included neonatal (12), pediatric (12), cardiac (1), and mixed critical care units (1). Six themes emerged as barriers to consent: family/social dynamics, emotional/psychological stress, limited understanding of clinical trials, logistical issues, clinical concerns, and study design. Facilitators included parental preferences, communication approaches, increased awareness, family motivation, and recruitment strategies. Alternative consent models, such as deferred consent, and multicenter designs were associated with improved enrollment. Co-enrollment and telesimulation had limited impact. Although few studies have directly focused on improving consent, strategies shown to enhance overall enrollment should be incorporated into future pediatric critical care trials.