Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Nov 5, 2025
Date Accepted: Aug 12, 2026
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
The Use of Waivers of Guardian Consent in the United States for Pediatric Digital Health Intervention Research Since 2020: Systematic Review
ABSTRACT
Background:
Digital health interventions (DHIs) offer scalable ways to reach youth. Although DHI research often poses minimal risk, guardian consent is typically required, which can hinder participation. This requirement may unintentionally obstruct safe, high-quality research and delay its translation.
Objective:
To explore practices related to guardian consent, this study systematically reviewed randomized controlled trials (RCTs) of DHIs with U.S. minors published since March 2020.
Methods:
PubMed, EMBASE, PsycINFO, Cochrane Library, and Web of Science were searched for U.S.-based RCTs evaluating DHIs for pediatric mental/behavioral health that were written in English and peer-reviewed. Studies were excluded if randomized at the school level, included caregivers as participants, or had a mean age over 18. Two coders independently screened and extracted data, with a third resolving discrepancies. A narrative framework was used to identify themes. Meta- and logistic regressions were conducted to compare studies with and without consent waivers.
Results:
Of 2,073 screened studies, 35 met inclusion criteria (15 used guardian consent waivers; 20 required consent). The most commonly reported rationale for waiver use was participant privacy. Logistic regressions showed studies with waivers were more likely to assess gender beyond the binary (OR 4.68; P=.036) and more likely to recruit online (OR 0.04; P=.001). Meta-regression revealed significantly lower follow-up retention in studies with waivers (mean 77.03%) compared to those requiring guardian consent (mean 88.6%; P=.027). No significant differences emerged across age, race/ethnicity, suicidality, intervention focus, or retention.
Conclusions:
Although small sample sizes and variable reporting practices limited power, the lack of differences in sample characteristics or study features between studies that used waivers and those that did not suggests that Institutional Review Boards (IRBs) may be differentially interpreting regulations and guidance on waiving guardian consent. These findings likely indicate the need for more evidence to guide risk/benefit evaluation - or more education about existing evidence and the risks and potential benefits of DHI research. Clinical Trial: N/A
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