While digital health interventions (DHIs) offer scalable pathways to support youth mental and behavioral health, traditional regulatory requirements for parental or guardian permission can unintentionally hinder research access. For adolescents seeking guidance on sensitive topics such as sexual health, gender identity, or substance use, requiring guardian disclosure can create safety concerns, deter participation, and skew trial samples.
Key Takeaways |
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Privacy as Primary Justification: Participant privacy, specifically avoiding forced disclosure of stigmatized behaviors or sexual and gender identities to unsupportive guardians, was the most frequent rationale for obtaining a permission waiver. |
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Inclusive Gender Reporting and Online Recruitment: Trials operating with a waiver were over four times more likely to assess gender beyond the binary (odds ratio 4.27) and were significantly more likely to recruit national cohorts online rather than through in-person clinics. |
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Follow-Up Retention Differences: Studies utilizing permission waivers reported lower follow-up retention (77.0%) compared to studies requiring guardian permission (88.6%), likely reflecting remote, digital recruitment dynamics rather than intervention engagement itself. |
In a systematic review published in the Journal of Medical Internet Research, lead researcher Colleen Stiles-Shields and colleagues at the Institute for Juvenile Research, University of Illinois Chicago evaluated 49 randomized controlled trials of pediatric DHIs conducted across the United States between 2020 and 2026 to assess the rationales, methodological characteristics, and retention outcomes associated with waivers of guardian permission.
How can researchers and Institutional Review Boards (IRBs) balance child protection with adolescent autonomy in online interventions? The review revealed no significant differences in risk levels, sensitive topics, or participant demographics between studies that obtained permission waivers and those that did not.
This lack of systematic variation suggests that IRBs across the United States interpret federal guidance on minimal risk and practicability inconsistently. Developing clearer evidence-based standards will be essential to ensure pediatric digital health studies protect participant rights while ensuring marginalized youth are not excluded from life-saving interventions.
Discover how informed consent and guardian waiver practices impact pediatric digital health trials:
Read the Full Open-Access Systematic Review to explore the complete PRISMA analysis, Cochrane risk-of-bias assessments, and regression models.
Watch the Author Video to hear Colleen Stiles-Shields discuss guardian permission waivers and ethical frameworks in pediatric digital health research.
| In this video, Colleen Stiles-Shields from the Institute for Juvenile Research at the University of Illinois Chicago discusses a systematic review analyzing the use of guardian permission waivers in randomized controlled trials of pediatric digital health interventions (DHIs) across the United States. |
"There were very few differences between studies that required guardian permission and those that didn't. This is likely telling us that IRBs across the country are interpreting guidelines quite differently, which highlights an urgent need for clearer, standardized ethical frameworks in digital health research with youth."
— Colleen Stiles-Shields, PhD (Institute for Juvenile Research, University of Illinois Chicago)
Stiles-Shields C, Shenberger E, Bernica A, Bobadilla G, Fletcher K, George J, Gordon S, Gustafson E, Hernandez C, Hilderbrand T, Kumi S, Lee C, Lorduy S, Phanse M, Potthoff L, Quezada N, Smith D, Hudson H, Anderson E
The Use of Waivers of Guardian Permission in the United States for Pediatric Digital Health Intervention Research Since 2020: Systematic Review
J Med Internet Res 2026;28:e87047
URL: https://www.jmir.org/2026/1/e87047
DOI: 10.2196/87047