The Use of Waivers of Guardian Permission in the United States for Pediatric Digital Health Intervention Research Since 2020: Systematic Review - Report - MDSpire
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Examining Guardian Permission Waivers for Pediatric Digital Health Research in the U.S. Since 2020: A Systematic Review

  • By

  • Colleen Stiles-Shields

  • Elyse Shenberger

  • Ann Bernica

  • Gabriella Bobadilla

  • Kandis Fletcher

  • Jasmine George

  • Sydney Gordon

  • Erika L Gustafson

  • Crystal S Hernandez

  • Taylor L Hilderbrand

  • Sarah N Kumi

  • Christine A Lee

  • Sarah I Lorduy

  • Meera Phanse

  • Lauren M Potthoff

  • Naomi Quezada

  • Dale L Smith

  • Holly J Hudson

  • Emily E Anderson

  • September 25, 2026

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Clinical Report: Guardian Permission Waivers for Pediatric Digital Health Research

Overview

This systematic review examines guardian permission waivers in pediatric digital health research in the U.S. since 2020, highlighting barriers faced by adolescents in participating in research due to the requirement of guardian consent, particularly in sensitive areas such as mental health.

Background

The mental health crisis among youth in the U.S. is exacerbated by provider shortages and access issues. Digital health interventions have emerged as a potential solution to these barriers, yet participation in research often requires guardian consent, which can limit access for certain adolescents.

Data Highlights

No numerical data or trial data was provided in the source material.

Key Findings

  • Guardian permission is generally required for minors to participate in research in the U.S.
  • Obtaining guardian consent may deter adolescents from participating in studies on sensitive topics.
  • Some states allow minors aged 12 and older to seek mental health treatment without guardian consent, but this does not consistently apply to research.
  • Exclusion of certain youth from research can skew findings and limit the applicability of results.
  • Digital health interventions could provide scalable solutions to address mental health issues among youth.

Clinical Implications

Healthcare professionals should be aware of the barriers that guardian consent requirements create for adolescent participation in research.

Conclusion

The review discusses the implications of guardian consent requirements in pediatric research.

Related Resources & Content

  1. Merikangas KR, He JP, Burstein M, et al., J Am Acad Child Adolesc Psychiatry, 2011 -- Service utilization for lifetime mental disorders in U.S. adolescents
  2. Murthy VH, US Department of Health and Human Services, 2021 -- Protecting youth mental health: the US Surgeon General’s Advisory
  3. Whitney DG, Peterson MD, JAMA Pediatr, 2019 -- US national and state-level prevalence of mental health disorders and disparities of mental health care use in children
  4. MDSpire News — Portal Privacy Study Shows Age Group Trends
  5. Journal of Medical Internet Research (JMIR) — Pediatric Clinical Images Without Consent: A Governance Gap in the Long-Term Reuse of Health Data in Digital Health Ecosystems
  6. ASCO Publications — Parental Knowledge and Decisional Satisfaction Across Genomic Sequencing Consent Processes in Pediatric Cancer
  7. npj Digital Medicine — Toward governance of artificial intelligence in pediatric healthcare
  8. Research with Children FAQs | HHS.gov
  9. Federal Register / Vol. 89, No. 206 / Thursday, October 24, 2024 / Rules and Regulations
  10. Principles for Health Information Technology to Support and Protect Adolescent Confidentiality
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  12. Additional Protections for Children | FDA
  13. Confidentiality in the Care of Adolescents: Policy Statement | Pediatrics | American Academy of Pediatrics
  14. Confidentiality in the Care of Adolescents: Technical Report | Pediatrics | American Academy of Pediatrics
  15. Can a minor child’s doctor talk to the child’s parent about the patient’s mental health status and needs? | HHS.gov
  16. Children’s Online Privacy Protection Rule | Federal Trade Commission
  17. Successful Digital Recruitment of Adolescents for Population-Based Research: A Case Study of Methods and Strategies - ScienceDirect
  18. Screening and Retaining Adolescents Recruited Through Social Media: Secondary Analysis from a Longitudinal Clinical Trial - PMC
  19. Online randomised trials with children: A scoping review | PLOS One
  20. Guidelines on the Inclusion and Protection of Adolescent Minors and Young Adults in Health Research: A Position Statement of the Society for Adolescent Health and Medicine.

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