The Use of Waivers of Guardian Permission in the United States for Pediatric Digital Health Intervention Research Since 2020: Systematic Review.
Colleen Stiles-Shields, Elyse Shenberger, Ann Bernica et al.
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In 30 seconds
This systematic review examined the use of guardian permission waivers in pediatric digital health intervention research in the U.S. from 2020 to 2026. Out of 49 included randomized controlled trials, 21 utilized waivers. Studies with waivers showed significantly lower follow-up retention (mean 77.03% vs 88.61%; P =.005) compared to those requiring permission.
Key findings
- Studies using waivers were more likely to assess gender beyond the binary (OR 4.27; P =.02).
- Waivers were associated with online recruitment (OR 0.04; P <.001).
- Follow-up retention was significantly lower in studies with waivers (mean 77.03% vs 88.61%; P =.005).
Why it matters
Understanding the implications of guardian permission waivers is crucial for conducting ethical pediatric research. This review highlights the need for clearer guidelines to balance participant protection with the advancement of digital health interventions.
What to keep in mind
The review's findings are limited by small sample sizes and variable reporting practices, which may affect statistical power.