Ethical Challenges with the Informed Consent Process in Pediatric Research Studies.

Background: Informed Consent (IC) is crucial in pediatric research, aligning with the National Research Act of 1974 and the Belmont Report's principles. Current regulations, particularly 45 CFR 46, provide additional safeguards for children in research.

Objective: This article explores ethical challenges in pediatric research IC, drawing from PubMed literature and regulatory guidelines to understand historical context, legislative milestones, and contemporary issues.

Methods: A literature review, primarily sourced from PubMed, informed the examination of pediatric research and IC, referencing guidelines from the American Academy of Pediatrics and regulations from the FDA and HHS.

Results: The study underscores the need for increased pediatric research due to the prevalence of drugs studied on adults. Despite legislative efforts like the FDAMA and Pediatric Research Equity Act, ethical challenges persist in obtaining IC in pediatric studies.

Conclusion: Pediatric research necessitates nuanced IC approaches, involving parents, guardians, and children. Ethical challenges such as coercion and compensation require attention, with recommendations emphasizing guideline adherence and increased public engagement for trust-building and pediatric health advancement.