(52) Waiver of Informed Consent in Neonatal and Pediatric Randomized Controlled Trials

Background: Randomized controlled trials (RCTs) are essential to advancing neonatal care, but conducting them in emergent postnatal settings presents ethical and logistical challenges—particularly around informed consent. Antenatal consent is often impractical due to unpredictable delivery timing and maternal incapacity, leading to biased enrollment and limited generalizability. As a result, neonatal practice often relies on low-quality evidence. Alternative consent models including deferred, opt-out, and waiver of consent have been used to address these challenges. Waiver of consent is widely used in adult research but less commonly in pediatric and neonatal contexts.

Objectives: To examine how waiver of informed consent has been used in neonatal and pediatric RCTs and to explore associated ethical considerations.

Design/Methods: A comprehensive PubMed search using MeSH terms and keywords related to waiver of consent and pediatric/neonatal populations was conducted. Included studies were RCTs involving patients aged 0–17 years, where at least some participants were enrolled under a waiver of consent and the intervention directly affected patients. A total of 827 articles were screened by abstract or full text

Results: Nine eligible trials were identified, five neonatal and four pediatric. All involved interventions commonly used in clinical care and studied under conditions of clinical equipoise. Each occurred in settings where obtaining prior consent was impracticable, often due to the need for emergent treatment. Justifications for waiver included minimal risk, urgency, and concerns about selection bias with prospective consent. Parental notification strategies varied; some trials provided post-enrollment materials, while others lacked clear reporting.

Conclusions: Waiver of consent has been selectively used in pediatric and neonatal RCTs. When applied under strict ethical oversight, it may enable essential, pragmatic research in time-sensitive settings. However, its use should be limited and accompanied by proactive, ongoing dialogue among researchers, clinicians, and families to ensure ethical use and preservation of trust. Further evaluation of its impact on enrollment, equity, outcomes, and parental attitudes is essential to guide responsible implementation.