Partial waiver of consent to overcome translational science barriers in neonatal clinical research

Abstract

Prospective consent in neonatal research poses significant challenges, particularly during urgent, time-sensitive clinical windows of study enrollment. This is especially true at referral centers for large geographic regions. A partial waiver of consent offers a potential translational science approach to enhance access to research participation in critically ill neonates. We compared enrollment rates in a study evaluating pulse oximetry accuracy across neonates with varying skin pigmentation before and after implementing a partial waiver of consent. Overall enrollment increased significantly without creating a racial disparity in enrollment, thereby improving generalizability and efficiency in neonatal clinical research.

Keywords: Neonates; clinical trials; consent; enrollment; equity.

Figure 1.

Implementing partial waiver of consent was associated with improved enrollment among neonates born to non-Hispanic White and non-Hispanic Black mothers. The figure shows estimated enrollment percentages by race and phase (Pre–Partial waiver [Pre-PW] vs. Partial waiver [PW]), derived from a logistic regression model with an interaction term. Error bars represent 95% confidence intervals. P-values reflect pairwise comparisons of model-estimated proportions. Neither the between-race comparisons within each phase nor the interaction term (p = 0.886) was statistically significant.