128 - Defining challenges in obtaining research consent in a level IV NICU

Publication Number: 3122.128

Martha Liu, Weill Cornell Medical College, New York, NY, United States; Melanie Gao, Weill Cornell Medicine, New York, NY, United States; Jhoanny C. Revilla, Weill Cornell Medicine, New York, NY, United States; Dariana Argueta-Zamora, Weill Cornell Medicine, Sunnyside, NY, United States; Lamisa Nubayaat, Weill Cornell Medicine, New York, NY, United States; David Liu, Weill Cornell Medicine, Brooklyn, NY, United States; Hansel Lema, Weill Cornell Medicine, Elmhurst, NY, United States; Priyanka Tiwari, Weill Cornell Medicine, Williston Park, NY, United States; Camilia R. Martin, Weill Cornell Medicine, New York, NY, United States

Background: Obtaining informed consent for clinical research from families of preterm infants is fundamental to advancing neonatal research. However, the unique emotional complexity and logistical challenges surrounding preterm delivery often complicate the consent process within Neonatal Intensive Care Units (NICUs). Identifying patterns and disparities in consent rates can inform targeted recruitment strategies and strengthen ethical practices of neonatal research.

Objective: As part of the initial assessment for an IRB-approved quality improvement initiative in the Level IV NICU at NY-Presbyterian Weill Cornell, we aimed to identify current barriers and drivers of clinical research consent to guide targeted strategies for improvement.

Design/Methods: Data on NICU admissions, eligibility, and consent rates were collected for an interventional clinical trial (CT), an observational study (OB), and a sample biorepository study (BR) from March 2023 to July 2025. Type of study, temporal, and process-related factors influencing parental consent decisions were analyzed.

Results: Results
Of 2019 admitted NICU infants, 441 (22%) infants were eligible for research. Over 83% of eligible families were approached, with most requiring at least two approaches before deciding about study participation (Fig.1A). CT had the lowest consent rate (45%), compared to OB (56%) and BR (54%), although this was not statistically significant (Fig.1B). Regardless of study type or enrollment windows, families who consented to a study did so within the first 4 days after birth (Fig.1C). Common reasons for declining enrollment for all study types included lack of interest in research or feelings of stress and anxiety (Fig.2A). Families who were first approached antenatally versus postnatally showed no difference between consent, decline, or undecided rates (Fig.2B). No trend was observed in consent rates across gestational ages (Fig.2C).

Conclusion(s): The comparable approach frequencies, days of life at consent, and common reasons for declining study enrollment suggests that study type is not the only determinant of study consent success. Our data highlights a critical window for engagement within the first 4 days of life and suggests that research teams can likely prioritize for efficiency an average of 3 approaches with the observation that obtaining a decision after 3 attempts is less likely. These findings underscore the need for targeted strategies that prioritize early, family-centered engagement, optimize staff timing and follow-up, and address the informational and emotional barriers to clinical research consent in the NICU.

Approach and decision outcomes
(A) Number of approaches needed before parents stated a decision regarding participation for a clinical trial (CT), observational study (OB), or sample biorepository study (BR). (B) Percent of subjects approached compared to all eligible admissions and, of those approached, percent of parents that consented, declined, or were unable to decide. (C) Timing that subjects signed consent form from Antepartum admission to infant discharge from the NICU.

Factors influencing decision
(A) Parent self-reported reasons for declining a clinical trial (CT), observational (OB), or biorepository (BR) study. (B) Decision outcomes after initial approach either before birth during Antepartum admission (Ante) or after infant delivery (Post). (C) Decision outcomes based on infant gestational weeks of age at birth.