Eur J Pediatr. 2026 Apr 8;185(5):244. doi: 10.1007/s00431-026-06865-y.
ABSTRACT
Obtaining informed consent is crucial in clinical research. This process is particularly challenging in a Neonatal Intensive Care Unit. Parents of critically ill neonates already experience high emotional distress, and soliciting consent for research may exacerbate this burden. As evidence-based medicine is essential to improve neonatal care, clinical trials in neonates require adequate and non-selective enrollment. This study aims to find facilitators and barriers influencing the consent process in neonatal research. A scoping review was conducted using PubMed, Embase, Web of Science, Cochrane CENTRAL, CINAHL, and Google Scholar to identify peer-reviewed articles published in English, focusing on factors influencing parental decisions regarding their child’s enrollment in neonatal research. Identified factors were thematically categorized and labeled based on the level of evidence and direction of influence. From the 2108 retrieved articles, 20 were included for analysis. Common facilitators of research participation were perceived benefits for the child, altruistic motives to benefit or help other children, and the wish to contribute to knowledge and science. Notably, a higher severity of illness facilitated consent. Important barriers to participation were parental stress and fear, concerns about risks for the child, and the logistical burden of participation.
CONCLUSION: Obtaining consent in neonatal research is a complex process influenced by a nuanced balance between facilitators and barriers. The findings highlight the importance of providing adequate support to reduce the burden of participation. Through trust and clear communication, parents can feel empowered to make well-informed decisions, even in the most challenging situations.
WHAT IS KNOWN: • Obtaining informed consent for research in the NICU is challenging due to the critical illness of the neonates, parental stress, and time constraints, often resulting in low and selective enrollment.
WHAT IS NEW: • Parents are often motivated by perceived benefits, altruism, and the wish to contribute to knowledge and science, while parental fear, perceived risks, and burden of participation are barriers to research participation.
PMID:41949671 | DOI:10.1007/s00431-026-06865-y
