Development and Preliminary Evaluation of a Questionnaire on Parental Informed Consent in Neonatal Research

Abstract

Background: Advances in neonatology and paediatric pharmacology have markedly improved neonatal survival, particularly among preterm and critically ill infants. At the same time, clinical research constitutes the cornerstone for generation of evidence on the safety and efficacy of therapeutic interventions. However, neonatal participation in research relies on parental informed consent, a complex and multifactorial process shaped by cognitive, emotional, and cultural factors. In Greece, evidence regarding the determinants of parental consent for neonatal clinical research remains scarce. The aim of this study was to develop and conduct a preliminary evaluation of a questionnaire designed to assess parents’ perceptions and attitudes toward informed consent for participation of their offspring in neonatal clinical studies. Methods: A structured questionnaire was developed based on the international literature and the principles of informed consent. The instrument comprised five domains assessing knowledge and understanding of research, the informed consent process, trust in healthcare professionals, parental emotions, and sociodemographic characteristics. Content validity was assessed by an expert panel, followed by pilot testing in 20 parents. Preliminary evaluation of temporal stability was performed using Cohen’s kappa coefficient and weighted kappa. The study was conducted in accordance with the principles of the Declaration of Helsinki. Results: The questionnaire showed variable test–retest agreement across items and domains in the pilot sample. Domains covering cognitive aspects of research participation exhibited greater stability over time compared with emotional dimensions, which showed higher variability between measurements. Questions related to study type and trust in healthcare professionals demonstrated higher levels of reliability. Conclusions: This study describes the development and preliminary evaluation of a questionnaire designed to explore factors potentially influencing parental consent for participation in neonatal research in Greece. The findings provide preliminary evidence regarding the temporal stability of individual questionnaire items while also identifying items that may require further evaluation or refinement. Further evaluation in larger and more diverse populations, including a more comprehensive assessment of its measurement properties, is warranted before broader research application.