Parental Consent to a Neonatal Clinical Study: The Roles of Uncertainty, Burden of Sample Collection and Societal Expectations.

Aim: Recruiting participants for neonatal clinical studies may be challenging because parental consent is required shortly after birth. This study aimed to explore reasons for parental decline of participation in a neonatal study.

Method: This qualitative sub-study was conducted in the Capital Region of Denmark between June 2022 and April 2023. Parents of healthy term newborn infants who declined participation in the PrePhage study, a study investigating the transfer of faecal filtrate for the prevention of necrotising enterocolitis, were included. These parents were interviewed through semi-structured telephone interviews. Data were analysed using thematic analysis.

Results: Ten parents (five mothers and five fathers of 10 different newborn infants) participated. All were first-time parents. Three themes were identified: the first theme, uncertainty of the unknown, captured how early parenthood influenced willingness to engage. The second theme, challenges and discomfort related to sample collection, reflected logistical burdens and discomfort associated with faecal samples. The third theme, balancing societal expectations, described the tension between the social value of research and expressed guilt for declining participation.

Conclusion: Emotional, logistical and societal factors influenced parents' decision to decline participation in neonatal research. Future enrolment strategies should consider the timing of approach and aim to minimise participation burden.

Trial registration: ClinicalTrials.gov identifier: NCT05272579 and NCT05272566.