Presence of both parents during consent process in non-therapeutic neonatal research increases positive response

Abstract

Aim: To investigate factors that influenced parental consent/non-consent in a non-therapeutic electroencephalogram (EEG) study in healthy newborns.

Methods: Parents of healthy newborns were approached to participate in a neonatal EEG study within 36 h of birth. The rationale and risks/benefits of the study were explained. Any concerns were discussed, and detailed information about the EEG study was provided in the consent form. In the case of refusing/withdrawing consent, an informal interview was used to investigate the reasons, which were subsequently analysed and grouped according to the four principles of the consent process.

Results: A total of 123 parents were included in the study. Parental consent was obtained in 72/123 (59%) cases, 10/123 (8%) parents subsequently withdrew their consent and 41/123 (33%) parents refused to participate in the study. Consent was more likely if both parents were present (p < 0.0001). When the mothers were approached alone, obtaining consent was significantly more difficult within the first 6 hours of delivery, compared to a later approach (37% vs. 67% respectively; p = 0.009). Refusals were classified into issues of voluntariness (7%), informed choice (10%), understanding (54%) and competence (29%).

Conclusion: Parents of healthy newborns demonstrated a positive attitude towards non-therapeutic neonatal research with maximal consent occurring when both parents were present. Parental perception of harm was the main reason for declining consent.