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


CONCLUSIONS
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.
Korotchikova
Irina
I
Department of Paediatrics and Child Health, University College Cork, Ireland. I.Korotchikova@ucc.ie
Boylan
Geraldine B
GB
Dempsey
Eugene M
EM
Ryan
C Anthony
CA
D000328:Adult; D001290:Attitude; D003657:Decision Making; D004569:Electroencephalography; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007258:Informed Consent; D008297:Male; D010290:Parents; D018579:Patient Selection