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Presence of both parents during consent process in non‐therapeutic neonatal research increases positive response
Author(s) -
Korotchikova Irina,
Boylan Geraldine B,
Dempsey Eugene M,
Ryan C Anthony
Publication year - 2010
Publication title -
acta pædiatrica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.772
H-Index - 115
eISSN - 1651-2227
pISSN - 0803-5253
DOI - 10.1111/j.1651-2227.2010.01873.x
Subject(s) - voluntariness , informed consent , medicine , parental consent , harm , competence (human resources) , family medicine , psychiatry , pediatrics , alternative medicine , psychology , social psychology , law , pathology , political science
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.