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Created on : 28 Jun 2004
Modified on : 01 Nov 2018

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Bibliographical entry (without author) :

Neonatal Research and the Validity of Informed Consent Obtained in the Perinatal Period. Journal of Perinatology 2004;24(7): 409-415.

Author(s) :

Ballard HO, Shook LA, Desai NS, Anand KJS.

Year of publication :


URL(s) :

Résumé (français)  :

Abstract (English)  :

BACKGROUND: Consent for participation in clinical research is considered valid if it is informed, understood, and voluntary. In the case of minors, parents give permission for their child to participate in research studies after being presented with all information needed to make an informed decision. Although informed consent is a vital component of clinical research, there is little information evaluating its validity in neonatal intensive-care populations. The objective of this project was to determine the validity of informed consent obtained from parents of infants enrolled in the multicenter randomized research study, neurologic outcomes and pre-emptive analgesia in the neonate (NEOPAIN).

DESIGN/METHODS: Parents of infants who survived to discharge and had signed consent for their newborn to participate in the NEOPAIN study at the University of Kentucky were asked 20 open-ended questions to determine their level of understanding about the NEOPAIN study. The NEOPAIN consent form, which had been approved by the University of Kentucky Medical Institutional Review Board (IRB), was used to formulate these questions. Questions addressed the timing of consent, parental understanding of the purpose, benefits, and risks of the study, the voluntary nature of the project, and their willingness to enroll in future studies if the opportunity presented. Answers were scored on a Likert scale, with 1 for no understanding and 5 for complete understanding.

RESULTS: Five of 64 parents (7.8%) had no recollection of the NEOPAIN study or of signing consent. Of those who remembered the study, only 67.8% understood the purpose of the study, with a higher proportion of the mothers than fathers knowing the purpose of the study (73.3% vs 57.1%), (p=0.029). Of those who understood the purpose of the study 95% were able to verbalize the benefits, but only 5% understood any potential risks. No parents reported feeling pressured or coerced to sign consent for the project and all parents reported they would enroll their child in additional studies if asked.

CONCLUSIONS: Valid consent in the antenatal/perinatal population is difficult, if not impossible, to obtain. To maximize validity of consent in the antenatal/perinatal population every effort should be made to include mothers in the consent process. Additional attention during the consent process should be given to possible risks of the study.

Sumário (português)  :

Resumen (español)  :

Full text (public) :

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Argument (français) :

Pour maximiser la validité du consentement dans la population prénatale et périnatale, tout devrait être mis en œuvre pour inclure les mères dans le processus de consentement.

Argument (English):

To maximize validity of consent in the antenatal/perinatal population every effort should be made to include mothers in the consent process.

Argumento (português):

Para maximizar a validade do consentimento na população pré-natal e perinatal, todos os esforços devem ser feitos para incluir as mães no processo de consentimento.

Argumento (español):

Keywords :

➡ evidence-based medicine/midwifery ; newborn care ; obstetric and gynecologic violence obstetric violence, obstetrical violence ; deontology ; informed consent

Author of this record :

Cécile Loup — 28 Jun 2004
➡ latest update : Bernard Bel — 01 Nov 2018

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