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Published on: August 25, 2014
Informed consent for neonatal trials: practical points to consider and a check list
Beate Aurich1, Eric Vermeulen2, Valéry Elie1
1Department of Paediatric Clinical Pharmacology and Pharmacogenetics, Robert Debré Hospital, 48 Boulevard Sérurier, Institut National de la Santé et de la Recherche Médicale (INSERM), Paris, France.
Insights
Obtaining informed consent for critically ill neonates is complex. Open communication and trust-building are crucial for effective parental decision-making in neonatal research.
Area of Science:
- Neonatal Medicine
- Bioethics
- Clinical Research
Background:
- Informed consent for critically ill neonates presents unique ethical challenges.
- Parental decision-making is influenced by child's condition, risk-benefit analysis, emotional state, and clinical team relationship.
Purpose of the Study:
- To explore the complexities of obtaining informed consent from parents of critically ill neonates.
- To identify factors influencing parental decision-making and propose best practices for ethical consent processes.
Main Methods:
- Qualitative analysis of factors influencing parental consent.
- Review of ethical considerations in neonatal research consent.
- Discussion of communication strategies and continuous consent models.
Main Results:
- Parental consent is affected by perceived risks, benefits, and the parent-clinician relationship.
- Parents may prefer joint consent, regardless of legal requirements.
- Addressing misconceptions and fostering trust are vital for valid consent.
Conclusions:
- Informed consent in neonatal research is a dynamic process requiring trust and open dialogue.
- Effective communication training for investigators is recommended.
- Involving parents in the consent process development is essential for ethical neonatal research.
Abstract:
Obtaining informed consent from parents of critically ill neonates can be challenging. The parental decision-making process is influenced by the severity of the child's condition, the benefit-risk balance, their emotional state and the quality of the relationship with the clinical team. Independent of local legislation, parents may prefer that consent is sought from both. Misconceptions about the absence of risks or unrealistic expectations about benefits should be openly addressed to avoid misunderstandings which may harm the relationship with the clinical team. Continuous consent can be sought where it is unclear whether the free choice of parental consent has been compromised. Obtaining informed consent is a dynamic process building on trusting relationships. It should include open and honest discussions about benefits and risks. Investigators may benefit from training in effective communication. Finally, involving parents in neonatal research including the development of the informed consent form and the process of obtaining consent should be considered standard practice.
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