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Deferred Consent in Neonatal Clinical Research: Why, When, How?
Dilini I Imbulana1, Louise S Owen2,3,4, Trisha M Prentice5,6,3
1Newborn Research Centre, The Royal Women's Hospital, Melbourne, VIC, Australia. dilini.imbulana2@thewomens.org.au.
Insights
Deferred consent for neonatal research can improve patient recruitment and evidence quality in emergency situations. Ethical considerations and stakeholder views are crucial for its appropriate implementation in critically ill infants.
Area of Science:
- Neonatal research ethics
- Clinical trial methodology
- Emergency medicine
Background:
- Deferred consent is emerging as a method to enhance recruitment in neonatal research, particularly for emergency therapies.
- It may reduce parental burden and yield stronger evidence when clinical equipoise exists.
- Ethical challenges and varying jurisdictional guidelines necessitate careful consideration.
Purpose of the Study:
- To explore the ethical justification and practical implementation of deferred consent in neonatal research.
- To present a framework for deferred consent trials in neonates, including drug and non-drug interventions.
- To incorporate the perspectives of healthcare providers and parents on deferred consent practices.
Main Methods:
- Review of deferred consent principles and ethical considerations in neonatal research.
- Presentation of a framework derived from Australian deferred consent neonatal trials.
- Inclusion of stakeholder (provider and parent) views on implementation strategies.
Main Results:
- Deferred consent can ethically facilitate research in emergency neonatal care, improving recruitment and evidence quality.
- A framework for conducting deferred consent trials in neonates has been developed.
- Stakeholder engagement is vital for successful and ethical implementation.
Conclusions:
- Deferred consent offers a viable ethical approach to neonatal research, especially in emergencies.
- Careful planning and consideration of stakeholder perspectives are essential for its appropriate use.
- Further research and clear guidelines are needed to optimize deferred consent practices.
Abstract:
Deferred consent has gained traction in some countries as a possible adjunct to prospective consent for evaluating emergency therapies in the neonatal population. This form of consent has been shown to increase recruitment of acutely and critically unwell patients, potentially reduce parent decision-making burden, and provide more robust evidence for clinical treatments where equipoise exists. However, deferred consent raises complex ethical concerns and guidelines for its use vary across different jurisdictions. The views of all stakeholders, including neonatal providers and parents, are important in determining the appropriateness of deferred consent in high-risk patients. Deferred consent may be ethically justifiable for assessing various treatments, particularly those used in emergency medical management. We present a framework based on neonatal deferred consent trials that assess both non-drug and drug interventions, our experience conducting deferred consent neonatal studies in Australia, and the views of providers and parents on how to best implement deferred consent in the neonatal research setting.
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