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Informed consent in the NICU setting: an ethically optimal model for research solicitation
Lisa Golec1, Sharyn Gibbins, Michael S Dunn
1Sunnybrook and Women's College Health Sciences Centre, 76 Grenville Street, Toronto, Ontario M5S 1B2, Canada.
Insights
Recruiting infants for Neonatal Intensive Care Unit (NICU) research requires ethical considerations. A proposed model enhances parental autonomy and informed consent during the recruitment process.
Area of Science:
- Medical research ethics
- Neonatal intensive care
Background:
- Patient recruitment in Neonatal Intensive Care Units (NICUs) presents unique challenges.
- Existing recruitment models are debated for their effectiveness and ethical implications.
Purpose of the Study:
- To discuss current and proposed patient recruitment models for the NICU setting.
- To present a systematic approach to the consent process prioritizing parental autonomy.
Main Methods:
- The proposed model emphasizes informing parents of research and rights before solicitation.
- It includes asking for permission to approach, one study at a time, relevance to infant status, minimizing information overload, allowing adequate decision time, and implementing waiting periods.
Main Results:
- The systematic approach aims to protect and promote parental autonomy in research decisions.
- This model is designed to facilitate a more informed choice for parents regarding their infant's participation in research.
Conclusions:
- The proposed recruitment and consent model offers an ethically optimal approach for neonate inclusion in research.
- Following this model may improve parental ability to make truly informed choices.
Abstract:
Recruiting patients for studies in the Neonatal Intensive Care Unit is a complex endeavour. Much discussion has occurred regarding the optimal recruitment "model" for this environment. This paper discusses current and suggested recruitment models for the NICU setting and presents a systematic approach to the consent process that focuses on the protection and promotion of parental autonomy. The proposed model incorporates several key considerations for an ethically optimal approach to the inclusion of neonates in research: informing parents about research and their rights prior to any solicitation, asking parents if they wish to be approached for research, approaching for one study at a time, assuring the study is relevant to the infants' current clinical status, minimising information overload, allowing parents appropriate time (which will vary from study to study) to consider their choice, and providing a waiting period between subsequent approaches. It is argued that parental ability to make a truly informed choice may be improved when following the proposed model.
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