Informed consent in the NICU setting: an ethically optimal model for research solicitation

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.