Neonatal trials and informed consent in the NICU: a literature review

Area of Science:

• Neonatal care and clinical research ethics.

Background:

• Advances in neonatal care necessitate efficient clinical trials for periviable neonates.
• Conducting research and securing funding in neonatology presents significant challenges.

Purpose of the Study:

• To review the current landscape of neonatal clinical research.
• To identify factors influencing parental participation and consent in neonatal trials.
• To address challenges in conducting interventional research in neonatology.

Main Methods:

• Review of parental perceptions and experiences with neonatal clinical research.
• Analysis of factors influencing consent processes.
• Examination of challenges in neonatal interventional trials.

Main Results:

• Parents of neonates in the Neonatal ICU are generally supportive of clinical research.
• Timing of approach and clarity of information significantly impact parental perception and consent.
• The clinical team's role in introducing research is preferred by parents.
• Innovative technologies can enhance the consent process.
• Consenting mothers in labor requires careful consideration of timing and information retention.
• Flexible consent strategies can improve enrollment efficiency and diversity.

Conclusions:

• Conducting interventional research in neonatology faces significant challenges, impacting research equity.
• Parental support for neonatal research is high when consent is timely, clear, and appropriately managed.