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

PURPOSE OF REVIEW: With the recent advances in neonatal care, resuscitation of periviable neonates and challenges to conducting clinical research and funding, efficient clinical trials with relevant outcomes are pivotal to direct the future of neonatology. RECENT FINDINGS: Parents of neonates in the Neonatal ICU are supportive and hold positive views of clinical research. Timing and who approaches the parents plays a great role in parents' perception of a clinical trial. Parents prefer a bigger role for the clinical team at least when introducing the idea of research. The consent process has evolved, and newer technology should be incorporated to make it simple and more clear. Consenting mothers in labor remains a point of contention as timing of consent and ability to retain information matters. Different types of consent can be used based on timing of intervention of a research trial, to allow for efficient and diverse enrollment. SUMMARY: The challenges inherent to conducting research in neonatology have not received the attention it deserves, especially when it comes to interventional trials, raising questions about equity of research in this patient cohort. Parents view research positively and are supportive provided that the timing is appropriate and language is clear.