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Deferred consent for delivery room studies: the providers' perspective.
Maria C den Boer1,2, Mirjam Houtlosser2, Elizabeth E Foglia3
1Division of Neonatology, Leiden University Medical Center, Leiden, Netherlands m.c.den_boer@lumc.nl.
Archives of Disease in Childhood. Fetal and Neonatal Edition
|August 21, 2019
Summary
Neonatal care providers find deferred consent acceptable for delivery room (DR) studies, though they have concerns. Improving its actual use in DR research requires addressing parental autonomy and ethical review processes.
Area of Science:
- Neonatal research ethics
- Clinical trial consent procedures
Background:
- Delivery room (DR) studies are crucial for neonatal care advancements.
- Informed consent in DR research presents unique ethical and logistical challenges.
- Deferred consent is an alternative to immediate prospective consent in DR research.
Purpose of the Study:
- To explore neonatal care providers' perspectives on deferred consent for DR studies.
- To understand the perceived benefits and challenges of deferred consent in real-world neonatal research settings.
Main Methods:
- Semistructured interviews were conducted with 46 neonatal intensive care unit (NICU) staff.
- Participants were from two major academic medical centers with differing consent approaches for DR studies.
- Qualitative data analysis was performed using Atlas.ti V.7.0.
Main Results:
- Providers prefer prospective consent but acknowledge the necessity of deferred consent for DR management.
- Concerns were raised regarding parental autonomy, consent communication, and ethical review of deferred consent protocols.
- Experiences with deferred consent varied, with positive outcomes linked to effective communication and timing.
Conclusions:
- Deferred consent is perceived as acceptable for DR studies, but its implementation can be enhanced.
- Addressing provider concerns and optimizing communication strategies are key to improving deferred consent practices.
- Further refinement of ethical review processes for DR studies using deferred consent is warranted.