Trust and consent: a prospective study on parents' perspective during a neonatal trial

Area of Science:

• Neonatal intensive care research ethics
• Clinical trial informed consent processes
• Parent-physician communication in medical research

Background:

• Informed consent is crucial in neonatal intensive care unit (NICU) research.
• Understanding parent and physician experiences in the consent process is vital for ethical research conduct.
• Prenatal informed consent presents unique challenges in the NICU setting.

Purpose of the Study:

• To explore parents' and physicians' experiences with the informed consent interview in a NICU randomized clinical trial.
• To identify factors influencing parental decisions during the consent process.
• To describe perspectives on prenatal informed consent for clinical trials.

Main Methods:

• A mixed-methods study analyzing qualitative and quantitative interview data from parents and physicians.
• Thematic discourse analysis was used to review interview records.
• The study was conducted in a tertiary NICU as an ancillary study to the Prettineo randomized clinical trial.

Main Results:

• Parents demonstrated good recall and understanding of the trial's objectives and design.
• A positive experience and trust were key factors for parental consent; misunderstanding was a primary reason for refusal.
• Prenatal consent can be compromised by prior study participation, father's absence, or perceived lack of imminent birth.

Conclusions:

• Comparing parent and physician perspectives aids in addressing sensitive issues like information content and timing in research consent.
• Different study types pose unique ethical dilemmas requiring individualized consent discussions.
• Optimizing informed consent processes in NICU research is essential for ethical and effective clinical trials.