Observational study of parental opinion of deferred consent for neonatal research

Abstract

Objective: To evaluate the opinions of parents of newborns following their infant's enrolment into a neonatal research study through the process of deferred consent.

Design: Mixed-methods, observational study, interviewing 100 parents recently approached for deferred consent.

Setting: Tertiary-level neonatal intensive care unit, Melbourne, Australia.

Results: All 100 parents interviewed had consented to the study/studies using deferred consent; 62% had also experienced a prospective neonatal consent process. Eighty-nine per cent were 'satisfied' with the deferred consent process. The most common reason given for consenting was 'to help future babies'. Negative comments regarding deferred consent mostly related to the timing of the consent approach, and some related to a perceived loss of parental rights. A deferred approach was preferred by 51%, 24% preferred a prospective approach and 25% were unsure. Those who thought prospective consent would not have been preferable cited impaired decision-making, inappropriate timing of an approach before birth and their preference for removal of the decision-making burden via deferred consent. Seventy-seven per cent thought they would have given the same response if approached prospectively; those who would have declined reported that a prospective approach under stressful conditions was unwelcome and too overwhelming.

Conclusion: In our sample, 89% of parents of infants enrolled in neonatal research using deferred consent considered it acceptable and half would not have preferred prospective consent. The ability to make a more considered decision under less stressful circumstances was key to the acceptability of deferred consent.

Keywords: ethics; neonatology; qualitative research.