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.
- qualitative research
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Contributors SS contributed to data collection and interpretation and wrote the first draft of the manuscript. JAD contributed to data collection and interpretation and manuscript revision. LMcG contributed to study design, data collection and manuscript revision. ARR contributed to data collection and manuscript revision. PGD contributed to study conception and design and manuscript revision. LSO contributed to study conception and design, data collection and interpretation and manuscript revision.
Funding National Health and Medical Research Council Fellowships: PGD: Australian National Health and Medical Research Council Programme Grant #1113902, Australian National Health and Medical Research Council Practitioner Fellowship #105911; LSO: Australian National Health and Medical Research Council Early Career Fellowship #1090678.
Disclaimer The NHMRC had no role in study design, data collection, analysis, or interpretation, manuscript writing or decision to publish.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval This study was approved by the institutional Human Research and Ethics Committees.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request.
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