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Observational study of parental opinion of deferred consent for neonatal research
  1. Samantha Sloss1,
  2. Jennifer Anne Dawson2,3,
  3. Lorraine McGrory2,
  4. Anthony Richard Rafferty2,
  5. Peter G Davis1,2,3,
  6. Louise S Owen1,2,3
  1. 1 Department of Obstetrics and Gynaecology, The University of Melbourne, Melbourne, Victoria, Australia
  2. 2 Newborn Research, Royal Women’s Hospital, Parkville, Victoria, Australia
  3. 3 Clinical Sciences, Murdoch Children’s Research Institute, Parkville, Victoria, Australia
  1. Correspondence to Dr Louise S Owen, Newborn Research, Royal Women's Hospital, Parkville, Victoria, Australia; louise.owen{at}


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.

  • ethics
  • neonatology
  • 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.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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