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Parental perspectives on a trial using waived informed consent at birth



To determine parental perspectives in a trial with waived consent.

Study design

Anonymous survey of birth parents with term infants who were randomized using a waiver of consent, administered after infant discharge.


121 (11%) survey responses were collected. Of the 121 responding parents 111 (92%) reported that this form of consent was acceptable and 116 (96%) reported feeling comfortable having another child participate in a similar study. 110 (91%) respondents reported that they both understood the information provided in the consent process and had enough time to consider participation. Four percent had a negative opinion on the study’s effect on their child’s health.


Most responding parents reported both acceptability of this study design in the neonatal period and that the study had a positive effect on their child’s health. Future work should investigate additional ways to involve parents and elicit feedback on varied methods of pediatric consent.

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Data availability

The datasets analyzed during the current study are available from the corresponding author on reasonable request.


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Funding Research reported in this publication was supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institutes of Health under award Number R01HD096023. This trial is registered on NCT# 03631940.

Author information

Authors and Affiliations



AK and NF conceptualized and designed the study, drafted the initial manuscript, and critically reviewed and revised the manuscript. AM, WR designed the data collection instruments, collected data, carried out the initial analyses, and critically reviewed and revised the manuscript. BM critically reviewed, revised the manuscript, and added an IRB perspective to the trial. GS; BL; BY; EC; WE, FV; and RD coordinated and supervised data collection at their individual sites, and critically reviewed and revised the manuscript for important intellectual content. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

Corresponding author

Correspondence to Anup C Katheria.

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Competing interests

Dr. Katheria reported receiving grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. No other disclosures were reported.

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Katheria, A.C., Schmölzer, G.M., Law, B. et al. Parental perspectives on a trial using waived informed consent at birth. J Perinatol 44, 415–418 (2024).

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