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Informed consent for a neonatal clinical trial: parental experiences and perspectives

Abstract

Objective

There is a variability regarding timing of consent and personnel used in patient recruitment for neonatal research. We explored the associations between the study personnel and timing of consent with parents’ decisional conflict and ultimately their decision to enroll.

Study design

This was a multi-site, cross-sectional survey conducted between August 2015 and October 2017. Participants were parents approached to enroll their 24–28-week infant in a clinical trial. Parents completed an interviewer-administered 61-item questionnaire.

Results

Overall, 163 surveys were completed; 105 by parents of enrolled infants and 58 by parents of non-enrolled infants (54.5% participation rate). Neither the individual requesting nor timing of consent was associated with parents’ knowledge score, decisional conflict, or decision to enroll. Parents preferred to be approached prenatally and by their infant’s doctor.

Conclusion

Study designers and IRBs may allow flexibility in personnel and timing of consent as it is respectful of parents and may enhance trial enrollment.

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Acknowledgements

We wish to thank the research coordinators and bedside nurses involved in the PENUT Trial as well as this study. We wish to acknowledge US taxpayers for providing the funding to support the National Institutes of Health and the PENUT study. We are indebted to the parents for their willingness to participate.

PENUT Neonatal Informed Consent Working Group

Bonnie Arzuaga, Catherine L. Baker, Sandra Beauma, Tiffany Brown, Rita Daly, Melanie Drummond, Natalie Dweck, Ariana Franco, Clare Giblin, Pamela Hedrick, Jordan Kase, Janine Khan, Kristi Lanier, Melanie Mason, Jana McConnell, Deborah Ott, Palak Patel, Patricia Robinson, Molly Schau, Vivek Vijayamandhavan, Tiglath Ziyeh.

Author contributions

ARS conceptualized and designed the study, designed data collection instruments, coordinated data collection, collected data, drafted the initial manuscript, and reviewed and revised the manuscript. BSW and SJ conceptualized and designed the study, designed data collection instruments, drafted the initial manuscript, and reviewed and revised the manuscript. DW conceptualized and designed the study, designed data collection instruments, and reviewed and revised the manuscript. AS was the project coordinator, conceptualized and designed the study, designed data collection instruments, coordinated and supervised data collection, and collected data and reviewed the manuscript. KH and PH carried out the data analyses, and reviewed and revised the manuscript. SG helped refine the data collection instrument, collected data, coordinated and supervised data collection, and reviewed and revised the manuscript. SC helped design the study and data collection instruments, collected data, and reviewed the manuscript. KAA, CEB, IDF, CK, and RKO helped refine the data collection instrument, coordinated and supervised data collection, and reviewed and revised the manuscript. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work. We also wish to thank the members of the PENUT Neonatal Informed Consent Working Group for their time and contributions to this research.

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Correspondence to Anita R. Shah.

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The authors declare that they have no conflict of interest.

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Shah, A.R., Wilfond, B.S., Silvia, A. et al. Informed consent for a neonatal clinical trial: parental experiences and perspectives. J Perinatol 38, 865–872 (2018). https://doi.org/10.1038/s41372-018-0119-6

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