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Deferred Consent in Neonatal Clinical Research: Why, When, How?

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A Commentary to this article was published on 28 October 2021

Abstract

Deferred consent has gained traction in some countries as a possible adjunct to prospective consent for evaluating emergency therapies in the neonatal population. This form of consent has been shown to increase recruitment of acutely and critically unwell patients, potentially reduce parent decision-making burden, and provide more robust evidence for clinical treatments where equipoise exists. However, deferred consent raises complex ethical concerns and guidelines for its use vary across different jurisdictions. The views of all stakeholders, including neonatal providers and parents, are important in determining the appropriateness of deferred consent in high-risk patients. Deferred consent may be ethically justifiable for assessing various treatments, particularly those used in emergency medical management. We present a framework based on neonatal deferred consent trials that assess both non-drug and drug interventions, our experience conducting deferred consent neonatal studies in Australia, and the views of providers and parents on how to best implement deferred consent in the neonatal research setting.

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Author information

Authors and Affiliations

  1. Newborn Research Centre, The Royal Women’s Hospital, Melbourne, VIC, Australia

    Dilini I. Imbulana, Louise S. Owen, Peter G. Davis & Brett J. Manley

  2. Neonatal Medicine, The Royal Children’s Hospital, Melbourne, VIC, Australia

    Trisha M. Prentice

  3. Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia

    Trisha M. Prentice

  4. Clinical Sciences, Murdoch Children’s Research Institute, Melbourne, VIC, Australia

    Louise S. Owen, Trisha M. Prentice, Peter G. Davis & Brett J. Manley

  5. Department of Obstetrics and Gynaecology, The University of Melbourne, Melbourne, VIC, Australia

    Louise S. Owen, Peter G. Davis & Brett J. Manley

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  1. Dilini I. Imbulana
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  2. Louise S. Owen
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  4. Peter G. Davis
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  5. Brett J. Manley
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Correspondence to Dilini I. Imbulana.

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DII drafted the first manuscript and contributed to the editing process of the final draft of the manuscript. LSO revised the manuscript and contributed to the editing process of the final draft of the manuscript. TMP revised the manuscript and contributed to the editing process of the final draft of the manuscript. PGD revised the manuscript and contributed to the editing process of the final draft of the manuscript. BJM revised the manuscript and contributed to the editing process of the final draft of the manuscript. All authors approved the final manuscript as submitted.

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Imbulana, D.I., Owen, L.S., Prentice, T.M. et al. Deferred Consent in Neonatal Clinical Research: Why, When, How?. Pediatr Drugs 23, 565–573 (2021). https://doi.org/10.1007/s40272-021-00473-z

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