Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Article
  • Published:

Parental perspectives on a trial using waived informed consent at birth

Journal of Perinatology volume 44, pages 415–418 (2024)Cite this article

Subjects

Abstract

Objectives

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.

Results

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.

Conclusions

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.

This is a preview of subscription content, access via your institution

Access options

Buy this article

  • Purchase on Springer Link
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

Similar content being viewed by others

Data availability

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

References

  1. Katheria A, Schmölzer GM, Janvier A, Kapadia V, Saugstad OD, Vento M, et al. A narrative review of the rationale for conducting neonatal emergency studies with a waived or deferred consent approach. Neonatology. 2023;120:344–52.

    Article  PubMed  Google Scholar 

  2. Rich WD, Auten KJ, Gantz MG, Hale EC, Hensman AM, Newman NS, et al. Antenatal consent in the SUPPORT trial: challenges, costs, and representative enrollment. Pediatrics. 2010;126:e215–21.

    Article  PubMed  Google Scholar 

  3. Katheria A, Reister F, Essers J, Mendler M, Hummler H, Subramaniam A, et al. Association of umbilical cord milking vs delayed umbilical cord clamping with death or severe intraventricular hemorrhage among preterm infants. JAMA: J Am Med Assoc. 2019;322:1877–86.

    Article  Google Scholar 

  4. Katheria AC, Allman P, Szychowski JM, Essers J, Carlo WA, Schmölzer GM, et al. Perinatal outcomes of subjects enrolled in a multicenter trial with a waiver of antenatal consent. Am J Perinatol. 2022;39:904–8.

    Article  PubMed  Google Scholar 

  5. Arnup SJ, McKenzie JE, Hemming K, Pilcher D, Forbes AB. Understanding the cluster randomised crossover design: a graphical illustration of the components of variation and a sample size tutorial. Trials. 2017;18:381.

    Article  PubMed  PubMed Central  Google Scholar 

  6. Katheria AC, Clark E, Yoder B, Schmölzer GM, Yan Law BH, El-Naggar W, et al. Umbilical cord milking in nonvigorous infants: a cluster-randomized crossover trial. Am J Obstet Gynecol. 2023;228:217.e211–7.e214.

    Article  Google Scholar 

  7. Bjorland PA, Øymar K, Ersdal HL, Rettedal SI. Incidence of newborn resuscitative interventions at birth and short-term outcomes: a regional population-based study. BMJ Paediatr Open. 2019;3:e000592.

    Article  PubMed  PubMed Central  Google Scholar 

  8. Schreiner MS, Feltman D, Wiswell T, Wootton S, Arnold C, Tyson J, et al. When is a waiver of consent appropriate in a neonatal clinical trial? Pediatrics. 2014;134:1006–12.

    Article  PubMed  PubMed Central  Google Scholar 

  9. O’Shea N, Doran K, Ryan CA, Dempsey EM. Parental and clinician views of consent in neonatal research. Ir Med J. 2018;111:706.

    PubMed  Google Scholar 

  10. Burgess E, Singhal N, Amin H, McMillan DD, Devrome H. Consent for clinical research in the neonatal intensive care unit: a retrospective survey and a prospective study. Arch Dis Child Fetal Neonatal Ed. 2003;88:F280–285.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  11. Harron K, Woolfall K, Dwan K, Gamble C, Mok Q, Ramnarayan P, et al. Deferred consent for randomized controlled trials in emergency care settings. Pediatrics. 2015;136:e1316–22.

    Article  PubMed  Google Scholar 

  12. Ross CE, Lehmann S, Hayes MM, Yamin JB, Berg RA, Kleinman ME, et al. Community consultation in the pediatric intensive care unit for an exception from informed consent Trial: A survey of patient caregivers. Resusc. Plus. 2023;13:100355.

    Article  PubMed  PubMed Central  Google Scholar 

  13. Rich WD, Katheria AC. Waiver of consent in a trial intervention occurring at birth—how do parents feel? Front Pediatr. 2017;5:56.

    Article  PubMed  PubMed Central  Google Scholar 

  14. Weiss EM, Olszewski AE, Guttmann KF, Magnus BE, Li S, Shah AR, et al. Parental factors associated with the decision to participate in a neonatal clinical trial. JAMA Netw Open. 2021;4:e2032106.

    Article  PubMed  PubMed Central  Google Scholar 

Download references

Funding

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 ClinicalTrials.gov NCT# 03631940.

Author information

Authors and Affiliations

  1. Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA, USA

    Anup C Katheria, Ana Morales, Rebecca A. Dorner, Wade Rich & Neil Finer

  2. University of Alberta, Edmonton, AB, Canada

    Georg M. Schmölzer & Brenda Law

  3. University of Utah, Salt Lake City, UT, USA

    Bradley A. Yoder & Erin Clark

  4. Dalhousie University, Nova Scotia, Canada

    Walid El-Naggar

  5. University of California at San Diego, San Diego, CA, USA

    Benjamin Mooso

  6. Loma Linda University, Loma Linda, CA, USA

    Farha Vora

Authors
  1. Anup C Katheria
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Georg M. Schmölzer
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Brenda Law
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Bradley A. Yoder
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Erin Clark
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Walid El-Naggar
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Ana Morales
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Rebecca A. Dorner
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Benjamin Mooso
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Wade Rich
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Farha Vora
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Neil Finer
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

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.

Ethics declarations

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.

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

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). https://doi.org/10.1038/s41372-023-01853-8

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/s41372-023-01853-8

Search

Advanced search

Quick links