Alpha 2.0
Login Register
» Articles » PMID: 38129598

Parental Perspectives on a Trial Using Waived Informed Consent at Birth

Overview
Journal J Perinatol
Specialty Gynecology & Obstetrics
Date 2023 Dec 22
PMID 38129598
Authors
Anup C Katheria
Georg M Schmolzer
Brenda Law
Bradley A Yoder
Erin Clark
Walid El-Naggar
Ana Morales
Rebecca A Dorner
Benjamin Mooso
Wade Rich
Farha Vora
Neil Finer
Affiliations
Soon will be listed here.
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.

Citing Articles

Piloting the better research interactions for every family (BRIEF) researcher intervention to support recruitment for a neonatal clinical trial: parent experience and infant enrollment.

Weiss E, Duenas D, Kelsh A, Gray M, Oslin E, Mcneil D J Perinatol. 2025; .

PMID: 40038540 DOI: 10.1038/s41372-025-02245-w.

References
1.
Katheria A, Schmolzer G, Janvier A, Kapadia V, Saugstad O, Vento M . A Narrative Review of the Rationale for Conducting Neonatal Emergency Studies with a Waived or Deferred Consent Approach. Neonatology. 2023; 120(3):344-352. DOI: 10.1159/000530257. View
2.
Rich W, Auten K, Gantz M, Hale E, Hensman A, Newman N . Antenatal consent in the SUPPORT trial: challenges, costs, and representative enrollment. Pediatrics. 2010; 126(1):e215-21. PMC: 3057215. DOI: 10.1542/peds.2009-3353. View
3.
Katheria A, Allman P, Szychowski J, Essers J, Carlo W, Schmolzer G . Perinatal Outcomes of Subjects Enrolled in a Multicenter Trial with a Waiver of Antenatal Consent. Am J Perinatol. 2020; 39(8):904-908. PMC: 8788902. DOI: 10.1055/s-0040-1719184. View
4.
Arnup S, McKenzie J, Hemming K, Pilcher D, Forbes A . Understanding the cluster randomised crossover design: a graphical illustraton of the components of variation and a sample size tutorial. Trials. 2017; 18(1):381. PMC: 5557529. DOI: 10.1186/s13063-017-2113-2. View
5.
Bjorland P, Oymar K, Ersdal H, Rettedal S . Incidence of newborn resuscitative interventions at birth and short-term outcomes: a regional population-based study. BMJ Paediatr Open. 2020; 3(1):e000592. PMC: 6936999. DOI: 10.1136/bmjpo-2019-000592. View