Delayed Consent for Research During the Emergent Care of Febrile Young Infants: Feasible, Acceptable, Doable

Brett Burstein1,2, Kelley-Anne Dionne3, Alexandra Yannopoulos3

  • 1Montreal Children's Hospital, Division of Pediatric Emergency Medicine, Department of Pediatrics, McGill University Health Centre, Montreal, Quebec, Canada.

Insights

Delayed consent for research blood collection is feasible and acceptable for febrile infants. This method enhances ethical pediatric research by reducing stress during emergent care.

Area of Science:

  • Pediatric Emergency Medicine
  • Clinical Research Ethics
  • Biomarker Discovery

Background:

  • Emergent care for febrile infants presents challenges for obtaining informed consent for research.
  • Standard prospective consent may be difficult due to the critical condition of infants and parental stress.

Purpose of the Study:

  • To evaluate the feasibility and parental acceptability of a delayed consent approach for collecting blood samples from febrile infants.
  • To assess the potential of delayed consent in facilitating pediatric research in emergency settings.

Main Methods:

  • A substudy within a pilot trial involving febrile infants (≤60 days) in a pediatric emergency department (ED).
  • Families received information about optional research blood collection with the ability to opt out.
  • Delayed consent was obtained via telephone follow-up after hospital discharge.
  • Parental acceptability was assessed using a questionnaire.

Main Results:

  • A low opt-out rate (6.4%) was observed during ED care.
  • High rates of telephone follow-up (96.5%) and questionnaire completion (90.4%) were achieved.
  • The majority of parents found delayed consent acceptable (97.8%) and provided consent for research blood sample use (81.5%).

Conclusions:

  • Delayed consent for research involving blood samples from febrile infants is a feasible and highly acceptable method.
  • This approach can reduce parental stress during emergent care and improve inclusivity in pediatric research.
  • Consideration of study risk, context, and ethical oversight is crucial for broader implementation.
Abstract

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