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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.
Objective:
To assess the feasibility and parental acceptability of delayed consent for research involving blood samples collected from febrile infants aged 60 days or younger during emergent care.
Methods:
This was a substudy of a pilot trial at a tertiary pediatric ED to detect biomarkers of serious bacterial infections among febrile young infants. Families were provided an introductory letter indicating that, after clinically necessary blood tests, a small volume of additional blood would be collected and stored for research for which they could opt out at any time. After hospital discharge, all families received telephone follow-up for a delayed consent discussion, allowing them to accept or refuse participation in the main biomarker trial. A 6-month consecutive sample of parents was invited to complete a questionnaire regarding the acceptability of research blood collection with delayed telephone consent.
Results:
Among 345 consecutive infants, 22 (6.4%) families opted out of research blood collection during ED care, and 136 (42.1%) had research blood collected after clinical sampling. Nearly all families (333/345; 96.5%) had telephone follow-up, and questionnaires were completed by 312/333 (90.4%). Most families found delayed consent for research blood collection acceptable (271/312; 86.9%) or somewhat acceptable (34/312; 10.9%), and 81.5% provided consent to use their infants' research blood samples.
Conclusions:
Delayed consent for research is feasible andhighly acceptable to parents of febrile infants in the ED. This methodology may minimize stress during emergent care, enhance inclusivity, and facilitate timely, ethical pediatric research when there are barriers to standard prospective consent. Broader implementation should consider study risk, context, and ethical oversight.
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