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

Abstract

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.