A flexible, longitudinal and surrogate consent model: Consent of Infants for Neonatal Secondary-use research (CoINS) Model

Abstract

Documenting healthcare, along with technology enabling capture of streaming patient telemetry, can deliver large datasets offering opportunities to discover new insights primarily identified through retrospective secondary use research. Research involving health data requires consent of the subject patient or someone with the power to speak on that patient’s behalf. Flexible consent models that capture consent preferences while allowing updates as preferences change are needed. This research proposes and demonstrates one solution in a case study collecting surrogate consent from parents for the physiological data of infant inpatients in the Neonatal Intensive Care Unit (NICU) and attaching this consent as a wrapper controlling access to their data. 145 parents were approached and 134 provided consent: with 78 percent of infants consented during their first week of life. This research supports the contention that using a flexible consent approach enhances willingness to consent use of infant’s health data for secondary research purposes.