A Flexible Parental Engaged Consent Model for the Secondary Use of Their Infant’s Physiological Data in the Neonatal Intensive Care Context

Abstract

The secondary use of health data, especially the use of physiological data for research holds many opportunities for improving the current understanding of neonatal conditions. As a neonate is unable to provide their consent regarding participation in research studies, a substitute decision maker (SDM) must provide parental or legal guardian consent. However it has been well documented that there are many emotional, mental and physical challenges associated with the parental consent process in the neonatal intensive care unit (NICU). It is proposed that a flexible parental engaged consent model could help alleviate some of these issues by providing parents with the ability to choose and change their clinical engagement level preference for their infant’s participation in research at their convenience at any point in time. In this paper, an extension to Service based Multidimensional Temporal Data Mining Framework (STDMn0) to allow for the functionality of flexible patient or surrogate consent is presented based on the use of a flexible consent model initially proposed by Heath [1]. This functionality is demonstrated via an example implementation for a generic retrospective research study in the NICU setting.