Evaluating and Extending the Informed Consent Ontology for Representing Permissions from the Clinical Domain.

ABSTRACT: The purpose of this study was to evaluate, revise, and extend the Informed Consent Ontology (ICO) for expressing clinical permissions, including reuse of residual clinical biospecimens and health data. This study followed a formative evaluation design and used a bottom-up modeling approach. Data were collected from the literature on US federal regulations and a study of clinical consent forms. Eleven federal regulations and fifteen permission-sentences from clinical consent forms were iteratively modeled to identify entities and their relationships, followed by community reflection and negotiation based on a series of predetermined evaluation questions. ICO included fifty-two classes and twelve object properties necessary when modeling, demonstrating appropriateness of extending ICO for th

SUBMITTER: Umberfield EE 

PROVIDER: S-EPMC9616177 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature