The German Medical Informatics Initiative Broad Consent in the Emergency Department: A Single Centre Prospective Observational Study to Assess Consenting Mode Dependent Success Rates (Preprint)

Abstract

The Broad Consent (BC) by the German Medical Informatics Initiative (MII) was developed to serve as a national blueprint for consenting patients for the use of routinely collected medical-, insurance- and contact data and biomaterials for research purposes, ensuring compliance with European General Data Protection Regulation (GDPR). Emergency departments (EDs) are characterized by a broad and unselected patient population that provides the opportunity to include patients from different demographic and socioeconomic groups, as well as from different disease groups. While also posing regulatory and ethical challenges, obtaining BC in an ED environment presents a promising opportunity to increase the availability of ED data for research.