Patient Introduction to Consent for Early Feasibility Studies

To aid with the education of patients who may be eligible for a specific EFS, a brief “Introduction to Consent for Early Feasibility Studies for Patients” has been created specifically to address questions and needs patients might have in enrolling to EFS studies. This document focuses specifically on what it means to participate in an EFS. An important aspect of patient advocacy in EFS is to ensure that patients have a good understanding of EFS. The Informed Consent Form (ICF) provides details on EFS, as well as an overview of the risks associated with the specific device and EFS trial. The “Introduction to Consent for Early Feasibility Studies for Patients” is an educational aid provided to the patient prior to presentation of the ICF.