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