In 2016, MDIC published the Blueprint for Early Feasibility Study Success, a best practices guide for navigating Early Feasibility Study (EFS) complexities, including regulatory, ethical and legal considerations. Developed as a supplement to the FDA’s Guidance on EFS/FIH Investigational Devices, the EFS Blueprint addressed topics including FDA interactions, Ethics Committees and/or Institutional Review Boards (IRB)s, legal considerations, and patient perspectives. Click this link to navigate to the entire MDIC 2016 Blueprint for Early Feasibility Study Success.
EFS Informed Consent Form Template:
A template of a patient Informed Consent Form (ICF) for adult patients considering participation in a study being conducted under an IDE through the FDA’s EFS Program was developed as part of the 2016 Blueprint for Early Feasibility Study Success.
An updated (JUN-2018) ICF template and editable version (MS Word) of that ICF template for EFS trials can be found here: EFS patient Informed Consent Form template
EFS Background Information: Patients
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. Click this link to navigate to the Patient Introduction to Consent for Early Feasibility Studies
EFS Background Information: IRBs and Site Study Staff
When hospital administration, research staff and IRB members have a good understanding of EFS, the time to complete study contracts, IRB approvals and patient screening and enrollment are likely to decrease. To aid with the education of these stakeholders, a brief “Background Information on Early Feasibility Studies” has been created. This document is directed to patient advocates and describes what it means for a patient to participate in an EFS. Click this link to navigate to the Background Information on Early Feasibility Studies