November 19, 2018

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:IRBs and Site Study Staff” has been created. This document describes points to consider when contemplating enrolling patients in early feasibility studies. It describes what an early feasibility study is and what participation means to the patient. It also discusses what types of studies and options there are under EFS and safeguards to put in place for patient protection.