EFIC Resources

HOBIT

EFIC Resources

The Exception from Informed Consent (EFIC) Resources page provides critical documents and guidance for sites approved to enroll under EFIC. This section includes the latest protocol version, milestone tracking, regulatory requirements, and best practices for EFIC implementation. Additionally, resources such as the EFIC Review Process, FAQs, and FDA guidance are available to support compliance with EFIC regulations. Explore the materials below to ensure your site meets all EFIC-related requirements.

Protocol v.6 (New 1-5-21) – Only for EFIC-approved sites

Milestone Document

FAQs Regarding EFIC & Advarra as the cIRB

EFIC Plan (cIRB-approved materials in Appendix)

Specific EFIC Considerations During COVID-19

EFIC Forms Resource Guide (Local Context, CC & PD Form – Navigation and Completion in WebDCU)

cIRB-Approved Site EFIC Plans from BOOST-3 (Harborview and UCSF)