Model Operational Procedures for the Implementation and Review of NIH Sponsored Multicenter Clinical Trials with Exception from Informed Consent (EFIC) for Emergency Research

Model Operational Procedures for the Implementation and Review of NIH Sponsored Multicenter Clinical Trials with Exception from Informed Consent (EFIC) for Emergency Research
SIREN Clinical Coordinating Center
Version 1, January 2021
Open Access
Introduction
    The purpose of this document is to provide a model process and procedures that can be used as starting point for implementation of clinical trials using Exception from Informed Consent for Emergency Research (EFIC) in NIH funded multicenter clinical trials. The process and procedures described can and must be adapted to the specific needs and details of any future trials. The materials provided were developed and informed by both thorough review of the accumulated scholarship related to EFIC, and other lessons learned through practical shared experiences of prior NIH funded emergency care researchers.
This document is intended to be a useful, practical, and tested peer-to-peer tool for future investigators in this field. It is not intended to be a definitive guideline for application of the EFIC regulations, and should NOT be interpreted as any form of regulatory guidance. Regulatory guidance is available from FDA. This document does not represent the only way to implement Exception from Informed Consent, and may not be applicable or optimal for EFIC studies that differ from those for which this document was created. This document is intended to be open access, and shared through a Creative Commons Attribution-NonCommercial (CC BY-NC) license that lets others adapt, and build upon the work non-commercially. New works must acknowledge the source materials and the NIH and be non-commercial. The derivative works do not have be licensed on the same terms.

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