Concepts in Emergency Research Exception from Informed Consent

Concepts in Emergency Research Exception from Informed Consent
Book Chapter
Christine S. Cocanour, Isabelle A. Struve
The Acute Management of Surgical Disease, 16 September 2022; pp 113–123 [Springer]
Abstract
Informed consent is an ethical concept, codified in the law, and is in daily practice at every healthcare institution. It is the process of communication between patients and treating physicians that results in an agreement that allows the treating physician to perform a specific medical intervention. A valid informed consent requires disclosure, capacity, and voluntariness. In the emergency setting this consent process is not possible. Ethical concerns involving subjects who cannot provide consent was a barricade to emergency research. Standard, accepted medical therapy was not tested for either safety or efficacy in the emergency setting. In recognition of this potential harm, the government eventually permitted exception from informed consent in certain emergency research trials in order to (1) provide individuals in life-threatening situations access to potentially life-saving therapies, (2) advance knowledge through collection of information about effectiveness and safety, and (3) improve therapies used in emergency medical situations that currently have poor clinical outcomes. This chapter will explore the history behind informed consent, informed consent for human subject research, and exception from informed consent (EFIC)/waiver of informed consent (WIC).