Clinical Research CoordinatorCourse 4 of 8

Clinical Research Coordinator

Full course · Informed Consent in Practice

Short-Form Consent and Consent in Emergency Situations — Informed Consent in Practice

Short-Form Consent and Consent in Emergency Situations

Covers the short-form consent process under 21 CFR 50.27(b) including the impartial witness role, and the emergency consent exception under ICH E6(R3) Section 2.8.8 with its conditions and documentation requirements.

22 min

Two situations where the standard consent process cannot proceed

The previous three lessons in this module addressed populations where the challenge was the participant's capacity -- the child who cannot consent independently, the adult whose cognition is impaired, the participant whose decisions must be made or supported by a legally authorized representative. In each case, the standard consent document existed. The question was who could sign it and under what conditions.

This lesson addresses a different category of challenge entirely. Here, the question is not who can consent but whether the standard consent process can happen at all. Two situations push past the boundaries of the ordinary process: when the participant cannot read the consent document in the language in which it was written, and when there is no time to obtain consent before a life-saving intervention must begin.

Both situations have regulatory solutions. The short-form consent process, codified in 21 CFR 50.27(b), addresses the first. The emergency consent exception, outlined in ICH E6(R3) Section 2.8.8 and further specified in FDA regulations at 21 CFR 50.24, addresses the second. And both solutions are, in my experience, among the most frequently misunderstood mechanisms in the informed consent landscape. I have reviewed audit findings and inspection reports where sites used the short-form process as a convenience shortcut, and where emergency consent exceptions were invoked without the pre-approval infrastructure the regulation requires.

These are exception mechanisms -- safety valves built into the regulatory system for situations the standard process was not designed to handle. They are not shortcuts. They are not workarounds. They carry their own documentation requirements that are, if anything, more demanding than the standard process. This lesson will teach you when to use them, how to execute them correctly, and why the details matter.

What you will learn4 objectives

By the end of this lesson, you will be able to:

Describe the short-form consent process under 21 CFR 50.27(b), including the role of the impartial witness, the written summary, and the documentation requirements
Distinguish appropriate uses of the short-form process (unexpected language barriers) from inappropriate ones (convenience, time pressure, routine multilingual enrollment)
Describe the emergency consent exception under ICH E6(R3) Section 2.8.8, including the conditions that must be met and the IRB pre-approval requirements
Execute the documentation requirements for both short-form consent and emergency consent exceptions, including post-emergency consent acquisition

Progress saves itself — finish reading and this lesson completes

This is just the beginning

Two situations where the standard consent process cannot proceed