UMEM Educational Pearls

Title: Emergency Care Research: What is the difference between waiver versus exception for informed consent?

Keywords: Research, ethics, informed consent (PubMed Search)

Posted: 4/21/2016 by Jon Mark Hirshon, PhD, MPH, MD
Click here to contact Jon Mark Hirshon, PhD, MPH, MD

The terms and concepts of “waiver of informed consent’ versus “exception from informed consent” are often confused. Within the U.S., these concepts are not the same.

Waiver or alteration of informed consent is for minimal risk research and requires the following 4 conditions:
- Research involves no more than minimal risk to the subjects;
- Waiver or alteration will not adversely affect the rights and welfare of the subjects;
- Research could not practicably be carried out without the waiver or alteration; and
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation

Exception from informed consent (EFIC) is permissible for emergency research:
- Rarely used, only for true emergencies
- Recognition that there are times/conditions when informed consent is not feasible
  - Length of potential therapeutic window is defined (i.e.- short window)
- Must hold the potential for direct benefit for the subject
- Requires special protections and conditions, in addition to the regular ethical review
  - Including a community consultation process

Bottom line:

Waiver of Informed Consent ≠ EFIC

Exception from informed consent (EFIC) is rarely used and is only for true, life threatening situations. It requires substantial review and special steps to obtain.
Waiver of informed consent is commonly used for retrospective chart reviews and similar minimal risk research.

These are the rules and regulations for the U.S. The regulations for emergency research in other countries may or may not be similar to these.

References

45 CFR 46.116(d)

21 CFR 50.24 and 45 CFR 46.101