Did you know that the FDA actually has an “Exception From Informed Consent”?
It’s called EFIC, codified at 21 CFR §50.24, and it allows researchers to enroll people in certain emergency clinical trials without getting their permission first.
If you’re unconscious, critically injured, seizing, bleeding out, or otherwise unable to consent, you can be randomized into a study and given an experimental drug, blood product, procedure, or device before you or your family ever agree to it.
The justification is that some emergency research would be impossible if doctors had to wait for consent.