An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent from the individual’s LAR and no alternative method or recognized therapy is available. Under the FDA regulations for using test articles, which of the following describes the best course of action for the investigator:
Do not use the test article until either the subject or the subject’s LAR can give consent.
Use the test article without obtaining consent from the subject or the LAR then notify the IRB.
Submit a research protocol to the IRB and justify an expedited review approval of the consent document so test article can be used immediately.
The investigator and an independent physician agree that the situation necessitates the usè ?of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later.