An investigator is confronted with a life-threaten...

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Question Number 23

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 for the individual's legal representative. Under the FDA regulations, which of the following describes the best course of action for the investigator:A. Do not use the test article until either the subject or the subject's legally authorized representative can give consent.B. Submit a research protocol to the IRB and justify an expedited review approval of the consent document so the test article can be used immediately.C. The investigator and another physician not part of the study team agree that the situation necessitates the use of the test article and the IRB will be notified later.D. Sign the consent form on behalf of the subject and use the test article.

The investigator and another physician not part of the study team agree that the situation necessitates the use of the test article and the IRB will be notified later.

✔ Correct Answer:

The investigator and another physician not part of the study team agree that the situation necessitates the use of the test article and the IRB will be notified later.

CITI Training Quiz Latest Questions And Answers (Verified Answers)

Question Number 23

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