[Answer] An investigator wishes to utilize an FDA-unapproved drug to treat a patient for whom there is no standard acceptable treatment. There is no IRB-approved protocol available for use of this drug. Which of the following is true?

Answer: The patient must be in a life-threatening or severely debilitating situation which necessitates the use of the investigational drug. - In an emergency use situation the FDA permits an exemption from prior review and approval by an IRB. Emergency use is the use of an investigational drug or device with a human subject in a life-threatening situation and in which no standard acceptable treatment is available and there is not sufficient time to obtain IRB approval. Subsequent use of the investigational product at the institution must have prospective IRB review and approval. If the investigator wishes to use the data for research purposes IRB review and approval is required in all circumstances.

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An investigator wishes to utilize an FDA-unapproved drug to treat a patient for whom there is no standard acceptable...

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