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Question 1
Question :
An elderly gentleman, whose wife is his legally authorized representative since his strokes several years ago, was recently diagnosed with lung cancer. He is eligible for a clinical trial using a new investigational drug that aims to treat lung cancer. He is able to express interest, shows a basic understanding of the nature of the trial, and gives his assent to participation. The subject's wife is out of town on a business trip.

Which of the following is the most appropriate action to take for the investigator?

Your answer : The investigator can go ahead and enroll the man without a signed consent.
Correct Answer : Send a copy of the informed consent via facsimile to the subject's wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back.
Comment :
The IRB will not provide a waiver of consent under these circumstances and the man should not be excluded from the study simply because his legally authorized representative is temporarily unavailable to sign in person. Verbal approval does not satisfy the FDA requirement at 21 CFR 56.109(c) of signed informed consent document. When obtaining consent from a legally authorized representative (LAR) who is not able to provide signed consent in person, it is acceptable to send the informed consent document to the LAR by facsimile and conduct the consent interview by telephone when the LAR can read the consent as it is discussed as noted in the FDA's FAQs. If the LAR agrees, he/she can sign the consent and return the signed document to the clinical investigator by facsimile.
Points Earned : 0
Question 2
Question :
A general requirement for the informed consent is that no informed