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?
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.

Answer 1

Answer:yes send a copy of their formed consent via facsimile To the subject's wife and after she has had an opportunity to speak to the investigator, she can sign the informed consent and send it back to you.

Explanation: the man should not be exempted from the trail because his wife is not around to sign up the consent form. Faxing it is a better and quicker way to get the wife's consent because this trial may help her husband. And also a waver of consent will not also be given by the IRB and verbal approval by the wife is not acceptable legally. The best way is still faxing it to the wife and she has done her own background check she can sign it and fax it back via facsimile also.