An elderly man recently diagnosed with lung cancer is screened for a clinical trial using a new investigational drug. The investigator has carefully explained all of the required information about the study to the subject and the subject’s daughter. The subject demonstrates his understanding and willingness to participate, but is not able to sign the informed consent document due to paralysis from a swimming accident years before. The subject’s wife is his legally authorized representative, but she is out of town on a business trip. Which of the following is the most appropriate action to take for the investigator?
a. The investigator can go ahead and treat the man without a signed consent since he verbally agreed to participate.
b. 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 and her husband, she can sign the informed consent and fax it back.
c. Exclude the man from the study.
d. Request the IRB waive the requirement for a signed informed consent.