Question

An elderly gentleman, whose wife is his legally authorized representative (LAR) 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. The investigator can go ahead and enroll the man without a signed consent. Consult a colleague about his opinion. If the colleague agrees, enroll the man without a signed consent. Exclude the man from the study.

Answer 1

- 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.

Step-by-step explanation:

• A legally authorized representative has the duty to take part in making key decisions in the individual he or she represents.
• In the above case, the cure trial using a newly discovered medicine is a very sensitive decision that need the incorporation and authority from the legally authorized representative.
• Therefor, there have to be crafted mechanisms to get the official authorization that is signed from the man's wife.
• Sending a copy of informed consent over facsimile, and her sending back a signed copy through fax makes it official that she has granted authority for the process.