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?
Exclude the man from the study.
Consult a colleague about his opinion. If the colleague agrees, enroll the man without a signed consent.
The investigator can go ahead and enroll the man without a signed consent.
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 Correct Answer and Explanation is:
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.
Explanation:
Informed consent is a foundational ethical and legal requirement in clinical research, particularly when dealing with vulnerable populations such as elderly individuals with cognitive impairments. In this scenario, although the elderly man expresses interest and can assent to participation, he has a legally authorized representative (LAR)—his wife—due to prior strokes that have likely impacted his capacity to give fully informed consent. According to ethical research standards and U.S. federal regulations (e.g., 45 CFR 46, known as the Common Rule), when a participant lacks full decisional capacity, informed consent must be obtained from the LAR.
However, the man is not entirely incapable—he can provide assent, which means he is willing to participate and shows some understanding. This is important ethically because the participant’s wishes still matter, even when a surrogate decision-maker is required. But assent alone is not legally sufficient to enroll him in a clinical trial when he has an LAR.
The most appropriate action is to send the informed consent form to the LAR (his wife), ensuring she has ample opportunity to review the document, speak with the investigator, ask questions, and make an informed decision on behalf of her husband. Faxing (or secure electronic transmission) and returning a signed copy is permissible and commonly practiced, especially when the LAR is not physically present.
The other choices are inappropriate:
- Excluding the man unnecessarily denies him a potentially beneficial treatment.
- Consulting a colleague does not substitute for legally valid consent.
- Enrolling without consent violates ethical standards and federal regulations.
Thus, proper documentation and communication with the LAR ensure both ethical integrity and compliance with regulatory standards.