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.
The correct answer and explanation is:
Correct Answer:
The elderly gentleman cannot enroll in the clinical trial until his legally authorized representative (LAR), his wife, provides informed consent on his behalf.
Explanation:
Informed consent is a fundamental ethical and legal requirement for participation in clinical research. Since the elderly gentleman’s wife is his legally authorized representative (LAR) due to his past strokes, she has the legal authority to make medical decisions for him. Even though he expresses interest and shows basic understanding, his ability to provide fully informed consent is legally compromised, meaning his LAR must give permission before he can be enrolled in the trial.
Key Ethical and Legal Considerations:
- Legally Authorized Representative (LAR):
- Since the subject’s wife is designated as his LAR, she is the only one who can legally provide consent for his participation.
- Without her explicit approval, enrolling him in the trial would violate ethical research guidelines and legal requirements.
- Assent vs. Consent:
- Assent means the patient agrees to participate but does not have full legal capacity to provide informed consent.
- Consent must be provided by the LAR to ensure the decision aligns with the patient’s best interests.
- Clinical Research Ethics (Belmont Report & Common Rule):
- The Belmont Report outlines the principles of respect for persons, beneficence, and justice in research.
- The Common Rule (45 CFR 46) requires that subjects who lack full decision-making capacity must have an LAR provide consent.
- Next Steps:
- The research team must wait until the wife returns or contact her remotely to obtain informed consent.
- Once consent is obtained, the elderly gentleman can officially enroll in the trial.
Since the wife is unavailable, the trial enrollment must be postponed until she provides legal consent.
Here is the image illustrating the elderly gentleman in a doctor’s office, engaging in a discussion about the clinical trial. Let me know if you need any modifications or additional details!
