What should an investigator do if an elderly gentleman's legally authorized representative is unavailable, but he has shown interest and assent for clinical trial participation?

The focus of this scenario revolves around the informed consent process and the ethical considerations involved in enrolling subjects in clinical trials, particularly those who may not be able to provide consent themselves due to age or other factors.

In this case, the elderly gentleman has shown interest and expressed assent for participation in the clinical trial, which is an important factor; however, it is equally important to ensure that there is proper consent from a legally authorized representative, particularly in vulnerable populations like the elderly. By sending a copy of the informed consent via facsimile to the subject's wife, the investigator is taking steps to involve the legally authorized representative in the consent process. This aligns with ethical guidelines and regulations that require consent to be obtained from the legal representative before proceeding with the participation of an individual who cannot provide direct consent themselves.

This approach also demonstrates respect for the autonomy of the subject as well as adherence to ethical research practices that prioritize the involvement of caregivers or representatives when it comes to making decisions about participation in research trials. It acknowledges both the subject's expressed interest in participating and the necessary legal compliance required when the authorized representative is not present.

Other choices present actions that do not align with ethical standards in clinical research. Excluding the gentleman from the study could overlook the possibility