Question

A 46-year-old man is currently enrolled in a phase III study of a drug for severe diabetic neuropathy. While the study is ongoing, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?
Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug
waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
The investigator and another physician who is not part of the study team agree that the situation necessitates the use of the test article and the IRB will be notified later.

Answer 1

Answer:

Explanation:

A 46-year-old man is currently enrolled in a phase III study of a drug for severe diabetic neuropathy. While the study is ongoing, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should 1..Give the subject comprehensive information about the new drug, including its side effects.

2..Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug