Assignment:
You are conducting a randomized clinical trial to evaluate a new chemotherapy regimen for treatment of inoperable non-small-cell lung cancer. Patients with inoperable lung cancer will be randomized to the new regimen or no active care. It is hoped that the new regimen will improve disease-free survival and overall survival.
- What evidence will the Committee on Human Subjects (IRB) require before approving your protocol?
- What training would you provide to the people obtaining informed consent?
- What material should be included in the informed consent form?
Your answer must be typed, double-spaced, Times New Roman font (size 12), one-inch margins on all sides, APA format.