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An elderly gentleman, whose wife is his legally authorized representative 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?
Your answer : The investigator can go ahead and …show more content…
The IRB will be notified later.
The life- threatening situation requires a timely decision so that the test article can be ethically used. It would be unethical to withhold emergency treatment until a research protocol is submitted and approved by the IRB. Not using the test article in a situation where it might save a life is also unethical. The Federal regulations (21 CFR 50.24) provide the option of using the test article in a life-threatening condition involving an individual subject where the following requirements for an exception from informed consent are met. 1. The investigator, with the concurrence of another physician, believes the situation necessitates the use of a test article (i.e., an investigational drug, device, or biologic). 2. The subject and/or legally authorized representative is unable to communicate consent. 3. There is insufficient time to obtain consent. And 4. No alternative exists that will provide an equal or better chance of saving the subject's life.
Points Earned : 0
A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the study is on going, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?
Your answer : Withhold this new information to avoid confusing the subject with other treatment