Essay on Quiz Results - Informed Consent

1133 Words Aug 10th, 2016 5 Pages
You correctly answered 1 of 5 and received 1 of 5 possible points.

Scroll down to review the quiz questions and the explanation of the answers.
Question 1
Question :
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
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Which of the following statements in a consent form is an example of exculpatory language?
Your answer : I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
Correct Answer : I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
Comment :
Exculpatory language is written content in the consent document through which the subject is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence. Such language is specifically prohibited.
Points Earned : 1
Question 3
Question :
An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent from the individual’s legal representative and no alternative method or recognized therapy is available. Under the FDA regulations for using test articles, which of the following describes the best course of action for the investigator:
Your answer : Use the test article without obtaining consent from the subject or the legal representative then notify the IRB.
Correct Answer : The investigator and an…