citi exam 3 questions and answers2
The purpose of informed consent is: - ANSWERS-To provide a potential subject with appropriate
information in an appropriate manner and allow that person to make an informed decision
about participation in research.
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? - ANSWERS-
Send a copy of the informed consent via facsimile to the subject's wife. After she has had the
opportunity to speak to the investigator, she can sign the informed consent and fax it back.
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: - ANSWERS-The investigator
and an independent physician agree that the situation necessitates the use of the test article.
An exception or waiver for informed consent can be made under these circumstances. The IRB
will be notified later.
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?
- ANSWERS-Give the subject comprehensive information about the new drug, including its side
effects. 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.
The purpose of informed consent is: - ANSWERS-To provide a potential subject with appropriate
information in an appropriate manner and allow that person to make an informed decision
about participation in research.
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? - ANSWERS-
Send a copy of the informed consent via facsimile to the subject's wife. After she has had the
opportunity to speak to the investigator, she can sign the informed consent and fax it back.
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: - ANSWERS-The investigator
and an independent physician agree that the situation necessitates the use of the test article.
An exception or waiver for informed consent can be made under these circumstances. The IRB
will be notified later.
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?
- ANSWERS-Give the subject comprehensive information about the new drug, including its side
effects. 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.
