CITI Training Questions With All Correct Answers
Which of the following was the result of the Beecher article? correct answer
-Realization that ethical abuses are not limited to the Nazi regime
Issued in 1974, 45 CFR 46 raised to regulatory status: correct answer -US
Public Health Service Policy
The use of prisoners in research is a concern under the Belmont principle of
Justice because: correct answer -Prisoners may not be used to conduct
research that only benefits the larger society
Which of the following is included in the Nuremberg Code: correct answer
-Voluntary consent
Which of the following brought increased public attention to the problems
with the IRB system? correct answer -Death of Research Subject (Jesse
Gelsinger)
A subject in a clinical research trial experiences a serious, unanticipated
adverse drug experience. How should the investigator proceed, with respect
to the IRB, after the discovery of the adverse event occurrence? correct
answer -Report the adverse drug experience in a timely manner, in keeping
with the IRB's policies and procedures, using the forms or the mechanism
provided by the IRB.
How long is an investigator required to keep consent documents, IRB
correspondence, and research records? correct answer -For a minimum of
three years after completion of the study
According to federal regulations, which of the following best describes when
expedited review of a new, proposed study may be used by the IRB? correct
answer -The study involves no more than minimal risk and meets one of the
allowable categories of expedited review specified in federal regulations
Amendments involving changes to IRB-approved protocols do NOT need prior
IRB approval if: correct answer -The changes must be immediately
implemented for the health and well-being of the subject.
, IRB continuing review of a greater than minimal risk approved protocol that is
currently enrolling subjects must: correct answer -Occur at least annually.
An elderly gentleman, whose wife is his legally authorized representative
(LAR) 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. correct answer -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
LAR 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: correct answer -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? correct answer -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.
A general requirement for the informed consent form is that it may not
include any exculpatory language. Exculpatory language is that which waives
or appears to waive any of the subject's legal rights or releases or appears to
release those conducting the research from liability for negligence. Which of
the following statements in a consent form is an example of exculpatory
language? correct answer -I waive any possibility of compensation for
injuries that I may receive as a result of participation in this research.
Which of the following was the result of the Beecher article? correct answer
-Realization that ethical abuses are not limited to the Nazi regime
Issued in 1974, 45 CFR 46 raised to regulatory status: correct answer -US
Public Health Service Policy
The use of prisoners in research is a concern under the Belmont principle of
Justice because: correct answer -Prisoners may not be used to conduct
research that only benefits the larger society
Which of the following is included in the Nuremberg Code: correct answer
-Voluntary consent
Which of the following brought increased public attention to the problems
with the IRB system? correct answer -Death of Research Subject (Jesse
Gelsinger)
A subject in a clinical research trial experiences a serious, unanticipated
adverse drug experience. How should the investigator proceed, with respect
to the IRB, after the discovery of the adverse event occurrence? correct
answer -Report the adverse drug experience in a timely manner, in keeping
with the IRB's policies and procedures, using the forms or the mechanism
provided by the IRB.
How long is an investigator required to keep consent documents, IRB
correspondence, and research records? correct answer -For a minimum of
three years after completion of the study
According to federal regulations, which of the following best describes when
expedited review of a new, proposed study may be used by the IRB? correct
answer -The study involves no more than minimal risk and meets one of the
allowable categories of expedited review specified in federal regulations
Amendments involving changes to IRB-approved protocols do NOT need prior
IRB approval if: correct answer -The changes must be immediately
implemented for the health and well-being of the subject.
, IRB continuing review of a greater than minimal risk approved protocol that is
currently enrolling subjects must: correct answer -Occur at least annually.
An elderly gentleman, whose wife is his legally authorized representative
(LAR) 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. correct answer -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
LAR 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: correct answer -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? correct answer -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.
A general requirement for the informed consent form is that it may not
include any exculpatory language. Exculpatory language is that which waives
or appears to waive any of the subject's legal rights or releases or appears to
release those conducting the research from liability for negligence. Which of
the following statements in a consent form is an example of exculpatory
language? correct answer -I waive any possibility of compensation for
injuries that I may receive as a result of participation in this research.
