CITI TRAINING Questions With All Correct Answers
Belmont Report and its principles correct answer -
Which of the following is an example of how the principle of beneficence can
be applied to a study employing human subjects? correct answer -
Determining that the study has a maximization of the benefits and a
minimization of risks
Which of the following are the three principles discussed in the Belmont
Report? correct answer -respect for persons, beneficence, justice
The Belmont Report's principle of respect for persons incorporates at least
two ethical convictions: first, that individuals should be treated as
autonomous agents, and second, that: correct answer -persons with
diminished autonomy are entitled to protection
History and ethics of human subjects research correct answer -
Which of the following brought increased public attention to the problems
with the IRB system? correct answer -Death of Research Subject (Jesse
Gelsinger)
Informed consent is considered an application of which Belmont principle?
correct answer -respect for persons
The National Research Act of 1974 correct answer -Established the
National Commission
Which of the following was the result of the Beecher article? correct answer
-Realization that ethical abuses are not limited to the Nazi regime
Which of the following is included in the Nuremberg Code: correct answer
-voluntary consent
Research involving prisoners correct answer -
, 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
Basic institutional review board regulations and review procedures correct
answer -
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.
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
Belmont Report and its principles correct answer -
Which of the following is an example of how the principle of beneficence can
be applied to a study employing human subjects? correct answer -
Determining that the study has a maximization of the benefits and a
minimization of risks
Which of the following are the three principles discussed in the Belmont
Report? correct answer -respect for persons, beneficence, justice
The Belmont Report's principle of respect for persons incorporates at least
two ethical convictions: first, that individuals should be treated as
autonomous agents, and second, that: correct answer -persons with
diminished autonomy are entitled to protection
History and ethics of human subjects research correct answer -
Which of the following brought increased public attention to the problems
with the IRB system? correct answer -Death of Research Subject (Jesse
Gelsinger)
Informed consent is considered an application of which Belmont principle?
correct answer -respect for persons
The National Research Act of 1974 correct answer -Established the
National Commission
Which of the following was the result of the Beecher article? correct answer
-Realization that ethical abuses are not limited to the Nazi regime
Which of the following is included in the Nuremberg Code: correct answer
-voluntary consent
Research involving prisoners correct answer -
, 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
Basic institutional review board regulations and review procedures correct
answer -
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.
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
