CITI Training Exam Questions and
Answers14
Belmont Report and its principles - ANSWERS-
Which of the following is an example of how the principle of beneficence can be applied to a
study employing human subjects? - ANSWERS-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? - ANSWERS-
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: -
ANSWERS-persons with diminished autonomy are entitled to protection
History and ethics of human subjects research - ANSWERS-
Which of the following brought increased public attention to the problems with the IRB system?
- ANSWERS-Death of Research Subject (Jesse Gelsinger)
Informed consent is considered an application of which Belmont principle? - ANSWERS-respect
for persons
The National Research Act of 1974 - ANSWERS-Established the National Commission
, Which of the following was the result of the Beecher article? - ANSWERS-Realization that ethical
abuses are not limited to the Nazi regime
Which of the following is included in the Nuremberg Code: - ANSWERS-voluntary consent
Research involving prisoners - ANSWERS-
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? - ANSWERS-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? - ANSWERS-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? - ANSWERS-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: -
ANSWERS-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: - ANSWERS-Occur at least annually
Basic institutional review board regulations and review procedures - ANSWERS-
Answers14
Belmont Report and its principles - ANSWERS-
Which of the following is an example of how the principle of beneficence can be applied to a
study employing human subjects? - ANSWERS-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? - ANSWERS-
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: -
ANSWERS-persons with diminished autonomy are entitled to protection
History and ethics of human subjects research - ANSWERS-
Which of the following brought increased public attention to the problems with the IRB system?
- ANSWERS-Death of Research Subject (Jesse Gelsinger)
Informed consent is considered an application of which Belmont principle? - ANSWERS-respect
for persons
The National Research Act of 1974 - ANSWERS-Established the National Commission
, Which of the following was the result of the Beecher article? - ANSWERS-Realization that ethical
abuses are not limited to the Nazi regime
Which of the following is included in the Nuremberg Code: - ANSWERS-voluntary consent
Research involving prisoners - ANSWERS-
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? - ANSWERS-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? - ANSWERS-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? - ANSWERS-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: -
ANSWERS-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: - ANSWERS-Occur at least annually
Basic institutional review board regulations and review procedures - ANSWERS-
