CITI Exam (LATEST 2022) VERIFIED Questions
and Answers
Which of the following is included in the Nuremberg Code: - voluntary consent
The National Research Act of 1974 - Established the National Commission.
Informed consent is considered an application of which Belmont principle? - Respect for Persons
Issued in 1974, 45 CFR 46 raised to regulatory status: - US Public Health Service Policy
Which of the following brought increased public attention to the problems with the IRB system? -
Death of Jesse Gelsinger
The use of prisoners in research is a concern under the Belmont principle of Justice because: -
Prisoners may be used to conduct research that only benefits the larger society
Which of the following was the result of the Beecher article? - Realization that ethical abuses are
not limited to the Nazi regime
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? - 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? - 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? - The study involves no more than minimal risk and
meets one of the allowable categories of expedited review specified in federal regulations
and Answers
Which of the following is included in the Nuremberg Code: - voluntary consent
The National Research Act of 1974 - Established the National Commission.
Informed consent is considered an application of which Belmont principle? - Respect for Persons
Issued in 1974, 45 CFR 46 raised to regulatory status: - US Public Health Service Policy
Which of the following brought increased public attention to the problems with the IRB system? -
Death of Jesse Gelsinger
The use of prisoners in research is a concern under the Belmont principle of Justice because: -
Prisoners may be used to conduct research that only benefits the larger society
Which of the following was the result of the Beecher article? - Realization that ethical abuses are
not limited to the Nazi regime
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? - 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? - 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? - The study involves no more than minimal risk and
meets one of the allowable categories of expedited review specified in federal regulations
