RM: Citi Modules Exam 2026 Questions
and 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
The use of prisoners in research is a concern under the *Belmont principle of
Justice* because: - Correct Answer -Prisoners may be used to conduct research that
only benefits the larger society
Issued in 1974, 45 CFR 46 raised to regulatory status: - Correct Answer -US Public
Health Service Policy (45 CFR 46 raised to regulatory status the US Public Health
Service policy of 1966 "Clinical research and investigation involving human
beings".)
Which of the following brought increased public attention to the problems with the
IRB system? - Correct Answer -Death of Jesse Gelsinger (Although all of these are
related to the problems with the IRB system, the death of Jesse Gelsinger was what
received public attention.)
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, Which of the following is included in the Nuremberg Code? - Correct Answer -
Voluntary Consent
Informed consent is considered an application of which Belmont principle? **** -
Correct Answer -Respect for Persons (Respect for persons involves respecting
individual autonomy in the decision to participate in research. That respect is
implemented through the process of informed consent)
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 & research records? - Correct Answer -For a *minimum of three
years* after completion of the study. (May be required to keep them longer than 3
years)
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 & meets one of the
allowable categories of expedited review specified in federal regulations.
©COPYRIGHT 2025 ALL RIGHTS RESERVED 2
and 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
The use of prisoners in research is a concern under the *Belmont principle of
Justice* because: - Correct Answer -Prisoners may be used to conduct research that
only benefits the larger society
Issued in 1974, 45 CFR 46 raised to regulatory status: - Correct Answer -US Public
Health Service Policy (45 CFR 46 raised to regulatory status the US Public Health
Service policy of 1966 "Clinical research and investigation involving human
beings".)
Which of the following brought increased public attention to the problems with the
IRB system? - Correct Answer -Death of Jesse Gelsinger (Although all of these are
related to the problems with the IRB system, the death of Jesse Gelsinger was what
received public attention.)
©COPYRIGHT 2025 ALL RIGHTS RESERVED 1
, Which of the following is included in the Nuremberg Code? - Correct Answer -
Voluntary Consent
Informed consent is considered an application of which Belmont principle? **** -
Correct Answer -Respect for Persons (Respect for persons involves respecting
individual autonomy in the decision to participate in research. That respect is
implemented through the process of informed consent)
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 & research records? - Correct Answer -For a *minimum of three
years* after completion of the study. (May be required to keep them longer than 3
years)
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 & meets one of the
allowable categories of expedited review specified in federal regulations.
©COPYRIGHT 2025 ALL RIGHTS RESERVED 2
