RM CITI MODULES – CITI TRAINING STUDY GUIDE, PRACTICE QUESTIONS &
REVIEW 2026/2027
Which of the following was the result of the Beecher article? - ✔✔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: -
✔✔Prisoners may be used to conduct research that only benefits the larger society
Issued in 1974, 45 CFR 46 raised to regulatory status: - ✔✔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? -
✔✔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.)
Which of the following is included in the Nuremberg Code? - ✔✔Voluntary Consent
Informed consent is considered an application of which Belmont principle? **** - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔The study involves no more than minimal risk & 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: - ✔✔The
changes must be immediately implemented for the health & well being of the subject.
IRB continuing review of an approved protocol must: - ✔✔Occur at least annually.
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? - ✔✔Give the subject
comprehensive information about the new drug, including its side effects. Discuss the pros and cons of
REVIEW 2026/2027
Which of the following was the result of the Beecher article? - ✔✔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: -
✔✔Prisoners may be used to conduct research that only benefits the larger society
Issued in 1974, 45 CFR 46 raised to regulatory status: - ✔✔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? -
✔✔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.)
Which of the following is included in the Nuremberg Code? - ✔✔Voluntary Consent
Informed consent is considered an application of which Belmont principle? **** - ✔✔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? - ✔✔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? - ✔✔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? - ✔✔The study involves no more than minimal risk & 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: - ✔✔The
changes must be immediately implemented for the health & well being of the subject.
IRB continuing review of an approved protocol must: - ✔✔Occur at least annually.
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? - ✔✔Give the subject
comprehensive information about the new drug, including its side effects. Discuss the pros and cons of
