RM: Citi Modules with 24 quiz and
correct answers.
RM: Citi Modules with 24 quiz and
correct 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.)
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)
correct answers.
RM: Citi Modules with 24 quiz and
correct 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.)
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)
