RM: Citi Modules Exam 2024 | Citi
Modules RM Exam Update 2024-2025
Questions and Correct Answers Rated
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Which of the following was the result of the Beecher article? -
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: -ANSWER-Prisoners may be used to
conduct research that only benefits the larger society
Issued in 1974, 45 CFR 46 raised to regulatory status: -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? -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? -
ANSWER-Voluntary Consent
Informed consent is considered an application of which Belmont
principle? **** -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? -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? -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? -ANSWER-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: -ANSWER-The changes must be
immediately implemented for the health & well being of the subject.
IRB continuing review of an approved protocol must: -ANSWER-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? -ANSWER-Give the subject comprehensive information
, about the new drug, including its side effects. Discuss the pros and
cons of both the investigational drug and the commercially available
drug and then allow the subject to decide whether to withdraw from
the research to take the new drug.
A general requirement for the informed consent is that no informed
consent may include any exculpatory language. Exculpatory language
is that which waives or appears to waive any of the subject's legal
rights or releases or appears to release those conducting the research
from liability for negligence. Which of the following statements in a
consent form is an example of exculpatory language? -ANSWER-I
waive any possibility of compensation for injuries that I may receive as
a result of participation in this research.
A man in his early 50s, who was recently diagnosed with lung cancer,
is screened for a clinical trial using a new investigational drug. The
investigator has carefully explained all of the required information
about the study to the subject and the subject's daughter. The subject
demonstrates his understanding and willingness to participate, but is
not able to sign or mark the informed consent document due to a
recent accident where he burned both hands. The subject's wife is his
legally authorized representative, but she is out of town on a business
trip. Which of the following is the most appropriate action to take for
the investigator? -ANSWER-Send a copy of the informed consent via
facsimile to the subject's wife. After she has had the opportunity to
speak to the investigator and her husband, she can sign the informed
consent and fax it back.
An investigator is confronted with a life-threatening situation that
necessitates using a test article in a human subject who is unable to
provide informed consent and there is no time to obtain consent from
the individual's legal representative and no alternative method or
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