RM: CITI Module Quizzes AND 74 Complete Solutions 100%
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Course
CITI
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CITI
RM: CITI Module Quizzes AND 74 Complete Solutions 100%
RM: CITI Module Quizzes AND 74 Complete Solutions 100%
RM: CITI Module Quizzes AND 74 Complete Solutions 100%
RM: CITI Module Quizzes AND 74 Complete Solutions 100%
RM: CITI Module Quizzes AND 74 Complete Solutions 100%
RM: CITI Module Qui...
RM: CITI Module Quizzes AND 74
Complete Solutions.
RM: CITI Module Quizzes AND 74
Complete Solutions.
Which of the following are the three principles discussed in the Belmont Report? -
Answer = Respect for Persons, Beneficence, Justice.
Which of the following is an example of how the Principle of Beneficence can be applied
to a study employing human subjects? - Answer = Determining that the study has a
maximization of benefits and a minimization of risks.
All of the following are true regarding the Belmont Report, EXCEPT: - Answer = The
Belmont Report indicates that it is necessary to rigorously avoid conflicts of interest.
Which of the following brought increased public attention to the problems with the IRB
system? - Answer = Death of Jesse Gelsinger
Issued in 1974, 45 CFR 46 raised to regulatory status: - Answer = US Public Health
Service Policy
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
Informed consent is considered an application of which Belmont principle? - Answer =
Respect for Persons
Which of the following was the result of the Beecher article? - Answer = Realization that
ethical abuses are not limited to the Nazi regime
The National Research Act of 1974 - Answer = Established the National Commission.
Which of the following is included in the Nuremberg Code: - Answer = Voluntary
consent
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? - 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.
, RM: CITI Module Quizzes AND 74
Complete Solutions.
How long is an investigator required to keep consent documents, IRB correspondence,
and research records? - Answer = 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? - Answer = The study
involves no more than minimal risk and 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
and well being of the subject.
IRB continuing review of an approved protocol must: - Answer = Occur at least annually.
The purpose of informed consent is: - Answer = To provide a potential subject with
appropriate information in an appropriate manner and allow that person to make an
informed decision about participation in research.
An elderly gentleman, whose wife is his legally authorized representative since his
strokes several years ago, was recently diagnosed with lung cancer. He is eligible for a
clinical trial using a new investigational drug that aims to treat lung cancer. He is able to
express interest, shows a basic understanding of the nature of the trial, and gives his
assent to participation. The subject's wife 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, she can sign the informed
consent and fax it back.
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.
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 recognized therapy is available. Under the FDA regulations for using test
articles, which of the following describes the best course of action for the investigator: -
Answer = The investigator and an independent physician agree that the situation
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