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CITI Training EXAM 2024 VERIFIED AND PASSED
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CITI Training EXAM 2024 VERIFIED AND PASSED
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CITI Training EXAM 2024 VERIFIEDAND PASSED
Belmont Report and its principles - //
Which of the following is an example of how the principle of
beneficence can be applied to a study employing human
subjects? - //Determining that the study has a maximization of the
benefits and a minimization of risks
Which of the following are the three principles discussed in the
Belmont Report? - //respect for persons, beneficence, justice
The Belmont Report's principle of respect for persons incorporates
at least two ethical convictions: first, that individuals should be
treated as autonomous agents, and second, that: - //persons with
diminished autonomy are entitled to protection
History and ethics of human subjects research - //
Which of the following brought increased public attention to the
problems with the IRB system? - //Death of Research Subject
(Jesse Gelsinger)
Informed consent is considered an application of which Belmont
principle? - //respect for persons
,The National Research Act of 1974 - //Established the National
Commission
Which of the following was the result of the Beecher article? -
//Realization that ethical abuses are not limited to the Nazi regime
Which of the following is included in the Nuremberg Code: -
//voluntary consent
Research involving prisoners - //
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? - //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, and research records? - //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? - //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: - //The changes must be
immediately implemented for the health and well being of the
subject.
IRB continuing review of a greater than minimal risk approved
protocol that is currently enrolling subjects must: - //Occur at least
annually
Basic institutional review board regulations and review
procedures - //
A general requirement for the informed consent form is that it
may not 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? - //I waive any possibility of compensation for injuries
that I may receive as a result of participation in this research.
An elderly gentleman, whose wife is his legally authorized
representative (LAR) 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? - //Send a copy of the informed consent via
facsimile to the subject's wife. After she has had the opportunity
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