CITI Training, Questions with accurate answers, 100% verified. Rated A
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CITI Training, Questions with accurate answers, 100% verified. Rated A
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 b...
CITI Training, Questions with accurate
answers, 100% verified. Rated A
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
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