Citi Exams Questions And Answers Latest Update With Complete Solution pdf
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.Citi Exams Questions And Answers
Which of the following is included in the Nuremberg Code: - voluntary consent
The National Research Act of 1974 - Established the National Commission.
Informed consent is considered an application of which Belmont principle? - Respect for
Persons
Issued in 1974, 45 CFR 46 raised to regulatory status: - US Public Health Service Policy
Which of the following brought increased public attention to the problems with the IRB
system? - Death of Jesse Gelsinger
The use of prisoners in research is a concern under the Belmont principle of Justice
because: - Prisoners may be used to conduct research that only benefits the larger society
Which of the following was the result of the Beecher article? - Realization that ethical
abuses are not limited to the Nazi regime
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 an approved protocol must: - Occur at least annually.
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: - The investigator and
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