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CITI Certification Test Questions and Answers (2022/2023) (Verified Answers) $10.99   Add to cart

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CITI Certification Test Questions and Answers (2022/2023) (Verified Answers)

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CITI Certification Test Questions and Answers (2022/2023) (Verified Answers)

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  • November 9, 2022
  • 20
  • 2022/2023
  • Exam (elaborations)
  • Questions & answers
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CITI Certification Test Questions and Answers


1. Belmont Report and its principles:

2. 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 thestudy has a maximization of the benefits and a minimization
of risks

3. Which of the following are the three principles discussed in the Belmont
Report?: Answer-respect for persons, beneficence, justice

4. 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:: Answer-persons with diminished
autonomy areentitled to protection

5. History and ethics of human subjects research:

6. Which of the following brought increased public attention to the problems
with the IRB system?: Answer-Death of Research Subject (Jesse Gelsinger)

7. Informed consent is considered an application of which Belmont princi-
ple?: respect for persons

8. The National Research Act of 1974: Answer-Established the National
Commission

9. Which of the following was the result of the Beecher article?: Answer-
Realizationthat ethical abuses are not limited to the Nazi regime

10. Which of the following is included in the Nuremberg Code:: Answer-


,voluntaryconsent

11. Research involving prisoners:

12. 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.

13. 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

14. 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






, 15. 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.

16. IRB continuing review of a greater than minimal risk approved protocol
that is currently enrolling subjects must:: Occur at least annually

17. Basic institutional review board regulations and review procedures:

18. A general requirement for the informed consent form is that it may not in-
clude 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.

19. 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 inves-
tigator?: 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.

20. An investigator is confronted with a life-threatening situation that ne-

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