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Citi exams All Answers Correct Which of the following is included in the Nuremberg Code: Ans- voluntary consent The National Research Act of 1974 Ans- Established the National Commission. Informed consent is considered an application of which Belmont principle? Ans- Respect for Persons Issued i...

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  • March 21, 2023
  • 3
  • 2022/2023
  • Exam (elaborations)
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Citi exams All Answers Correct
Which of the following is included in the Nuremberg Code: Ans- voluntary consent



The National Research Act of 1974 Ans- Established the National Commission.



Informed consent is considered an application of which Belmont principle? Ans- Respect for Persons



Issued in 1974, 45 CFR 46 raised to regulatory status: Ans- US Public Health Service Policy



Which of the following brought increased public attention to the problems with the IRB system? Ans-
Death of Jesse Gelsinger



The use of prisoners in research is a concern under the Belmont principle of Justice because: Ans-
Prisoners may be used to conduct research that only benefits the larger society



Which of the following was the result of the Beecher article? Ans- 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? Ans- 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? Ans- 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? Ans- The study involves no more than minimal risk and meets
one of the allowable categories of expedited review specified in federal regulations

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