Medical Informatics IRB Exam Questions Correctly Answered.
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Course
IRB.
Institution
IRB.
Medical Informatics IRB Exam Questions Correctly Answered.
Which of the following are the three principles discussed in the Belmont Report? - CORRECT ANSWER Respect for Persons, Beneficence, Justice.
Which of the following is an example of how the Principle of Beneficence can be applied to a ...
Medical Informatics IRB Exam Questions
Correctly Answered.
Which of the following are the three principles discussed in the Belmont Report? - CORRECT ANSWER
Respect for Persons, Beneficence, Justice.
Which of the following is an example of how the Principle of Beneficence can be applied to a study
employing human subjects? - CORRECT ANSWER Determining that the study has a maximization of
benefits and a minimization of risks.
All of the following are true regarding the Belmont Report, EXCEPT: - CORRECT ANSWER The Belmont
Report indicates that it is necessary to rigorously avoid conflicts of interest.
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? - CORRECT ANSWER 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? - CORRECT ANSWER 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? - CORRECT ANSWER 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: - CORRECT
ANSWER The changes must be immediately implemented for the health and well being of the subject.
IRB continuing review of an approved protocol must: - CORRECT ANSWER Occur at least annually.
Which of the following brought increased public attention to the problems with the IRB system? -
CORRECT ANSWER Death of Jesse Gelsinger
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