CITI Exam Study Materials [[KEEP_s+]] - Test-Ready Solutions Pack

CITI Exam Study Materials [[KEEP_s+]] - Test-Ready Solutions Pack Which of the following is included in the Nuremberg Code: - answer - voluntary consent The National Research Act of 1974 - answer - Established the National Commission. Informed consent is considered an application of which Belmont principle? - answer - Respect for Persons Issued in 1974, 45 CFR 46 raised to regulatory status: - answer - US Public Health Service Policy Which of the following brought increased public attention to the problems with the IRB system? - answer - Death of Jesse Gelsinger The use of prisoners in research is a concern under the Belmont principle of Justice because: - answer - Prisoners may be used to conduct research that only benefits the larger society Which of the following was the result of the Beecher article? - answer - 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? - 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? - 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? - 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: - answer - The changes must be immediately implemented for the health and well being of the subject. IRB continuing review of an approved protocol must: - answer - 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: - answer - The investigator and an independent physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later. The purpose of informed consent is: - answer - To provide a potential subject with appropriate information in an appropriate manner and allow that person to make an informed decision about participation in research. A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the study is on going, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following? - answer - Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug. An elderly gentleman, whose wife is his legally authorized representative 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