Ethical Issues in Clinical Research, Exams of Nursing

Download Ethical Issues in Clinical Research and more Exams Nursing in PDF only on Docsity! Citi exams QUESTIONS WITH RIGHT ANSWER VERIFIED BY AN EXPERT. 1. Which of the following is included in the Nuremberg Code: - Correct answer voluntary consent 2. The National Research Act of 1974 - Correct answer Established the National Commission. 3. Informed consent is considered an application of which Belmont principle? - Correct answer Respect for Persons 4. Issued in 1974, 45 CFR 46 raised to regulatory status: - Correct answer US Public Health Service Policy 5. Which of the following brought increased public attention to the problems with the IRB system? - Correct answer Death of Jesse Gelsinger 6. The use of prisoners in research is a concern under the Belmont principle of Justice because: - Correct answer Prisoners may be used to conduct research that only benefits the larger society 7. Which of the following was the result of the Beecher article? - Correct answer Realization that ethical abuses are not limited to the Nazi regime 8. 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. 9. 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 10.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 11.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. 12. IRB continuing review of an approved protocol must: - Correct answer Occur at least annually. 13.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: - Correct 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. 14.The purpose of informed consent is: - Correct 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. 15.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? - Correct 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. 16.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. 17.Which of the following is the most appropriate action to take for the investigator? - Correct answer 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. 18.A general requirement for the informed consent is that no informed consent may include 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? - Correct answer I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.