RM: CITI Module Quizzes and Answers Already Passed

RM: CITI Module Quizzes and Answers Already Passed Which of the following are the three principles discussed in the Belmont Report? 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? 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: The Belmont Report indicates that it is necessary to rigorously avoid conflicts of interest. Which of the following brought increased public attention to the problems with the IRB system? Death of Jesse Gelsinger Issued in 1974, 45 CFR 46 raised to regulatory status: US Public Health Service Policy The use of prisoners in research is a concern under the Belmont principle of Justice because: Prisoners may be used to conduct research that only benefits the larger society Informed consent is considered an application of which Belmont principle? Respect for Persons Which of the following was the result of the Beecher article? Realization that ethical abuses are not limited to the Nazi regime The National Research Act of 1974 Established the National Commission. Which of the following is included in the Nuremberg Code: Voluntary consent 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. 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 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 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. IRB continuing review of an approved protocol must: Occur at least annually. The purpose of informed consent is: 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. 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.