CITI Training Questions and Answers

Belmont Report and its principles - AnswerWhich of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - Answer-Determining that the study has a maximization of the benefits and a minimization of risks Which of the following are the three principles discussed in the Belmont Report? - Answer-respect for persons, beneficence, justice The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: - Answer-persons with diminished autonomy are entitled to protection History and ethics of human subjects research - AnswerWhich of the following brought increased public attention to the problems with the IRB system? - Answer-Death of Research Subject (Jesse Gelsinger) Informed consent is considered an application of which Belmont principle? - Answer-respect for persons The National Research Act of 1974 - Answer-Established the National Commission Which of the following was the result of the Beecher article? - Answer-Realization that ethical abuses are not limited to the Nazi regime Which of the following is included in the Nuremberg Code: - Answer-voluntary consent Research involving prisoners - AnswerA 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