RM: Citi Modules 2023/2024 Graded A+

Which of the following was the result of the Beecher article? - ANSWER-Realization that ethical abuses are not limited to the Nazi regime 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 Issued in 1974, 45 CFR 46 raised to regulatory status: - ANSWER-US Public Health Service Policy (45 CFR 46 raised to regulatory status the US Public Health Service policy of 1966 "Clinical research and investigation involving human beings".) Which of the following brought increased public attention to the problems with the IRB system? - ANSWER-Death of Jesse Gelsinger (Although all of these are related to the problems with the IRB system, the death of Jesse Gelsinger was what received public attention.) Which of the following is included in the Nuremberg Code? - ANSWER-Voluntary Consent Informed consent is considered an application of which Belmont principle? **** - ANSWER-Respect for Persons (Respect for persons involves respecting individual autonomy in the decision to participate in research. That respect is implemented through the process of informed consent) 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 & research records? - ANSWER-For a *minimum of three years* after completion of the study. (May be required to keep them longer than 3 years) 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 & 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 & well being of the subject.