1. Which of the following are the three principles discussed in the Belmont Report? -
Correct answer-Respect for Persons, Beneficence, Justice
2. The Belmont Report's principle of respect for persons incorporates at least two ethical
convictions: first, that individuals should be treated as auto...
CITI Training Quiz Questions and Answers 2022 1. Which of the following are the three principles discussed in the Belmont Report? - Correct answer -Respect for Persons, Beneficence, Justice 2. The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, t hat individuals should be treated as autonomous agents, and second, that: - Correct answer -Persons with diminished autonomy are entitled to protection. 3. Which of the following is an example of how the principle of beneficence can be applied to a study e mploying human subjects? - Correct answer -Determining that the study has a maximization of benefits and a minimization of risks. 4. The Data Manager should review the study protocol: - Correct answer -to understand primary and secondary endpoints 5. When designing a database and data collection instruments for a study, the Data Manager should: - Correct answer -Use standards to reduce the time required to set up the database and to increase the consistency of the data Every member of a study team must defi ne quality the same way in order to produce a high quality database. - Correct answer -False Which member of a study team is ultimately responsible for the conduct of the study at a site? - Correct answer -The Investigator Which member of a study team acts as the liaison between a sponsor and site, ensuring that reported data are verifiable to source documentation? - Correct answer -The Clinical Research Associate In order for a quality process to work, study team members must understand all of the followin g EXCEPT: - Correct answer -how to perform the other team members' jobs Typical study conduct activities performed by the data manager include all of the following EXCEPT: - Correct answer -defining edit checks At what point should a Data Manager get invol ved with the database development? - Correct answer -At study startup Prior to locking a database, a data manager should ensure all data have been entered and all queries are resolved. - Correct answer -True Which of the following is included in the Nuremb erg Code: A. Voluntary consent B. Confidentiality of data C. Equitable selection of subjects D. Additional protection for vulnerable subjects - Correct answer -Voluntary consent Which of the following brought increased public attention to the problems with the IRB system? A. Death of Research Subject (Jesse Gelsinger) B. "Shut Downs" by OHRP C. HHS Inspector General Report of 1998 D. 1983 Presidential Commission Report - Correct answer -Death of Research Subject (Jesse Gelsinger) The use of prisoners in research is a concern under the Belmont principle of Justice because: A. Prisoners are not a r epresentative sample of the general population B. Prisoners are not free to say no C. Prisoners may not be used to conduct research that only benefits the larger society D. Prisoners are less educated that the general population and have difficulty underst anding research - Correct answer -Prisoners may not be used to conduct research that only benefits the larger society Informed consent is considered an application of which Belmont principle? A. Beneficence B. Justice C. Non -maleficence D. Respect for Per sons - Correct answer -Respect for persons Which of the following was the result of the Beecher article? A. Additional FDA regulations B. Realization that ethical abuses are not limited to the Nazi regime C. An identification of basic ethical principles D. Multiple Congressional hearings - Correct answer -Realization that ethical abuses are not limited to the Nazi regime Which of the following statements is accurate in determining subject risk involved in a genetic study: - Correct answer -Understanding the purpose and context of a specific study is critical in determining the risk involved
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