CITI Training Quiz Questions

CITI Training Quiz Questions 1. Which of the following are the three principles discussed in the Belmont Report? Ans- 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 autonomous agents, and second, that: Ans- 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 employing human subjects? Ans- Determining that the study has a maximization of benefits and a minimization of risks. 4. The Data Manager should review the study protocol: Ans- to understand primary and secondary endpoints 5. When designing a database and data collection instruments for a study, the Data Manager should: Ans- 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 define quality the same way in order to produce a high quality database. Ans- False Which member of a study team is ultimately responsible for the conduct of the study at a site? Ans- 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? Ans- The Clinical Research Associate In order for a quality process to work, study team members must understand all of the following EXCEPT: Ans- how to perform the other team members' jobs Typical study conduct activities performed by the data manager include all of the following EXCEPT: Ansdefining edit checks At what point should a Data Manager get involved with the database development? Ans- At study startup Prior to locking a database, a data manager should ensure all data have been entered and all queries are resolved. Ans- True Which of the following is included in the Nuremberg Code: A. Voluntary consent B. Confidentiality of data C. Equitable selection of subjects D. Additional protection for vulnerable subjects Ans- 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 Ans- 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 representative 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 understanding research Ans- 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 Persons Ans- 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 Ans- 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: Ans- Understanding the purpose and context of a specific study is critical in determining the risk involved As of January 2015, the NIH expects investigators to obtain the informed (valid) consent of research participants in NIH -funded genetic research for broad research use of data and data sharing, even if the cell lines or specimens are: Ans- De-Identified Under which of the following conditions is it appropriate to re-contact the individuals who provided biological specimens? Ans- Original signed consent documents include provisions for recontacting subjects Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA) protects individuals from: Ans- Health insurance and employment discrimination Which choice is the best definition of "genetic determinism?" Ans- Genes are primarily responsible for human traits, including health, behavior, and disease Under which circumstance does the FDA allow verbal consent prior to participation in a research study? A. The subject has a legally authorized representative (LAR). B. The study is minimal risk. C. The subject is illiterate. D. The study is greater than minimal risk. Ans- The study is minimal risk. 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 for the individual's legal representative. Under the FDA regulations, which of the following describes the best course of action for the investigator: A. Do not use the test article until either the subject or the subject's legally authorized representative can give consent. B. Submit a research protocol to the IRB and justify an expedited review approval of the consent document so the test article can be used immediately. C. The investigator and another physician not part of the study team agree that the situation necessitates the use of the test article and the IRB will be notified later. D. Sign the consent form on behalf of the subject and use the test article. Ans- The investigator and another physician not part of the study team agree that the situation necessitates the use of the test article and the IRB will be notified later. Which of the following statements in a consent form is an example of exculpatory language? A. In the event of any injury related to this research, you will be given medical treatment. B. Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with your doctor or your right to health care or other services that you may be eligible for. C. The investigator may stop you from participating in thi