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1、MIMIC数据库使用权限获取，CITI考试题-Mimic Class 1 Belmont Report and Its Principles (ID 1127) Q&AQ1:Which of the following are the three principles discussed in the Belmont Report?A:Respect for Persons, Beneficence, JusticeQ2:Which of the following is an example of how the principle of beneficence can be applied
2、 to a study employing human subjects?A:Determining that the study has a maximization of benefits and a minimization of risksQ3:The Belmont Reports principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and secon
3、d, thatA:Persons with diminished autonomy are entitled to protection-Mimic Class 2 History and Ethics of Human Subjects Research (ID 498) Q&AQ1:The National Research Act of 1974A:Established the National Commission.Q2:Which of the following brought increased public attention to the problems with the
4、 IRB system?A:Death of Research Subject (Jesse Gelsinger)Q3:Informed consent is considered an application of which Belmont principle?A:Respect for PersonsQ4:Issued in 1974, 45 CFR 46 raised to regulatory status:A:US Public Health Service PolicyQ5:Which of the following is included in the Nuremberg C
5、ode:A:Voluntary consentQ6:The use of prisoners in research is a concern under the Belmont principle of Justice because:A:Prisoners may not be used to conduct research that only benefits the larger societyQ7:Issued in 1974, 45 CFR 46 raised to regulatory status:A:US Public Health Service PolicyQ8:Whi
6、ch of the following was the result of the Beecher article?A:Realization that ethical abuses are not limited to the Nazi regime-Mimic Class 3 Basic Institutional Review Board (IRB) Regulations and Review Process (ID 2) Q&AQ1:A subject in a clinical research trial experiences a serious, unanticipated
7、adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?A:Report the adverse drug experience in a timely manner, in keeping with the IRBs policies and procedures, using the forms or the mechanism provided by the IRB.Q
8、2:How long is an investigator required to keep consent documents, IRB correspondence, and research records?A:For a minimum of three years after completion of the studyQ3:According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used
9、 by the IRB?A:The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulationsQ4:Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if:A:The changes must be immediately implemented for the h
10、ealth and well-being of the subject.Q5:IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must:A:Occur at least annually.-Mimic Class 4 Records-Based Research (ID 5) Q&AQ1:In order to grant a waiver or alteration of the requirements of informe
11、d consent, an IRB must find which of the following:A:The research could not practicably be carried out without the waiver of consent.Q2:A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for sur
12、veillance purposes from 1996-2006. The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal de
13、finition of human subjects.Which of the following considerations was relevant to the IRBs determination that this activity does not constitute research with human subjects?A:The researcher will not be interacting/intervening with subjects and the data has no identifiers.Q3:An investigator obtains co
14、nsent and HIPAA authorization from subjects to review their medical records and HIV status. He plans to go back to the medical record, so the HIV status information is stored along with subject identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident consti
15、tutes:A:A breach of confidentiality-Mimic Class 5 Genetic Research in Human Populations (ID 6) Q&AQ1:Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA) protects individuals from:A:Health insurance and employment discriminationQ2:Investigator A has biological
16、 specimens that are coded and linked to identifiers of the source individuals. Investigator A provides the specimens to Investigator B but does not provide the individual identifiers. Investigator B agrees not to re-identify the source individuals. Is Investigator Bs research using the biospecimens human subjects research according to the definition
