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&A
Q1:Which of the following are the three principles discusd in the Belmont Report?
A:Respect for Persons, Beneficence, Justice
Q2:Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects?
A:Determining that the study has a maximization of benefits and a minimization of risks
Q3: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 cond, that
A:Persons with diminished autonomy are entitled to protection
--Mimic Class 2 History and Ethics of Human Subjects Rearch (ID 498) Q&A
Q1:The National Rearch Act of 1974
A:Established the National Commission.
Q2:Which of the following brought incread public attention to the problems with the IRB system?
A:Death of Rearch Subject (Jes Gelsinger)
Q3:Informed connt is considered an application of which Belmont principle?
A:Respect for Persons
Q4:Issued in 1974, 45 CFR 46 raid to regulatory status:
A:US Public Health Service Policy
Q5:Which of the following is included in the Nuremberg Code:
A:Voluntary connt
Q6:The u of prisoners in rearch is a concern under the Belmont principle of Justice becau:
A:Prisoners may not be ud to conduct rearch that only benefits the larger society
Q7:Issued in 1974, 45 CFR 46 raid to regulatory status:
A:US Public Health Service Policy
Q8:Which of the following was the result of the Beecher article?
A:Realization that ethical abus are not limited to the Nazi regime
--Mimic Class 3 Basic Institutional Review Board (IRB) Regulations and Review Process (ID 2) Q&A
Q1:A subject in a clinical rearch trial experiences a rious, unanticipated adver drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adver event occurrence?
A:Report the adver 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.
Q2:How long is an investigator required to keep connt documents, IRB correspondence, and rearch records?
A:For a minimum of three years after completion of the study
Q3:According to federal regulations, which of the following best describes when expedited review of a new, propod study may be ud 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 regulations
Q4:Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if:
A:The changes must be immediately implemented for the health 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-Bad Rearch (ID 5) Q&A
Q1:In order to grant a waiver or alteration of the requirements of informed connt, an IRB must find which of the following:
A:The rearch could not practicably be carried out without the waiver of connt.
Q2:A rearcher wants to conduct a condary analysis using a Centers for Dia Control and Prevention (CDC) databa that was collected by the agency solely for surveillance purpos from 1996-2006. The rearcher did not participate in the initial collection of the data. The databa is publicly available. The databa does not include any identifiers. The IRB makes a determination that the individuals who records will be reviewed do not meet the federal definition of human subjects.
Which of the following considerations was relevant to the IRB's determination that this activity does not constitute rearch with human subjects?
A:The rearcher will not be interacting/intervening with subjects and the data has no identifiers.
Q3:An investigator obtains connt 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 databa that he keeps on his laptop computer. His laptop is stolen. This incident constitutes:
A:A breach of confidentiality
--Mimic Class 5 Genetic Rearch in Human Populations (ID 6) Q&A
Q1:Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA) protects individuals from:
A:Health insurance and employment discrimination
