MIMIC数据库使用权限获取CITI考试题

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 applie

2、d 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 seco

3、nd, 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 th

4、e 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

5、Code: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:Wh

6、ich 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.

8、Q2: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 use

9、d 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

10、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-Based Research (ID 5) Q&AQ1:In order to grant a waiver or alteration of the requirements of inform

11、ed 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 su

12、rveillance 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 d

13、efinition 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 c

14、onsent 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 const

15、itutes: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 biologica

16、l 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

17、 human subjects research according to the definition of human subjects research in the federal regulations?A:No, because Investigator B cannot readily ascertain the identity of the source individual and Investigator B has agreed not to attempt re-identification.Q3:Which of the following statements i

18、s accurate in determining subject risk involved in a genetic study:A:Understanding the purpose and context of a specific study is critical in determining the risk involvedQ4:Which choice is the best definition of “genetic determinism?”A:Genes are primarily responsible for human traits, including hea

19、lth, behavior, and diseaseQ5:When conducting research that involves collecting biological specimens for genetic testing, which of the following issues is the most important for the IRB to consider?A:Effects of findings on other family membersQ6:Investigator A conducts research on emphysema using bio

20、specimens from human subjects. The consent form indicates that the research will focus exclusively on emphysema. Investigator B wishes to use the biospecimens for research on lung cancer. Can Investigator B use the specimens for cancer research without re-consent if the specimens are de-identified?A

21、:Yes, if the biospecimens are de-identified then the research is no longer considered human subjects research.Q7:Which choice best describes the purpose of most pharmacogenomic research?A:To evaluate the association between individual genotypes and the safety and efficacy of a particular drug or cla

22、ss of drugsQ8: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:A:De-IdentifiedQ9:Investigator A conducts research

23、on emphysema using biospecimens from human subjects. The consent form indicates that the research will focus exclusively on emphysema. Investigator B wishes to use the biospecimens for research on lung cancer. Can Investigator B use the specimens for cancer research without re-consent if the specime

24、ns are de-identified?A:Yes, if the biospecimens are de-identified then the research is no longer considered human subjects research-Mimic Class 6 Populations in Research Requiring Additional Considerations and/or Protections (ID 16680) Q&AQ1:Identify the following groups that are protected in the fe

25、deral regulations (45 CFR 46), specifically in Subparts B, C, and D with additional protections:A:Pregnant women, prisoners, childrenQ2:A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of:A:Economic

26、vulnerabilityQ3:According to the authors, there are four common abuses that historically are described as giving rise to vulnerability. Which response below contains the correct four?A:Physical control, coercion, undue influence, and manipulationQ4:Which is an example of a situation where deferentia

27、l vulnerability might be a factor?A:A physician recruiting patients to be subjectsQ5:Which is true of inducements in research?A:Inducements constitute an “undue influence” if they alter a potential subjects decision-making processes, such that they do not appropriately weigh the risk-benefit relatio

28、nship of the research.Q6:When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:A:Is there a power differential between researchers and subjects?Q7:Subjects with a serious illness may be at risk for exploitation becaus

29、e they may be desperate for a possible cure. This is an example of:A:Medical vulnerabilityQ8:When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:A:Is there a power differential between researchers and subjects?-Mimi

30、c Class 7 Research and HIPAA Privacy Protections (ID 14) Q&AQ1:The HIPAA minimum necessary standard appliesA:To all human subjects research that uses PHI without an authorization from the data subjectQ2:A HIPAA authorization has which of the following characteristicsA:Uses plain language that the da

31、ta subject can understand, similar to the requirement for an informed consent documentQ3:Under HIPAA, a “disclosure accounting” is requiredA:For all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets.Q4:Under HIPAA, retrospective resear

32、ch (a.k.a., data mining) on collections of PHI generallyA:Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorizationQ5:Recruiting into researchA:Can qualify as an activity “preparatory to research,” at least for the initial contact, but data sho

33、uld not leave the covered entityQ6:A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPTA:Data that does not cross state lines when disclosed by the covered entity.Q7:When required, the infor

34、mation provided to the data subject in a HIPAA disclosure accountingA:must be more detailed for disclosures that involve fewer than 50 subject recordsQ8:HIPAA protects a category of information known as protected health information (PHI). PHI covered under HIPAA includes:A:Identifiable health inform

35、ation that is created or held by covered entities and their business associates.Q9:HIPAA includes in its definition of “research,” activities related to:A:Development of generalizable knowledge.Q10:If youre unsure about the particulars of HIPAA research requirements at your organization or have ques

36、tions, you can usually consult with:A:An organizational IRB or Privacy Board, privacy official (Privacy Officer), or security official (Security Officer), depending on the issueQ11:HIPAAs protections for health information used for research purposesA:Supplement those of the Common Rule and FDA.-Mimi

37、c Class 8 Conflicts of Interest in Human Subjects Research (ID 17464) Q&AQ1:A researchers membership on an advisory board with an organization sponsoring research can create a COI because:A:It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the resear

38、chs successQ2:What is the term for management controls that are built in to a research study (for example, independent data analysis)?A:Inherent controlsQ3:The FDA regulations governing disclosure of individual COIs require:A:Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studiesQ4:The peer review process can