RM: CITI Module Quizzes and Answers Already Passed

RM: CITI Module Quizzes and Answers Already Passed Which of the following are the three principles discussed in the Belmont Report? ✔✔Respect for Persons, Beneficence, Justice. Which of the following is an example of ...

RM: CITI Module Quizzes and Answers Already Passed Which of the following are the three principles discussed in the Belmont Report? ✔✔Respect for Persons, Beneficence, Justice. Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? ✔✔Determining that the study has a maximization of benefits and a minimization of risks. All of the following are true regarding the Belmont Report, EXCEPT: ✔✔The Belmont Report indicates that it is necessary to rigorously avoid conflicts of interest. Which of the following brought increased public attention to the problems with the IRB system? ✔✔Death of Jesse Gelsinger Issued in 1974, 45 CFR 46 raised to regulatory status: ✔✔US Public Health Service Policy The use of prisoners in research is a concern under the Belmont principle of Justice because: ✔✔Prisoners may be used to conduct research that only benefits the larger society Informed consent is considered an application of which Belmont principle? ✔✔Respect for Persons Which of the following was the result of the Beecher article? ✔✔Realization that ethical abuses are not limited to the Nazi regime The National Research Act of 1974 ✔✔Established the National Commission. Which of the following is included in the Nuremberg Code: ✔✔Voluntary consent A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? ✔✔Report the adverse 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. How long is an investigator required to keep consent documents, IRB correspondence, and research records? ✔✔For a minimum of three years after completion of the study According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB? ✔✔The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if: ✔✔The changes must be immediately implemented for the health and well being of the subject. IRB continuing review of an approved protocol must: ✔✔Occur at least annually. The purpose of informed consent is: ✔✔To provide a potential subject with appropriate information in an appropriate manner and allow that person to make an informed decision about participation in research. An elderly gentleman, whose wife is his legally authorized representative since his strokes several years ago, was recently diagnosed with lung cancer. He is eligible for a clinical trial using a new investigational drug that aims to treat lung cancer. He is able to express interest, shows a basic understanding of the nature of the trial, and gives his assent to participation. The subject's wife is out of town on a business trip. Which of the following is the most appropriate action to take for the investigator? ✔✔Send a copy of the informed consent via facsimile to the subject's wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back. A general requirement for the informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language? ✔✔I waive any possibility of compensation for injuries that I may receive as a result of participation in this research. 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 from the individual's legal representative and no alternative method or recognized therapy is available. Under the FDA regulations for using test articles, which of the following describes the best course of action for the investigator: ✔✔The investigator and an independent physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later. A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the study is on going, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following? ✔✔Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug. A researcher is conducting a written survey about people's attitudes toward walking as an exercise option at the local shopping mall that supports a walking program. The survey is anonymous (without codes, names or other information) and volunteers may complete the survey and place it in a box at the shopping mall exits. Which of the following is the most important issue that the researcher addressed in planning the research? ✔✔Confidentiality of the individual subject's responses A researcher wants to invite therapists to participate in small focus groups to discuss their perceptions regarding "troubled" adolescent girls and the relationships they have with their parents. Specific clients of the therapists will not be discussed. Which of the following will be the most important issue for the researcher to consider when planning the research? ✔✔Breach of confidentiality from the focus group participants Which of the following most accurately describes the risks associated with SBR? ✔✔Less predictable, more variable and less treatable than physical harms Which of the following is not considered an SBR data collections method? ✔✔hearing/audiological screenings An investigator obtains consent 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 patient identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes: ✔✔A breach of confidentiality. 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 surveillance 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 definition of human subjects. Which of the following considerations was relevant to the IRB's determination that this activity does not constitute research with human subjects? ✔✔The researcher will not be interacting/intervening with subjects and the data has no identifiers. As part of a research study, a physician plans to review medical records of the next 50 of her patients who require magnetic resonance imaging (MRI) scans for clinical treatment to explore factors related to patients requiring MRI scans. The physician will review the medical records, and write down the clinical indication for the scans, any existing injuries, current prescriptions, as well as other clinical data. The clinical indication for the scans and the other clinical data will be collected in the medical records for treatment purposes as part of standard clinical care. The physician will use a coding system to be able to identify the patient's information; however, the "key" to the coding system will be stored separately from the data in a locked cabinet that only she will have access to. Which of the following is true? ✔✔The study is human subject research which is eligible for expedited review. Which of the following statements is accurate in determining subject risk involved in a genetic study: ✔✔Understanding the purpose and context of a specific study is critical in determining the risk involved When an IRB is reviewing a research stud