CITI Training questions correctly answered 2023 verified

CITI Training questions correctly answered 2023 verifiedA 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. Institutional vulnerability B. Communicative vulnerability C. Economic vulnerability D. Social vulnerability C. Economic vulnerability 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. Coercion, undue influence, neglect and disrespect B. Physical control, coercion, undue influence, and manipulation C. Prejudice, physical control, manipulation and coercion D. Physical control, coercion, undue influence and neglect B. Physical control, coercion, undue influence, and manipulation Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C, and D with additional protections: A. Pregnant women, prisoners, children B. Prisoners, children, and older adults C. Pregnant women, prisoners, and individuals who are economically disadvantaged D. Children, prisoners, and individuals who are critically ill A. Pregnant women, prisoners, children Subjects with a serious illness may be at risk for exploitation since they may be desperate for a possible cure. This is an example of A. Deferential vulnerability B. Therapeutic misconception C. Medical Vulnerability D. Economic vulnerability C. Medical Vulnerability Which is an example of a situation where deferential vulnerability might be a factor? A. A college professor recruiting among his students B. An army medical officer recruiting subjects among lower ranks C. A physician recruiting his patients D. An employer recruiting among persons who directly report to him C. A physician recruiting his patients In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for: A. Economic vulnerability B. Communicative vulnerability C. Situational cognitive vulnerability D. Capacity-related cognitive vulnerability C. Situational cognitive vulnerability When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider: A. Are there adequate resources to conduct the study? B. Is there a power differential between researchers and subjects? C. Are the research procedures greater than minimal risk of harm? D. Has the researcher completed required training? B. Is there a power differential between researchers and subjects? Which is true of inducements in research? A. Like coercion, undue inducement is easy for IRBs to determine. B. Offering $10 for an hour long research study constitutes undue inducement. C. Inducements, like coercion, are always inappropriate, as they violate the ethical principle of respect for persons. D. Inducements constitute an "undue influence" if they alter a potential subject's decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research. D. Inducements constitute an "undue influence" if they alter a potential subject's decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research. NBAC proposed a concept of vulnerability in research based on features of potential subjects or of their situation. Which of the following was NOT included as possibly leading to vulnerability? A. High risk for exploitation B. High potential for individual benefit from participating in research C. Difficulty providing voluntary, informed consent arising from limitations in decision-making capacity D. Difficulty providing voluntary, informed consent arising from or situational circumstances B. High potential for individual benefit from participating in research Which of the following brought increased public attention to the problems with the IRB system? A. HHS Inspector General Report of 1998 B. 1983 Presidential Commission Report C. "Shut Downs" by OHRP D. Death of Jesse Gelsinger D. Death of Jesse Gelsinger Issued in 1974, 45 CFR 46 raised which of the following to regulatory status? A. The 1974 National Research Act B. The Nuremberg Code C. Kefauver-Harris Drug Amendments to the Federal Food, Drug & Cosmetics Act D. US Public Health Service Policy D. US Public Health Service Policy The National Research Act of 1974 A. Identified the basic ethical principles of human subjects research B. Identified guidelines to ensure the ethical conduct of research. C. Required that all federal agencies have the same regulations governing human subjects research. D. Established the National Commission. D. Established the National Commission. Informed consent is considered an application of which Belmont principle? A. Non-maleficence B. Beneficence C. Respect for Persons D. Justice C. Respect for Persons Which of the following concerns is related to the Belmont Principle of Justice: A. Prisoners are not free to say no B. Privacy and confidentiality concerns when research occurs in prisons C. Prisoners participating in research that only benefits the larger society D. Prisoners are not a representative sample of the general population C. Prisoners participating in research that only benefits the larger society Which of the following was the result of the Beecher article? A. An identification of basic ethical principles B. Additional FDA regulations C. Realization that ethical abuses are not limited to the Nazi regime D. Multiple Congressional hearings C. Realization that ethical abuses are not limited to the Nazi regime Which of the following is included in the Nuremberg Code: A. Voluntary consent B. Equitable selection of subjects C. Additional Protection for vulnerable subjects D. Confidentiality of data A. Voluntary consent A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates' friends, family members and business acquaintances. The researcher submits the research proposal to the institution's IRB. What action can he expect by the IRB? A. The IRB will not review this study because it does not involve an investigational new device. B. The IRB will not review this study because it does not include human subjects as defined by the federal regulations. C. The IRB will not review this study because it is not research as defined by the federal regulations. D. The IRB will review this study because it includes human subjects and is considered research. C. The IRB will not review this study because it is not research as defined by the federal regulations. According to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or: A. Identifiable private information. B. De-identified private information. C. Observations of public behavior. D. Identifiable public information. A. Identifiable private information. According to the federal regulations, which of the following studies meets the definition of research with human subjects? A. An organization for women academics in engineering asks a federal agency to provide the number of women investigators funded by that agency to include in a report for its membership. B. A university designs an in-house study to improve the mentoring of women students in its engineering department with the proposed outcome consisting of a report of recommendations for the department. C. An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests. D. A researcher receives anonymized data for secondary analysis from a survey about gender-related differences in stress levels conducted by a colleague at another university. C. An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests. According to the federal regulations, which of the following studies meets the definition of research with human subjects? A. A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors. B. Undergraduate students in a field methods class are assigned a research question and asked to interview another classmate, to be followed by a class discussion on interview techniques. C. A researcher conducts a comparison of the comments made in a publicly available blog and the blogger's comments on a similar topic in a weekly magazine. D. A researcher sets up a meeting with the superintendent of a large and diverse public school system to get data about the ethnic composition of the school system and the number of students receiving free lunches. A. A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors. According to the federal regulations, which of the following studies meets the definition of research with human subjects? A. A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression. B. A researcher asks the director of a local free clinic about the number of patients in the last two years with newly diagnosed HIV/AIDS. C. A researcher uses the Customs Office's passenger lists for ships bringing immigrants to the US between to track the numbers of immigrants from certain ethnic groups. D. A researcher conducts a linguistic study of comments posted on a local public blog. A. A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression. A medical record is an example of: A. Public behavior. B. Public information. C. Private information. D. Private behavior. C. Private information. According to the federal regulations, which of the following studies meets the definition of research with human subjects? A. The collection of data, by a playground designer hired by the superintendent of schools, about the physical dimensions of school playgrounds, presence of fencing, and the kinds of equipment currently provided. B. An analysis of aggregate data comparing statewide high school graduation rates provided by the State Department of Public Instruction, using county tax information. C. A feasibility study for implementing a year-round school program, focusing on economic issues such a facilities utilization and transportation costs. D. A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period. D. A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period. Census data (the final report as published by the Census Bureau) is an example of: A. Private behavior. B. Public behavior. C. Private information. D. Public information. D. Public information. 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? A. Do not report the adverse drug experience to the IRB since it is a common adverse experience. B. Report the adverse drug experience to the IRB only if there are several other occurrences. C. 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. D. Report the adverse drug experience as part of the continuing review report. C. 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? A. Until data analysis is complete B. For a minimum of three years after completion of the study C. As long as the investigator is at that institution D. Until the study is closed B. For a minimum of three years after completion of the study Multiple Choice/Single Answer - Select only one answer According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB? A. The study includes only research subjects that are healthy volunteers. B. The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations C. The study does not require informed consent or survey instruments. D. The study is required for a student research project B. 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: A. The investigator keeps careful records of all changes and includes them in the final report. B. They are eligible for review using expedited procedures. C. They only involve changes to the consent form. D. The changes must be immediately implemented for the health and well being of the subject. D. The changes must be immediately implemented for the health and well being of the subject. IRB continuing review of an approved protocol must: A. Be conducted by a convened IRB. B. Occur only when the level of risk changes. C. Include copies of all signed consent forms. D. Occur at least annually. D. Occur at least annually. 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? A. Exclude the man from the study. B. 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. C. The investigator can go ahead and enroll the man without a signed consent. D. Request the IRB meet and waive the requirement for a signed informed consent. B. 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? A. I waive any possibility of compensation for injuries that I may receive as a result of participation in this research. B. The investigator may stop you from participating in this research without your consent if you experience side effects that make your condition worse. If you become ill during the research, you may have to drop out. C. 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. D. In the event of any injury you may have related to this research, you will be given medical treatment. A. I waive any possibility of compensation for injuries that I may receive as a result of participation in this research. 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? A. Withhold this new information to avoid confusing the subject with other treatment options or alternatives B. 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. C. Do not tell the subject about the new drug since physicians have the right to try out new treatments with their patients D. Tell the subject about the new drug but discourage him from switching treatments until the study is completed B. 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. The purpose of informed consent is: A. To obtain a signature from a study subject in order to protect the investigator, the study staff and the institution. B. To obtain a signature from a study subject in order to document his or her agreement to participate in research. C. 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. D. To document the investigator's participation in the consent process. C. 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 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: A. Do not use the test article until either the subject or the subject's legal representative can give consent. B. Use the test article without obtaining consent from the subject or the legal representative then notify the IRB. C. 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. D. Submit a research protocol to the IRB and justify an expedited review approval of the consent document so test article can be used immediately. C. 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.