CITI Training. Exam Questions with accurate answers. 100% proven pass rate.

CITI Training. Exam Questions with accurate answers. 100% proven pass rate. 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. 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?