CITI Training(questions and answers)
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 - Answer 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 - Answer 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 - Answer 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 - Answer 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 - Answer 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
,CITI Training(questions and answers)
B. Communicative vulnerability
C. Situational cognitive vulnerability
D. Capacity-related cognitive vulnerability - Answer 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? - Answer 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. - Answer 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 - Answer 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 - Answer D. Death of Jesse Gelsinger
Issued in 1974, 45 CFR 46 raised which of the following to regulatory status?
, CITI Training(questions and answers)
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 - Answer 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. - Answer 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 - Answer 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 - Answer 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 - Answer 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 - Answer A. Voluntary consent
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 - Answer 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 - Answer 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 - Answer 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 - Answer 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 - Answer 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
,CITI Training(questions and answers)
B. Communicative vulnerability
C. Situational cognitive vulnerability
D. Capacity-related cognitive vulnerability - Answer 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? - Answer 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. - Answer 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 - Answer 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 - Answer D. Death of Jesse Gelsinger
Issued in 1974, 45 CFR 46 raised which of the following to regulatory status?
, CITI Training(questions and answers)
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 - Answer 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. - Answer 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 - Answer 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 - Answer 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 - Answer 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 - Answer A. Voluntary consent
