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CITI TRAINING, MODULES 1-24
(BIOMEDICAL RESEARCH) QUESTIONS
WITH DETAILED VERIFIED ANSWERS
The Belmont Report's principle of respect for persons incorporates at
least two ethical convictions: first, that individuals should be treated as
autonomous agents, and second, that:
A. Persons with diminished autonomy should only participate in no more
than minimal risk research.
B. Persons with diminished autonomy should be excluded from research.
C. Persons with diminished autonomy are entitled to protection.
D. Persons involved in research cannot financially benefit. Ans: C.
Persons with diminished autonomy are entitled to protection.
Which of the following is an example of how the principle of beneficence
can be applied to a study employing human subjects?
A. Ensuring that persons with diminished autonomy are protected.
B. Providing detailed information about the study and obtaining the
subject's consent to participate.
C. Determining that the study has a maximization of benefits and a
minimization of risks.
D. Ensuring that the selection of subjects includes people from all
segments of the population. Ans: C. Determining that the study has a
maximization of benefits and a minimization of risks.
Which of the following are the three principles discussed in the Belmont
Report?
A. IRB Review, Federal Regulations, Declaration of Helsinki
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B. Privacy, Confidentiality, Equitable Selection of Subjects
C. Informed Consent, Institutional Assurance, Researcher Responsibility
D. Respect for Persons, Beneficence, Justice Ans: D. Respect for
Persons, Beneficence, Justice
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. Has the researcher completed required training?
D. Are the research procedures greater than minimal risk of harm? Ans:
B. Is there a power differential between researchers and subjects?
Which is an example of a situation where deferential vulnerability might
be a factor?
A. An army medical officer recruiting subjects among lower ranks
B. A college professor recruiting among their students
C. A physician recruiting patients to be subjects
D. An employer recruiting among persons who directly report to them
Ans: C. A physician recruiting patients to be subjects
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. Situational cognitive vulnerability
C. Capacity-related cognitive vulnerability
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D. Communicative vulnerability Ans: B. Situational cognitive
vulnerability
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, and mentally disabled
B. Children, prisoners, and terminally ill
C. Prisoners, children, and elderly
D. Pregnant women, prisoners, children Ans: D. Pregnant women,
prisoners, children
The NBAC looks at characteristics individuals might have that would
prevent them from being able to provide voluntary informed consent. The
traits may be thought of as falling into six broad areas: cognitive or
communicative, institutional, deferential, medical, economic, and social.
Prospective research subjects who are not able to comprehend
information, deliberate, and make decisions about participation in a
proposed research study have a:
A. Institutional vulnerability
B. Cognitive or communicative vulnerability
C. Physical vulnerability
D. Economic or social vulnerability Ans: B. Cognitive or communicative
vulnerability
The use of prisoners in research is a concern under the Belmont principle
of Justice because:
A. Prisoners are less educated that the general population and have
difficulty understanding research
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B. Prisoners may not be used to conduct research that only benefits the
larger society
C. Prisoners are not a representative sample of the general population
D. Prisoners are not free to say no Ans: B. Prisoners may not be used to
conduct research that only benefits the larger society
Which of the following is included in the Nuremberg Code:
A. Additional protection for vulnerable subjects
B. Equitable selection of subjects
C. Confidentiality of data
D. Voluntary consent Ans: D. Voluntary consent
Which of the following brought increased public attention to the problems
with the IRB system?
A. 1983 Presidential Commission Report
B. HHS Inspector General Report of 1998
C. "Shut Downs" by OHRP
D. Death of Research Subject (Jesse Gelsinger) Ans: D. Death of
Research Subject (Jesse Gelsinger)
Informed consent is considered an application of which Belmont principle?
A. Non-maleficence
B. Justice
C. Beneficence
D. Respect for Persons Ans: D. Respect for Persons
CITI TRAINING, MODULES 1-24
(BIOMEDICAL RESEARCH) QUESTIONS
WITH DETAILED VERIFIED ANSWERS
The Belmont Report's principle of respect for persons incorporates at
least two ethical convictions: first, that individuals should be treated as
autonomous agents, and second, that:
A. Persons with diminished autonomy should only participate in no more
than minimal risk research.
B. Persons with diminished autonomy should be excluded from research.
C. Persons with diminished autonomy are entitled to protection.
D. Persons involved in research cannot financially benefit. Ans: C.
Persons with diminished autonomy are entitled to protection.
Which of the following is an example of how the principle of beneficence
can be applied to a study employing human subjects?
A. Ensuring that persons with diminished autonomy are protected.
B. Providing detailed information about the study and obtaining the
subject's consent to participate.
C. Determining that the study has a maximization of benefits and a
minimization of risks.
D. Ensuring that the selection of subjects includes people from all
segments of the population. Ans: C. Determining that the study has a
maximization of benefits and a minimization of risks.
Which of the following are the three principles discussed in the Belmont
Report?
A. IRB Review, Federal Regulations, Declaration of Helsinki
, Page | 2
B. Privacy, Confidentiality, Equitable Selection of Subjects
C. Informed Consent, Institutional Assurance, Researcher Responsibility
D. Respect for Persons, Beneficence, Justice Ans: D. Respect for
Persons, Beneficence, Justice
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. Has the researcher completed required training?
D. Are the research procedures greater than minimal risk of harm? Ans:
B. Is there a power differential between researchers and subjects?
Which is an example of a situation where deferential vulnerability might
be a factor?
A. An army medical officer recruiting subjects among lower ranks
B. A college professor recruiting among their students
C. A physician recruiting patients to be subjects
D. An employer recruiting among persons who directly report to them
Ans: C. A physician recruiting patients to be subjects
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. Situational cognitive vulnerability
C. Capacity-related cognitive vulnerability
, Page | 3
D. Communicative vulnerability Ans: B. Situational cognitive
vulnerability
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, and mentally disabled
B. Children, prisoners, and terminally ill
C. Prisoners, children, and elderly
D. Pregnant women, prisoners, children Ans: D. Pregnant women,
prisoners, children
The NBAC looks at characteristics individuals might have that would
prevent them from being able to provide voluntary informed consent. The
traits may be thought of as falling into six broad areas: cognitive or
communicative, institutional, deferential, medical, economic, and social.
Prospective research subjects who are not able to comprehend
information, deliberate, and make decisions about participation in a
proposed research study have a:
A. Institutional vulnerability
B. Cognitive or communicative vulnerability
C. Physical vulnerability
D. Economic or social vulnerability Ans: B. Cognitive or communicative
vulnerability
The use of prisoners in research is a concern under the Belmont principle
of Justice because:
A. Prisoners are less educated that the general population and have
difficulty understanding research
, Page | 4
B. Prisoners may not be used to conduct research that only benefits the
larger society
C. Prisoners are not a representative sample of the general population
D. Prisoners are not free to say no Ans: B. Prisoners may not be used to
conduct research that only benefits the larger society
Which of the following is included in the Nuremberg Code:
A. Additional protection for vulnerable subjects
B. Equitable selection of subjects
C. Confidentiality of data
D. Voluntary consent Ans: D. Voluntary consent
Which of the following brought increased public attention to the problems
with the IRB system?
A. 1983 Presidential Commission Report
B. HHS Inspector General Report of 1998
C. "Shut Downs" by OHRP
D. Death of Research Subject (Jesse Gelsinger) Ans: D. Death of
Research Subject (Jesse Gelsinger)
Informed consent is considered an application of which Belmont principle?
A. Non-maleficence
B. Justice
C. Beneficence
D. Respect for Persons Ans: D. Respect for Persons
