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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
D. Communicative vulnerability - ANSWER-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 - ANSWER-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 - ANSWER-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
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 - ANSWER-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 - ANSWER-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) - ANSWER-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 - ANSWER-D. Respect for Persons
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. - ANSWER-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.