CITI Training, Modules 1-24 (Biomedical Research) / Newest Actual
CITI Training, Modules 1-24 (Biomedical Research)
Exam Review Q&A with Definitive Answers / A+ Score Solutions.
Study online at https://quizlet.com/_awiraf
1. The Belmont Report's principle of respect for persons C. Persons with dimin-
incorporates at least two ethical convictions: first, that ished autonomy are enti-
individuals should be treated as autonomous agents, tled to protection.
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 ex-
cluded from research.
C. Persons with diminished autonomy are entitled to
protection.
D. Persons involved in research cannot financially ben-
efit.
2. Which of the following is an example of how the prin- C. Determining that the
ciple of beneficence can be applied to a study employ- study has a maximization
ing human subjects? of benefits and a mini-
A. Ensuring that persons with diminished autonomy mization of risks.
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.
3. Which of the following are the three principles dis- D. Respect for Persons,
cussed in the Belmont Report? Beneficence, Justice
A. IRB Review, Federal Regulations, Declaration of
Helsinki
B. Privacy, Confidentiality, Equitable Selection of Sub-
jects
C. Informed Consent, Institutional Assurance, Re-
, CITI Training, Modules 1-24 (Biomedical Research)
Study online at https://quizlet.com/_awiraf
searcher Responsibility
D. Respect for Persons, Beneficence, Justice
4. When an IRB is reviewing a research study and they B. Is there a power
are considering if a potential subject population is differential between re-
vulnerable, they should consider: searchers and subjects?
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?
5. Which is an example of a situation where deferential C. A physician recruiting
vulnerability might be a factor? patients to be subjects
A. An army medical officer recruiting subjects among
lower ranks
B. A college professor recruiting among their stu-
dents
C. A physician recruiting patients to be subjects
D. An employer recruiting among persons who direct-
ly report to them
6. In considering NBAC's analytic approach, an other- B. Situational cognitive
wise competent person who is acutely ill might be vulnerability
considered at especially high risk of harm for:
A. Economic vulnerability
B. Situational cognitive vulnerability
C. Capacity-related cognitive vulnerability
D. Communicative vulnerability
7.
, CITI Training, Modules 1-24 (Biomedical Research)
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Identify the following groups that are protected in the D. Pregnant women, pris-
federal regulations (45 CFR 46), specifically in Subparts oners, children
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
8. The NBAC looks at characteristics individuals might B. Cognitive or commu-
have that would prevent them from being able to nicative vulnerability
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, delib-
erate, 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
9. The use of prisoners in research is a concern under B. Prisoners may not be
the Belmont principle of Justice because: used to conduct research
A. Prisoners are less educated that the general popu- that only benefits the larg-
lation and have difficulty understanding research er society
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
, CITI Training, Modules 1-24 (Biomedical Research)
Study online at https://quizlet.com/_awiraf
10. Which of the following is included in the Nuremberg D. Voluntary consent
Code:
A. Additional protection for vulnerable subjects
B. Equitable selection of subjects
C. Confidentiality of data
D. Voluntary consent
11. Which of the following brought increased public atten- D. Death of Research Sub-
tion to the problems with the IRB system? ject (Jesse Gelsinger)
A. 1983 Presidential Commission Report
B. HHS Inspector General Report of 1998
C. "Shut Downs" by OHRP
D. Death of Research Subject (Jesse Gelsinger)
12. Informed consent is considered an application of D. Respect for Persons
which Belmont principle?
A. Non-maleficence
B. Justice
C. Beneficence
D. Respect for Persons
13. The National Research Act of 1974 C. Established the Nation-
A. Required that all federal agencies have the same al Commission.
regulations governing human subjects research.
B. Identified guidelines to ensure the ethical conduct
of research.
C. Established the National Commission.
D. Identified the basic ethical principles of human sub-
jects research.
14. A subject in a clinical research trial experiences a se- A. Report the adverse drug
rious, unanticipated adverse drug experience. How experience in a timely
should the investigator proceed, with respect to the manner, in keeping with
CITI Training, Modules 1-24 (Biomedical Research)
Exam Review Q&A with Definitive Answers / A+ Score Solutions.
Study online at https://quizlet.com/_awiraf
1. The Belmont Report's principle of respect for persons C. Persons with dimin-
incorporates at least two ethical convictions: first, that ished autonomy are enti-
individuals should be treated as autonomous agents, tled to protection.
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 ex-
cluded from research.
C. Persons with diminished autonomy are entitled to
protection.
D. Persons involved in research cannot financially ben-
efit.
2. Which of the following is an example of how the prin- C. Determining that the
ciple of beneficence can be applied to a study employ- study has a maximization
ing human subjects? of benefits and a mini-
A. Ensuring that persons with diminished autonomy mization of risks.
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.
3. Which of the following are the three principles dis- D. Respect for Persons,
cussed in the Belmont Report? Beneficence, Justice
A. IRB Review, Federal Regulations, Declaration of
Helsinki
B. Privacy, Confidentiality, Equitable Selection of Sub-
jects
C. Informed Consent, Institutional Assurance, Re-
, CITI Training, Modules 1-24 (Biomedical Research)
Study online at https://quizlet.com/_awiraf
searcher Responsibility
D. Respect for Persons, Beneficence, Justice
4. When an IRB is reviewing a research study and they B. Is there a power
are considering if a potential subject population is differential between re-
vulnerable, they should consider: searchers and subjects?
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?
5. Which is an example of a situation where deferential C. A physician recruiting
vulnerability might be a factor? patients to be subjects
A. An army medical officer recruiting subjects among
lower ranks
B. A college professor recruiting among their stu-
dents
C. A physician recruiting patients to be subjects
D. An employer recruiting among persons who direct-
ly report to them
6. In considering NBAC's analytic approach, an other- B. Situational cognitive
wise competent person who is acutely ill might be vulnerability
considered at especially high risk of harm for:
A. Economic vulnerability
B. Situational cognitive vulnerability
C. Capacity-related cognitive vulnerability
D. Communicative vulnerability
7.
, CITI Training, Modules 1-24 (Biomedical Research)
Study online at https://quizlet.com/_awiraf
Identify the following groups that are protected in the D. Pregnant women, pris-
federal regulations (45 CFR 46), specifically in Subparts oners, children
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
8. The NBAC looks at characteristics individuals might B. Cognitive or commu-
have that would prevent them from being able to nicative vulnerability
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, delib-
erate, 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
9. The use of prisoners in research is a concern under B. Prisoners may not be
the Belmont principle of Justice because: used to conduct research
A. Prisoners are less educated that the general popu- that only benefits the larg-
lation and have difficulty understanding research er society
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
, CITI Training, Modules 1-24 (Biomedical Research)
Study online at https://quizlet.com/_awiraf
10. Which of the following is included in the Nuremberg D. Voluntary consent
Code:
A. Additional protection for vulnerable subjects
B. Equitable selection of subjects
C. Confidentiality of data
D. Voluntary consent
11. Which of the following brought increased public atten- D. Death of Research Sub-
tion to the problems with the IRB system? ject (Jesse Gelsinger)
A. 1983 Presidential Commission Report
B. HHS Inspector General Report of 1998
C. "Shut Downs" by OHRP
D. Death of Research Subject (Jesse Gelsinger)
12. Informed consent is considered an application of D. Respect for Persons
which Belmont principle?
A. Non-maleficence
B. Justice
C. Beneficence
D. Respect for Persons
13. The National Research Act of 1974 C. Established the Nation-
A. Required that all federal agencies have the same al Commission.
regulations governing human subjects research.
B. Identified guidelines to ensure the ethical conduct
of research.
C. Established the National Commission.
D. Identified the basic ethical principles of human sub-
jects research.
14. A subject in a clinical research trial experiences a se- A. Report the adverse drug
rious, unanticipated adverse drug experience. How experience in a timely
should the investigator proceed, with respect to the manner, in keeping with
