CITI Training, Modules 1-24 (Biomedical Research) |
136 Questions with 100% Correct 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. Correct 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.
D. Ensuring that the selection of subjects includes people from all segments of the population.
Correct Answer: 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
B. Privacy, Confidentiality, Equitable Selection of Subjects
C. Informed Consent, Institutional Assurance, Researcher Responsibility
D. Respect for Persons, Beneficence, Justice Correct Answer: 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? Correct Answer: 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 Correct Answer: 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
D. Communicative vulnerability Correct 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 Correct 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 Correct 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 Correct 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 Correct 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) Correct 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 Correct Answer: D. Respect for Persons
The National Research Act of 1974
A. Required that all federal agencies have the same 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 subjects research. Correct Answer: C.
Established the National Commission.
A subject in a clinical research trial experiences a serious, unanticipated adverse drug
experience. How should the investigator proceed, with respect to the IRB, after the discovery of
the adverse event occurrence?
A. Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and
procedures, using the forms or the mechanism provided by the IRB.
B. Report the adverse drug experience as part of the continuing review report.
C. Do not report the adverse drug experience to the IRB since it is a common adverse
experience.
D. Report the adverse drug experience to the IRB only if there are several other occurrences.
Correct Answer: A. Report the adverse drug experience in a timely manner, in keeping with the
IRB's policies and procedures, using the forms or the mechanism provided by the IRB.
How long is an investigator required to keep consent documents, IRB correspondence, and
research records?
A. As long as the investigator is at that institution
B. For a minimum of three years after completion of the study
C. Until data analysis is complete
D. Until the study is closed Correct Answer: B. For a minimum of three years after completion
of the study
According to federal regulations, which of the following best describes when expedited review
of a new, proposed study may be used by the IRB?
A. The study is required for a student research project
B. The study includes only research subjects that are healthy volunteers.
C. The study does not require informed consent or survey instruments.
D. The study involves no more than minimal risk and meets one of the allowable categories of
expedited review specified in federal regulations Correct Answer: D. The study involves no
more than minimal risk and meets one of the allowable categories of expedited review specified
in federal regulations
Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if:
136 Questions with 100% Correct 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. Correct 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.
D. Ensuring that the selection of subjects includes people from all segments of the population.
Correct Answer: 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
B. Privacy, Confidentiality, Equitable Selection of Subjects
C. Informed Consent, Institutional Assurance, Researcher Responsibility
D. Respect for Persons, Beneficence, Justice Correct Answer: 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? Correct Answer: 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 Correct Answer: 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
D. Communicative vulnerability Correct 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 Correct 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 Correct 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 Correct 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 Correct 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) Correct 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 Correct Answer: D. Respect for Persons
The National Research Act of 1974
A. Required that all federal agencies have the same 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 subjects research. Correct Answer: C.
Established the National Commission.
A subject in a clinical research trial experiences a serious, unanticipated adverse drug
experience. How should the investigator proceed, with respect to the IRB, after the discovery of
the adverse event occurrence?
A. Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and
procedures, using the forms or the mechanism provided by the IRB.
B. Report the adverse drug experience as part of the continuing review report.
C. Do not report the adverse drug experience to the IRB since it is a common adverse
experience.
D. Report the adverse drug experience to the IRB only if there are several other occurrences.
Correct Answer: A. Report the adverse drug experience in a timely manner, in keeping with the
IRB's policies and procedures, using the forms or the mechanism provided by the IRB.
How long is an investigator required to keep consent documents, IRB correspondence, and
research records?
A. As long as the investigator is at that institution
B. For a minimum of three years after completion of the study
C. Until data analysis is complete
D. Until the study is closed Correct Answer: B. For a minimum of three years after completion
of the study
According to federal regulations, which of the following best describes when expedited review
of a new, proposed study may be used by the IRB?
A. The study is required for a student research project
B. The study includes only research subjects that are healthy volunteers.
C. The study does not require informed consent or survey instruments.
D. The study involves no more than minimal risk and meets one of the allowable categories of
expedited review specified in federal regulations Correct Answer: D. The study involves no
more than minimal risk and meets one of the allowable categories of expedited review specified
in federal regulations
Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if:
