CITI Training, Modules 1-24 (Biomedical Research)with complete
Questions and 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:
A. They only involve changes to the consent form.
B. The changes must be immediately implemented for the health and well-being of the
subject.
C. They are eligible for review using expedited procedures.
D. The investigator keeps careful records of all changes and includes them in the final
report. - correct answer B. The changes must be immediately implemented for the
health and well-being of the subject.
IRB continuing review of a greater than minimal risk approved protocol that is currently
enrolling subjects must:
A. Include copies of all signed consent forms.
B. Occur at least annually.
C. Be conducted by an expedited review.
D. Occur only when the level of risk changes. - correct answer B. Occur at least
annually.
A general requirement for the informed consent form is that it may not include any
exculpatory language. Exculpatory language is that which waives or appears to waive
any of the subject's legal rights or releases or appears to release those conducting the
research from liability for negligence. Which of the following statements in a consent
form is an example of exculpatory language?
A. In the event of any injury you may have related to this research, you will be given
medical treatment.
B. Your participation in this research is voluntary. If you choose not to participate, or
change your mind later, your decision will not affect your relationship with your doctor or
your right to health care or other services that you may be eligible for.
C. The investigator may stop you from participating in this research without your
consent if you experience side effects that make your condition worse. If you become ill
during the research, you may have to drop out.
D. I waive any possibility of compensation for injuries that I may receive as a result of
participation in this research. - correct answer D. I waive any possibility of compensation
for injuries that I may receive as a result of participation in this research.
An investigator is confronted with a life-threatening situation that necessitates using a
test article in a human subject who is unable to provide informed consent and there is
no time to obtain consent from the individual's LAR and no alternative method or
recognized therapy is available. Under the FDA regulations for using test articles, which
of the following describes the best course of action for the investigator:
A. Submit A Research Protocol To The IRB And Justify An Expedited Review Approval
Of The Consent Document So Test Article Can Be Used Immediately.
Questions and 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:
A. They only involve changes to the consent form.
B. The changes must be immediately implemented for the health and well-being of the
subject.
C. They are eligible for review using expedited procedures.
D. The investigator keeps careful records of all changes and includes them in the final
report. - correct answer B. The changes must be immediately implemented for the
health and well-being of the subject.
IRB continuing review of a greater than minimal risk approved protocol that is currently
enrolling subjects must:
A. Include copies of all signed consent forms.
B. Occur at least annually.
C. Be conducted by an expedited review.
D. Occur only when the level of risk changes. - correct answer B. Occur at least
annually.
A general requirement for the informed consent form is that it may not include any
exculpatory language. Exculpatory language is that which waives or appears to waive
any of the subject's legal rights or releases or appears to release those conducting the
research from liability for negligence. Which of the following statements in a consent
form is an example of exculpatory language?
A. In the event of any injury you may have related to this research, you will be given
medical treatment.
B. Your participation in this research is voluntary. If you choose not to participate, or
change your mind later, your decision will not affect your relationship with your doctor or
your right to health care or other services that you may be eligible for.
C. The investigator may stop you from participating in this research without your
consent if you experience side effects that make your condition worse. If you become ill
during the research, you may have to drop out.
D. I waive any possibility of compensation for injuries that I may receive as a result of
participation in this research. - correct answer D. I waive any possibility of compensation
for injuries that I may receive as a result of participation in this research.
An investigator is confronted with a life-threatening situation that necessitates using a
test article in a human subject who is unable to provide informed consent and there is
no time to obtain consent from the individual's LAR and no alternative method or
recognized therapy is available. Under the FDA regulations for using test articles, which
of the following describes the best course of action for the investigator:
A. Submit A Research Protocol To The IRB And Justify An Expedited Review Approval
Of The Consent Document So Test Article Can Be Used Immediately.
