CITI TRAINING, MODULES 1-24
BIOMEDICAL RESEARCH Exam
Questions with 100% Correct Answers
2025 Graded A+
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.
B. Use the test article without obtaining consent from the subject or the LAR then notify
the IRB.
C. The investigator and an independent physician agree that the situation necessitates
the use of the test article. An exception or waiver for informed consent can be made
under these circumstances. The IRB will be notified later.
D. Do not use the test article until either the subject or the subject's LAR can give
consent. - correct answer C. The investigator and an independent physician agree that
the situation necessitates the use of the test article. An exception or waiver for informed
consent can be made under these circumstances. The IRB will be notified later.
An elderly gentleman, whose wife is his legally authorized representative (LAR) since
his strokes several years ago, was recently diagnosed with lung cancer. He is eligible
for a clinical trial using a new investigational drug that aims to treat lung cancer. He is
able to express interest, shows a basic understanding of the nature of the trial, and
gives his assent to participation. The subject's wife is out of town on a business trip.
Which of the following is the most appropriate action to take for the investigator?
A. Send a copy of the informed consent via facsimile to the subject's wife. After she has
had the opportunity to speak to the investigator, she can sign the informed consent and
fax it back.
B. Exclude the man from the study.
C. Consult a colleague about his opinion. If the colleague agrees, enroll the man without
a signed consent.
D. The investigator can go ahead and enroll the man without a signed consent. - correct
answer A. Send a copy of the informed consent via facsimile to the subject's wife. After
BIOMEDICAL RESEARCH Exam
Questions with 100% Correct Answers
2025 Graded A+
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.
B. Use the test article without obtaining consent from the subject or the LAR then notify
the IRB.
C. The investigator and an independent physician agree that the situation necessitates
the use of the test article. An exception or waiver for informed consent can be made
under these circumstances. The IRB will be notified later.
D. Do not use the test article until either the subject or the subject's LAR can give
consent. - correct answer C. The investigator and an independent physician agree that
the situation necessitates the use of the test article. An exception or waiver for informed
consent can be made under these circumstances. The IRB will be notified later.
An elderly gentleman, whose wife is his legally authorized representative (LAR) since
his strokes several years ago, was recently diagnosed with lung cancer. He is eligible
for a clinical trial using a new investigational drug that aims to treat lung cancer. He is
able to express interest, shows a basic understanding of the nature of the trial, and
gives his assent to participation. The subject's wife is out of town on a business trip.
Which of the following is the most appropriate action to take for the investigator?
A. Send a copy of the informed consent via facsimile to the subject's wife. After she has
had the opportunity to speak to the investigator, she can sign the informed consent and
fax it back.
B. Exclude the man from the study.
C. Consult a colleague about his opinion. If the colleague agrees, enroll the man without
a signed consent.
D. The investigator can go ahead and enroll the man without a signed consent. - correct
answer A. Send a copy of the informed consent via facsimile to the subject's wife. After
