CITI TRAINING QUIZ ACTUAL QUESTIONS
WITH VERIFIED SOLUTIONS
◉ 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
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
,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.
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.
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
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
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.
WITH VERIFIED SOLUTIONS
◉ 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
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
,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.
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.
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
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
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.
