CITI Training, Modules 1-24 (Biomedical
Research) Questions With 100% 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 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. - 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. - 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. - ANSWER 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.
The purpose of informed consent is:
A. To provide a potential subject with appropriate information in an
appropriate manner and allow that person to make an informed decision
about participation in research.
B. To obtain a signature from a study subject in order to protect the
investigator, the study staff and the institution.
C. To obtain a signature from a study subject in order to document his or
her agreement to participate in research.
D. To document the investigator's participation in the consent process. -
ANSWER A. To provide a potential subject with appropriate information in
an appropriate manner and allow that person to make an informed decision
about participation in research.
A 46-year-old man is currently enrolled in a Phase 2 study of a drug for
severe diabetic neuropathy. While the study is on-going, a new drug
Research) Questions With 100% 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 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. - 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. - 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. - ANSWER 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.
The purpose of informed consent is:
A. To provide a potential subject with appropriate information in an
appropriate manner and allow that person to make an informed decision
about participation in research.
B. To obtain a signature from a study subject in order to protect the
investigator, the study staff and the institution.
C. To obtain a signature from a study subject in order to document his or
her agreement to participate in research.
D. To document the investigator's participation in the consent process. -
ANSWER A. To provide a potential subject with appropriate information in
an appropriate manner and allow that person to make an informed decision
about participation in research.
A 46-year-old man is currently enrolled in a Phase 2 study of a drug for
severe diabetic neuropathy. While the study is on-going, a new drug
