CITI TRAINING ACTUAL EXAM
QUESTIONS WITH CORRECT
VERIFIED SOLUTIONS FOR
ACCURACY ALREADY GRADED A+
LATEST VERSION 2026
"Which is true of inducements in research? - CORRECT ANSWER=> Inducements constitute an
"undue influence" if they alter a potential subject's decision-making processes, such that they
do not appropriately weigh the risk-benefit relationship of the research."
"NBAC proposed a concept of vulnerability in research based on features of potential subjects
or of their situation. Which of the following was not included as possibly leading to
vulnerability? - CORRECT ANSWER=> High potential for individual benefit from participating in
research"
"According to the authors, there are four common abuses that historically are described as
giving rise to vulnerability . Which response below contains the correct four? - CORRECT
ANSWER=> Physical control, coercion, undue influence, and manipulation"
"Which of the following was the result of the Beecher article? - CORRECT ANSWER=> Realization
that ethical abuses are not limited to the Nazi regime"
"The use of prisoners in research is a concern under the Belmont principle of Justice because: -
CORRECT ANSWER=> Prisoners may be used to conduct research that only benefits the larger
society"
"The National Research Act of 1974 - CORRECT ANSWER=> Established the National Commission."
"Which of the following is included in the Nuremberg Code: - CORRECT ANSWER=> Voluntary
consent"
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,"Issued in 1974, 45 CFR 46 raised to regulatory status - CORRECT ANSWER=> US Public Health
Service Policy"
"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? - CORRECT ANSWER=> 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? - CORRECT ANSWER=> 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? - CORRECT ANSWER=> 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: -
CORRECT ANSWER=> 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: - CORRECT ANSWER=> Occur at least annually."
"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 becomes commercially available that may
have equal or greater benefit to the subject. The investigator should do which of the following?
- CORRECT ANSWER=> Give the subject comprehensive information about the new drug,
including its side effects. Discuss the pros and cons of both the investigational drug and the
commercially available drug and then allow the subject to decide whether to withdraw from the
research to take the new drug."
"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
Page | 2
,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? - CORRECT
ANSWER=> 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."
"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: - CORRECT ANSWER=> 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."
"The purpose of informed consent is: - CORRECT ANSWER=> 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 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? - CORRECT ANSWER=> I waive any possibility of compensation for injuries that I may
receive as a result of participation in this research."
"A researcher is conducting a written survey about people's attitudes toward walking as an
exercise option at the local shopping mall that supports a walking program. The survey is
anonymous (without codes, names, or other information) and subjects may complete the
survey and place it in a box at the shopping mall exits. Which of the following is the most
important issue that the researcher addressed in planning the research? - CORRECT ANSWER=>
Confidentiality of the individual subject's responses"
"A researcher wants to invite therapists to participate in small focus groups to discuss their
perceptions regarding "troubled" adolescent girls and the relationships they have with their
parents. Specific clients of the therapists will not be discussed. Which of the following will be
Page | 3
, the most important issue for the researcher to consider when planning the research? - CORRECT
ANSWER=> Breach of confidentiality from the focus group subjects (therapists)"
"Which of the following most accurately describes the risks associated with SBR? - CORRECT
ANSWER=> Less predictable, more variable, and less treatable than physical harms"
"Which of the following is considered a SBR data collection method? - CORRECT ANSWER=>
Interviews"
"A researcher wants to conduct a secondary analysis using a Centers for Disease Control and
Prevention (CDC) database that was collected by the agency solely for surveillance purposes
from 1996-2006. The researcher did not participate in the initial collection of the data. The
database is publicly available. The database does not include any identifiers. The IRB makes a
determination that the individuals whose records will be reviewed do not meet the federal
definition of human subjects.
Which of the following considerations was relevant to the IRB's determination that this activity
does not constitute research with human subjects? - CORRECT ANSWER=> The researcher will not
be interacting/intervening with subjects and the data has no identifiers."
"An investigator obtains consent and HIPAA authorization from subjects to review their medical
records and HIV status. He plans to go back to the medical record, so the HIV status information
is stored along with subject identifiers in a database that he keeps on his laptop computer. His
laptop is stolen. This incident constitutes: - CORRECT ANSWER=> A breach of confidentiality"
"As part of a research study, a physician plans to review medical records to explore factors
related to 50 of her patients who require magnetic resonance imaging (MRI) scans for clinical
treatment. The physician will review the medical records, and write down the clinical indication
for the scans, any existing injuries, current prescriptions, as well as other clinical data. The
clinical indication for the scans and the other clinical data will be collected in the medical
records for treatment purposes as part of standard clinical care. The physician will use a coding
system to be able to identify the patient's information; however, the "key" to the coding system
will be stored separately from the data in a locked cabinet that only she will have access to.
Which of the following is true? - CORRECT ANSWER=> The study is human subject research which
is eligible for expedited review."
"A sponsor proposes research to evaluate reengineering a commercially available pacemaker. It
is hoped that the new pacemaker will pose fewer risks to individuals when compared to the
Page | 4
QUESTIONS WITH CORRECT
VERIFIED SOLUTIONS FOR
ACCURACY ALREADY GRADED A+
LATEST VERSION 2026
"Which is true of inducements in research? - CORRECT ANSWER=> Inducements constitute an
"undue influence" if they alter a potential subject's decision-making processes, such that they
do not appropriately weigh the risk-benefit relationship of the research."
"NBAC proposed a concept of vulnerability in research based on features of potential subjects
or of their situation. Which of the following was not included as possibly leading to
vulnerability? - CORRECT ANSWER=> High potential for individual benefit from participating in
research"
"According to the authors, there are four common abuses that historically are described as
giving rise to vulnerability . Which response below contains the correct four? - CORRECT
ANSWER=> Physical control, coercion, undue influence, and manipulation"
"Which of the following was the result of the Beecher article? - CORRECT ANSWER=> Realization
that ethical abuses are not limited to the Nazi regime"
"The use of prisoners in research is a concern under the Belmont principle of Justice because: -
CORRECT ANSWER=> Prisoners may be used to conduct research that only benefits the larger
society"
"The National Research Act of 1974 - CORRECT ANSWER=> Established the National Commission."
"Which of the following is included in the Nuremberg Code: - CORRECT ANSWER=> Voluntary
consent"
Page | 1
,"Issued in 1974, 45 CFR 46 raised to regulatory status - CORRECT ANSWER=> US Public Health
Service Policy"
"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? - CORRECT ANSWER=> 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? - CORRECT ANSWER=> 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? - CORRECT ANSWER=> 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: -
CORRECT ANSWER=> 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: - CORRECT ANSWER=> Occur at least annually."
"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 becomes commercially available that may
have equal or greater benefit to the subject. The investigator should do which of the following?
- CORRECT ANSWER=> Give the subject comprehensive information about the new drug,
including its side effects. Discuss the pros and cons of both the investigational drug and the
commercially available drug and then allow the subject to decide whether to withdraw from the
research to take the new drug."
"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
Page | 2
,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? - CORRECT
ANSWER=> 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."
"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: - CORRECT ANSWER=> 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."
"The purpose of informed consent is: - CORRECT ANSWER=> 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 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? - CORRECT ANSWER=> I waive any possibility of compensation for injuries that I may
receive as a result of participation in this research."
"A researcher is conducting a written survey about people's attitudes toward walking as an
exercise option at the local shopping mall that supports a walking program. The survey is
anonymous (without codes, names, or other information) and subjects may complete the
survey and place it in a box at the shopping mall exits. Which of the following is the most
important issue that the researcher addressed in planning the research? - CORRECT ANSWER=>
Confidentiality of the individual subject's responses"
"A researcher wants to invite therapists to participate in small focus groups to discuss their
perceptions regarding "troubled" adolescent girls and the relationships they have with their
parents. Specific clients of the therapists will not be discussed. Which of the following will be
Page | 3
, the most important issue for the researcher to consider when planning the research? - CORRECT
ANSWER=> Breach of confidentiality from the focus group subjects (therapists)"
"Which of the following most accurately describes the risks associated with SBR? - CORRECT
ANSWER=> Less predictable, more variable, and less treatable than physical harms"
"Which of the following is considered a SBR data collection method? - CORRECT ANSWER=>
Interviews"
"A researcher wants to conduct a secondary analysis using a Centers for Disease Control and
Prevention (CDC) database that was collected by the agency solely for surveillance purposes
from 1996-2006. The researcher did not participate in the initial collection of the data. The
database is publicly available. The database does not include any identifiers. The IRB makes a
determination that the individuals whose records will be reviewed do not meet the federal
definition of human subjects.
Which of the following considerations was relevant to the IRB's determination that this activity
does not constitute research with human subjects? - CORRECT ANSWER=> The researcher will not
be interacting/intervening with subjects and the data has no identifiers."
"An investigator obtains consent and HIPAA authorization from subjects to review their medical
records and HIV status. He plans to go back to the medical record, so the HIV status information
is stored along with subject identifiers in a database that he keeps on his laptop computer. His
laptop is stolen. This incident constitutes: - CORRECT ANSWER=> A breach of confidentiality"
"As part of a research study, a physician plans to review medical records to explore factors
related to 50 of her patients who require magnetic resonance imaging (MRI) scans for clinical
treatment. The physician will review the medical records, and write down the clinical indication
for the scans, any existing injuries, current prescriptions, as well as other clinical data. The
clinical indication for the scans and the other clinical data will be collected in the medical
records for treatment purposes as part of standard clinical care. The physician will use a coding
system to be able to identify the patient's information; however, the "key" to the coding system
will be stored separately from the data in a locked cabinet that only she will have access to.
Which of the following is true? - CORRECT ANSWER=> The study is human subject research which
is eligible for expedited review."
"A sponsor proposes research to evaluate reengineering a commercially available pacemaker. It
is hoped that the new pacemaker will pose fewer risks to individuals when compared to the
Page | 4
