CITI Training Quiz Questions
1. Which of the following are the three principles discussed in the Belmont Report? -
ANS - Respect for Persons, Beneficence, Justice
2. 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: - ANS - Persons with diminished autonomy are entitled to protection.
3. Which of the following is an example of how the principle of beneficence can be
applied to a study employing human subjects? - ANS - Determining that the study has
a maximization of benefits and a minimization of risks.
4. The Data Manager should review the study protocol: - ANS - to understand primary
and secondary endpoints
5. When designing a database and data collection instruments for a study, the Data
Manager should: - ANS - Use standards to reduce the time required to set up the
database and to increase the consistency of the data
A 46-year-old man is currently enrolled in a Phase III study of a drug for severe diabetic
neuropathy. While the study is ongoing, a new drug becomes commercially available
that may have equal or greater benefit to the subject. The investigator should do which
of the following?
A. 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.
B. Tell the subject about the new drug but discourage him from switching treatments
until the study is completed
C. Withhold this new information to avoid confusing the subject with other treatment
options or alternatives
D. Do not tell the subject about the new drug since physicians have the right to try out
new treatments with their patients - ANS - 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.
, 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? - ANS - The researcher will
not be interacting/intervening with subjects and the data has no identifiers.
According to U.S. Federal Research Misconduct Policy, which of the following is
considered to be research misconduct?
A. Gift authorship
B. Plagiarism
C. Conflict of interest
D. Harassing a co-worker - ANS - B. Plagiarism
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 for the individual's legal representative. Under the FDA
regulations, which of the following describes the best course of action for the
investigator:
A. Do not use the test article until either the subject or the subject's legally authorized
representative can give consent.
B. Submit a research protocol to the IRB and justify an expedited review approval of the
consent document so the test article can be used immediately.
C. The investigator and another physician not part of the study team agree that the
situation necessitates the use of the test article and the IRB will be notified later.
D. Sign the consent form on behalf of the subject and use the test article. - ANS - The
investigator and another physician not part of the study team agree that the situation
necessitates the use of the test article and the IRB will be notified later.
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
1. Which of the following are the three principles discussed in the Belmont Report? -
ANS - Respect for Persons, Beneficence, Justice
2. 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: - ANS - Persons with diminished autonomy are entitled to protection.
3. Which of the following is an example of how the principle of beneficence can be
applied to a study employing human subjects? - ANS - Determining that the study has
a maximization of benefits and a minimization of risks.
4. The Data Manager should review the study protocol: - ANS - to understand primary
and secondary endpoints
5. When designing a database and data collection instruments for a study, the Data
Manager should: - ANS - Use standards to reduce the time required to set up the
database and to increase the consistency of the data
A 46-year-old man is currently enrolled in a Phase III study of a drug for severe diabetic
neuropathy. While the study is ongoing, a new drug becomes commercially available
that may have equal or greater benefit to the subject. The investigator should do which
of the following?
A. 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.
B. Tell the subject about the new drug but discourage him from switching treatments
until the study is completed
C. Withhold this new information to avoid confusing the subject with other treatment
options or alternatives
D. Do not tell the subject about the new drug since physicians have the right to try out
new treatments with their patients - ANS - 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.
, 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? - ANS - The researcher will
not be interacting/intervening with subjects and the data has no identifiers.
According to U.S. Federal Research Misconduct Policy, which of the following is
considered to be research misconduct?
A. Gift authorship
B. Plagiarism
C. Conflict of interest
D. Harassing a co-worker - ANS - B. Plagiarism
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 for the individual's legal representative. Under the FDA
regulations, which of the following describes the best course of action for the
investigator:
A. Do not use the test article until either the subject or the subject's legally authorized
representative can give consent.
B. Submit a research protocol to the IRB and justify an expedited review approval of the
consent document so the test article can be used immediately.
C. The investigator and another physician not part of the study team agree that the
situation necessitates the use of the test article and the IRB will be notified later.
D. Sign the consent form on behalf of the subject and use the test article. - ANS - The
investigator and another physician not part of the study team agree that the situation
necessitates the use of the test article and the IRB will be notified later.
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
