CITI TRAINING QUIZ LATEST 2025/2026 QUESTIONS
AND ANSWERS
1. Which of the following are the three principles discussed in the Belmont Report? - ANSWER-
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: - ANSWER-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? - ANSWER-Determining that the study has a maximization of benefits and
a minimization of risks.
4. The Data Manager should review the study protocol: - ANSWER-to understand primary and
secondary endpoints
5. When designing a database and data collection instruments for a study, the Data Manager should: -
ANSWER-Use standards to reduce the time required to set up the database and to increase the
consistency of the data
Every member of a study team must define quality the same way in order to produce a high quality
database. - ANSWER-False
Which member of a study team is ultimately responsible for the conduct of the study at a site? -
ANSWER-The Investigator
Which member of a study team acts as the liaison between a sponsor and site, ensuring that reported
data are verifiable to source documentation? - ANSWER-The Clinical Research Associate
In order for a quality process to work, study team members must understand all of the following
EXCEPT: - ANSWER-how to perform the other team members' jobs
Typical study conduct activities performed by the data manager include all of the following EXCEPT: -
ANSWER-defining edit checks
At what point should a Data Manager get involved with the database development? - ANSWER-At
study startup
Prior to locking a database, a data manager should ensure all data have been entered and all queries
are resolved. - ANSWER-True
Which of the following is included in the Nuremberg Code:
A. Voluntary consent
B. Confidentiality of data
C. Equitable selection of subjects
D. Additional protection for vulnerable subjects - ANSWER-Voluntary consent
Which of the following brought increased public attention to the problems with the IRB system?
, A. Death of Research Subject (Jesse Gelsinger)
B. "Shut Downs" by OHRP
C. HHS Inspector General Report of 1998
D. 1983 Presidential Commission Report - ANSWER-Death of Research Subject (Jesse Gelsinger)
The use of prisoners in research is a concern under the Belmont principle of Justice because:
A. Prisoners are not a representative sample of the general population
B. Prisoners are not free to say no
C. Prisoners may not be used to conduct research that only benefits the larger society
D. Prisoners are less educated that the general population and have difficulty understanding research
- ANSWER-Prisoners may not be used to conduct research that only benefits the larger society
Informed consent is considered an application of which Belmont principle?
A. Beneficence
B. Justice
C. Non-maleficence
D. Respect for Persons - ANSWER-Respect for persons
Which of the following was the result of the Beecher article?
A. Additional FDA regulations
B. Realization that ethical abuses are not limited to the Nazi regime
C. An identification of basic ethical principles
D. Multiple Congressional hearings - ANSWER-Realization that ethical abuses are not limited to the
Nazi regime
Which of the following statements is accurate in determining subject risk involved in a genetic study: -
ANSWER-Understanding the purpose and context of a specific study is critical in determining the risk
involved
As of January 2015, the NIH expects investigators to obtain the informed (valid) consent of research
participants in NIH -funded genetic research for broad research use of data and data sharing, even if
the cell lines or specimens are: - ANSWER-De-Identified
Under which of the following conditions is it appropriate to re-contact the individuals who provided
biological specimens? - ANSWER-Original signed consent documents include provisions for
recontacting subjects
Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA)
protects individuals from: - ANSWER-Health insurance and employment discrimination
Which choice is the best definition of "genetic determinism?" - ANSWER-Genes are primarily
responsible for human traits, including health, behavior, and disease
Under which circumstance does the FDA allow verbal consent prior to participation in a research
study?
A. The subject has a legally authorized representative (LAR).
B. The study is minimal risk.
C. The subject is illiterate.
D. The study is greater than minimal risk. - ANSWER-The study is minimal risk.
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
AND ANSWERS
1. Which of the following are the three principles discussed in the Belmont Report? - ANSWER-
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: - ANSWER-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? - ANSWER-Determining that the study has a maximization of benefits and
a minimization of risks.
4. The Data Manager should review the study protocol: - ANSWER-to understand primary and
secondary endpoints
5. When designing a database and data collection instruments for a study, the Data Manager should: -
ANSWER-Use standards to reduce the time required to set up the database and to increase the
consistency of the data
Every member of a study team must define quality the same way in order to produce a high quality
database. - ANSWER-False
Which member of a study team is ultimately responsible for the conduct of the study at a site? -
ANSWER-The Investigator
Which member of a study team acts as the liaison between a sponsor and site, ensuring that reported
data are verifiable to source documentation? - ANSWER-The Clinical Research Associate
In order for a quality process to work, study team members must understand all of the following
EXCEPT: - ANSWER-how to perform the other team members' jobs
Typical study conduct activities performed by the data manager include all of the following EXCEPT: -
ANSWER-defining edit checks
At what point should a Data Manager get involved with the database development? - ANSWER-At
study startup
Prior to locking a database, a data manager should ensure all data have been entered and all queries
are resolved. - ANSWER-True
Which of the following is included in the Nuremberg Code:
A. Voluntary consent
B. Confidentiality of data
C. Equitable selection of subjects
D. Additional protection for vulnerable subjects - ANSWER-Voluntary consent
Which of the following brought increased public attention to the problems with the IRB system?
, A. Death of Research Subject (Jesse Gelsinger)
B. "Shut Downs" by OHRP
C. HHS Inspector General Report of 1998
D. 1983 Presidential Commission Report - ANSWER-Death of Research Subject (Jesse Gelsinger)
The use of prisoners in research is a concern under the Belmont principle of Justice because:
A. Prisoners are not a representative sample of the general population
B. Prisoners are not free to say no
C. Prisoners may not be used to conduct research that only benefits the larger society
D. Prisoners are less educated that the general population and have difficulty understanding research
- ANSWER-Prisoners may not be used to conduct research that only benefits the larger society
Informed consent is considered an application of which Belmont principle?
A. Beneficence
B. Justice
C. Non-maleficence
D. Respect for Persons - ANSWER-Respect for persons
Which of the following was the result of the Beecher article?
A. Additional FDA regulations
B. Realization that ethical abuses are not limited to the Nazi regime
C. An identification of basic ethical principles
D. Multiple Congressional hearings - ANSWER-Realization that ethical abuses are not limited to the
Nazi regime
Which of the following statements is accurate in determining subject risk involved in a genetic study: -
ANSWER-Understanding the purpose and context of a specific study is critical in determining the risk
involved
As of January 2015, the NIH expects investigators to obtain the informed (valid) consent of research
participants in NIH -funded genetic research for broad research use of data and data sharing, even if
the cell lines or specimens are: - ANSWER-De-Identified
Under which of the following conditions is it appropriate to re-contact the individuals who provided
biological specimens? - ANSWER-Original signed consent documents include provisions for
recontacting subjects
Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA)
protects individuals from: - ANSWER-Health insurance and employment discrimination
Which choice is the best definition of "genetic determinism?" - ANSWER-Genes are primarily
responsible for human traits, including health, behavior, and disease
Under which circumstance does the FDA allow verbal consent prior to participation in a research
study?
A. The subject has a legally authorized representative (LAR).
B. The study is minimal risk.
C. The subject is illiterate.
D. The study is greater than minimal risk. - ANSWER-The study is minimal risk.
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
