CITI TRAINING QUIZ EXAM 2026/2027
QUESTIONS AND CORRECT ANSWERS
(VERIFIED ANSWERS) PLUS RATIONALES
2026 Q&A | INSTANT DOWNLOAD PDF.
CORE DOMAINS
1. Historical Perspective and Ethical Principles
2. IRB Authority, Membership, and Functions
3. Informed Consent Process and Documentation
4. Vulnerable Populations in Research
5. Privacy, Confidentiality, and HIPAA
6. Conflicts of Interest and Objectivity in Research
7. Responsible Conduct of Research and Misconduct
8. International Research and Community Engagement
9. Clinical Trials and FDA Regulations
10. Emerging Topics: Genetics, Big Data, and Digital Health
INTRODUCTION
This comprehensive assessment evaluates knowledge of research ethics
and compliance for investigators, IRB members, and institutional
officials. It tests understanding of the Belmont Report principles, federal
regulations including 45 CFR 46, FDA requirements, and ethical
decision-making. The exam emphasizes real-world application through
scenario-based multiple-choice questions covering informed consent,
vulnerable populations, privacy protections, conflicts of interest, and
responsible conduct of research. Each item requires critical thinking and
practical judgment.
SECTION ONE: QUESTIONS 1–100
,1. Which of the following are the three fundamental ethical
principles outlined in the Belmont Report?
A. Respect for Persons, Justice, and Non-maleficence
B. Informed Consent, Risk-Benefit Analysis, and Equitable Selection
C. Respect for Persons, Beneficence, and Justice
D. Privacy, Confidentiality, and Autonomy
C. Respect for Persons, Beneficence, and Justice
RATIONALE: The Belmont Report identifies three core principles:
Respect for Persons, Beneficence, and Justice. Non-maleficence is part
of beneficence but not a separate principle.
2. The Tuskegee Syphilis Study violated which fundamental ethical
principle by failing to obtain informed consent and deceiving
participants?
A. Beneficence only
B. Respect for Persons and Justice
C. Confidentiality only
D. Scientific integrity only
B. Respect for Persons and Justice
RATIONALE: The study violated Respect for Persons by failing to
obtain informed consent and Justice by targeting a vulnerable population
that did not benefit from the research.
3. Which of the following is a required element of informed consent
under the Common Rule (45 CFR 46.116)?
A. The name of the study sponsor
B. A statement that the subject may withdraw at any time without
penalty
,C. The specific salary of the principal investigator
D. A guarantee that the research involves no risk
B. A statement that the subject may withdraw at any time without
penalty
RATIONALE: The Common Rule requires a statement that
participation is voluntary and the subject may discontinue at any time
without penalty.
4. According to the Belmont Report, which principle requires that
subjects be treated fairly and that the benefits and burdens of
research be distributed equitably?
A. Respect for persons
B. Beneficence
C. Justice
D. Scientific validity
C. Justice
RATIONALE: The principle of Justice requires fair distribution of
research benefits and burdens, ensuring vulnerable populations are not
disproportionately selected for risky research.
5. The principle of beneficence in research requires that:
A. Subjects derive direct individual benefit from participating in the
study
B. The research must make a significant contribution to generalizable
knowledge
C. Anticipated benefits justify the risks of harm to participants
D. All research risks are managed to a minimal level
C. Anticipated benefits justify the risks of harm to participants
, RATIONALE: Beneficence requires that the potential benefits of the
study must be carefully weighed against the potential risks, and benefits
must justify the risks.
6. Under 45 CFR 46, research involving pregnant women, fetuses,
and neonates requires:
A. No special protections beyond standard informed consent
B. Additional safeguards including justification of risk and direct benefit
requirements
C. Only that the father provides consent
D. Automatic exclusion from all research
B. Additional safeguards including justification of risk and direct
benefit requirements
RATIONALE: Subpart B of 45 CFR 46 provides specific additional
protections requiring justification of risk and direct benefit requirements.
7. Which of the following constitutes human subjects research under
45 CFR 46?
A. Analysis of publicly available, de-identified data sets
B. Interaction or intervention with living individuals for research
purposes
C. Quality improvement activities with no generalizable knowledge
intent
D. Analysis of deceased patient records only
B. Interaction or intervention with living individuals for research
purposes
QUESTIONS AND CORRECT ANSWERS
(VERIFIED ANSWERS) PLUS RATIONALES
2026 Q&A | INSTANT DOWNLOAD PDF.
CORE DOMAINS
1. Historical Perspective and Ethical Principles
2. IRB Authority, Membership, and Functions
3. Informed Consent Process and Documentation
4. Vulnerable Populations in Research
5. Privacy, Confidentiality, and HIPAA
6. Conflicts of Interest and Objectivity in Research
7. Responsible Conduct of Research and Misconduct
8. International Research and Community Engagement
9. Clinical Trials and FDA Regulations
10. Emerging Topics: Genetics, Big Data, and Digital Health
INTRODUCTION
This comprehensive assessment evaluates knowledge of research ethics
and compliance for investigators, IRB members, and institutional
officials. It tests understanding of the Belmont Report principles, federal
regulations including 45 CFR 46, FDA requirements, and ethical
decision-making. The exam emphasizes real-world application through
scenario-based multiple-choice questions covering informed consent,
vulnerable populations, privacy protections, conflicts of interest, and
responsible conduct of research. Each item requires critical thinking and
practical judgment.
SECTION ONE: QUESTIONS 1–100
,1. Which of the following are the three fundamental ethical
principles outlined in the Belmont Report?
A. Respect for Persons, Justice, and Non-maleficence
B. Informed Consent, Risk-Benefit Analysis, and Equitable Selection
C. Respect for Persons, Beneficence, and Justice
D. Privacy, Confidentiality, and Autonomy
C. Respect for Persons, Beneficence, and Justice
RATIONALE: The Belmont Report identifies three core principles:
Respect for Persons, Beneficence, and Justice. Non-maleficence is part
of beneficence but not a separate principle.
2. The Tuskegee Syphilis Study violated which fundamental ethical
principle by failing to obtain informed consent and deceiving
participants?
A. Beneficence only
B. Respect for Persons and Justice
C. Confidentiality only
D. Scientific integrity only
B. Respect for Persons and Justice
RATIONALE: The study violated Respect for Persons by failing to
obtain informed consent and Justice by targeting a vulnerable population
that did not benefit from the research.
3. Which of the following is a required element of informed consent
under the Common Rule (45 CFR 46.116)?
A. The name of the study sponsor
B. A statement that the subject may withdraw at any time without
penalty
,C. The specific salary of the principal investigator
D. A guarantee that the research involves no risk
B. A statement that the subject may withdraw at any time without
penalty
RATIONALE: The Common Rule requires a statement that
participation is voluntary and the subject may discontinue at any time
without penalty.
4. According to the Belmont Report, which principle requires that
subjects be treated fairly and that the benefits and burdens of
research be distributed equitably?
A. Respect for persons
B. Beneficence
C. Justice
D. Scientific validity
C. Justice
RATIONALE: The principle of Justice requires fair distribution of
research benefits and burdens, ensuring vulnerable populations are not
disproportionately selected for risky research.
5. The principle of beneficence in research requires that:
A. Subjects derive direct individual benefit from participating in the
study
B. The research must make a significant contribution to generalizable
knowledge
C. Anticipated benefits justify the risks of harm to participants
D. All research risks are managed to a minimal level
C. Anticipated benefits justify the risks of harm to participants
, RATIONALE: Beneficence requires that the potential benefits of the
study must be carefully weighed against the potential risks, and benefits
must justify the risks.
6. Under 45 CFR 46, research involving pregnant women, fetuses,
and neonates requires:
A. No special protections beyond standard informed consent
B. Additional safeguards including justification of risk and direct benefit
requirements
C. Only that the father provides consent
D. Automatic exclusion from all research
B. Additional safeguards including justification of risk and direct
benefit requirements
RATIONALE: Subpart B of 45 CFR 46 provides specific additional
protections requiring justification of risk and direct benefit requirements.
7. Which of the following constitutes human subjects research under
45 CFR 46?
A. Analysis of publicly available, de-identified data sets
B. Interaction or intervention with living individuals for research
purposes
C. Quality improvement activities with no generalizable knowledge
intent
D. Analysis of deceased patient records only
B. Interaction or intervention with living individuals for research
purposes
